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1.  The FEeding Support Team (FEST) randomised, controlled feasibility trial of proactive and reactive telephone support for breastfeeding women living in disadvantaged areas 
BMJ Open  2012;2(2):e000652.
Objective
To assess the feasibility of implementing a dedicated feeding support team on a postnatal ward and pilot the potential effectiveness and cost-effectiveness of team (proactive) and woman-initiated (reactive) telephone support after discharge.
Design
Randomised controlled trial embedded within a before-and-after study. Participatory approach and mixed-method process evaluation.
Setting
A postnatal ward in Scotland.
Sample
Women living in disadvantaged areas initiating breast feeding.
Methods
Eligible women were recruited to a before-and-after intervention study, a proportion of whom were independently randomised after hospital discharge to intervention: daily proactive and reactive telephone calls for ≤14 days or control: reactive telephone calls ≤ day 14. Intention-to-treat analysis compared the randomised groups on cases with complete outcomes at follow-up.
Main outcome measures
Primary outcome: any breast feeding at 6–8 weeks assessed by a telephone call from a researcher blind to group allocation. Secondary outcomes: exclusive breast feeding, satisfaction with care, NHS costs and cost per additional woman breast feeding.
Results
There was no difference in feeding outcomes for women initiating breast feeding before the intervention (n=413) and after (n=388). 69 women were randomised to telephone support: 35 intervention (32 complete cases) and 34 control (26 complete cases). 22 intervention women compared with 12 control women were giving their baby some breast milk (RR 1.49, 95% CI 0.92 to 2.40) and 17 intervention women compared with eight control women were exclusively breast feeding (RR 1.73, 95% CI 0.88 to 3.37) at 6–8 weeks after birth. The incremental cost of providing proactive calls was £87 per additional woman breast feeding and £91 per additional woman exclusively breast feeding at 6–8 weeks; costs were sensitive to service organisation.
Conclusions
Proactive telephone care delivered by a dedicated feeding team shows promise as a cost-effective intervention for improving breastfeeding outcomes. Integrating the FEeding Support Team (FEST) intervention into routine postnatal care was feasible.
Trial registration number
ISRCTN27207603. The study protocol and final report are available on request.
Article summary
Article focus
To pilot the potential effectiveness and cost-effectiveness of continuing proactive and reactive telephone support for breast feeding for up to 14 days after hospital discharge for women living in more disadvantaged areas.
To assess the feasibility of implementing a dedicated feeding team on a postnatal ward.
To design an effective health service intervention for infant feeding by re-organising how routine care is provided to inform a larger programme of research.
Key messages
Proactive telephone care delivered by a dedicated feeding team shows promise for increasing breastfeeding rates 6–8 weeks after birth.
Only having a dedicated feeding team on a postnatal ward did not appear to make any difference to feeding outcomes at 6–8 weeks after birth.
We have demonstrated the feasibility of (1) implementing the FEeding Support Team intervention as part of routine postnatal care and (2) the recruitment and data collection processes for a proposed definitive trial.
Strengths and limitations of this study
Using a participatory approach and embedding a rigorous randomised control trial within a before-and-after cohort study with mixed methods data to evaluate costs are strengths that will enable us to design a definitive trial.
It is likely that the effect sizes are overestimated as the sample size was small and no sample size calculation was performed prior to the study.
Our sample included women requiring longer hospital stays due to birth complications.
The reactive call service was only free to those who had the same mobile phone network provider.
The incremental cost-effectiveness ratios presented represent the most favourable set of assumptions for proactive telephone support and are sensitive to how the service is organised.
doi:10.1136/bmjopen-2011-000652
PMCID: PMC3341594  PMID: 22535790
2.  Ringing Up about Breastfeeding: a randomised controlled trial exploring early telephone peer support for breastfeeding (RUBY) – trial protocol 
Background
The risks of not breastfeeding for mother and infant are well established, yet in Australia, although most women initiate breastfeeding many discontinue breastfeeding altogether and few women exclusively breastfeed to six months as recommended by the World Health Organization and Australian health authorities. We aim to determine whether proactive telephone peer support during the postnatal period increases the proportion of infants who are breastfed at six months, replicating a trial previously found to be effective in Canada.
Design/Methods
A two arm randomised controlled trial will be conducted, recruiting primiparous women who have recently given birth to a live baby, are proficient in English and are breastfeeding or intending to breastfeed. Women will be recruited in the postnatal wards of three hospitals in Melbourne, Australia and will be randomised to peer support or to ‘usual’ care. All women recruited to the trial will receive usual hospital postnatal care and infant feeding support. For the intervention group, peers will make two telephone calls within the first ten days postpartum, then weekly telephone calls until week twelve, with continued contact until six months postpartum. Primary aim: to determine whether postnatal telephone peer support increases the proportion of infants who are breastfed for at least six months. Hypothesis: that telephone peer support in the postnatal period will increase the proportion of infants receiving any breast milk at six months by 10% compared with usual care (from 46% to 56%).
Outcome data will be analysed by intention to treat. A supplementary multivariate analysis will be undertaken if there are any baseline differences in the characteristics of women in the two groups which might be associated with the primary outcomes.
Discussion
The costs and health burdens of not breastfeeding fall disproportionately and increasingly on disadvantaged groups. We have therefore deliberately chosen trial sites which have a high proportion of women from disadvantaged backgrounds. This will be the first Australian randomised controlled trial to test the effectiveness and cost effectiveness of proactive peer telephone support for breastfeeding.
Trial registration
Australian and New Zealand Clinical Trials Registry ACTRN12612001024831.
doi:10.1186/1471-2393-14-177
PMCID: PMC4068322  PMID: 24886264
Breastfeeding; Exclusive breastfeeding; Breastfeeding rates; Peer support; Telephone; Australia
3.  The effectiveness of proactive telephone support provided to breastfeeding mothers of preterm infants: study protocol for a randomized controlled trial 
BMC Pediatrics  2013;13:73.
Background
Although breast milk has numerous benefits for infants’ development, with greater effects in those born preterm (at < 37 gestational weeks), mothers of preterm infants have shorter breastfeeding duration than mothers of term infants. One of the explanations proposed is the difficulties in the transition from a Neonatal Intensive Care Unit (NICU) to the home environment. A person-centred proactive telephone support intervention after discharge from NICU is expected to promote mothers’ sense of trust in their own capacity and thereby facilitate breastfeeding.
Methods/design
A multicentre randomized controlled trial has been designed to evaluate the effectiveness and cost-effectiveness of person-centred proactive telephone support on breastfeeding outcomes for mothers of preterm infants. Participating mothers will be randomized to either an intervention group or control group. In the intervention group person-centred proactive telephone support will be provided, in which the support team phones the mother daily for up to 14 days after hospital discharge. In the control group, mothers are offered a person-centred reactive support where mothers can phone the breastfeeding support team up to day 14 after hospital discharge. The intervention group will also be offered the same reactive telephone support as the control group. A stratified block randomization will be used; group allocation will be by high or low socioeconomic status and by NICU. Recruitment will be performed continuously until 1116 mothers (I: 558 C: 558) have been included. Primary outcome: proportion of mothers exclusively breastfeeding at eight weeks after discharge. Secondary outcomes: proportion of breastfeeding (exclusive, partial, none and method of feeding), mothers satisfaction with breastfeeding, attachment, stress and quality of life in mothers/partners at eight weeks after hospital discharge and at six months postnatal age. Data will be collected by researchers blind to group allocation for the primary outcome. A qualitative evaluation of experiences of receiving/providing the intervention will also be undertaken with mothers and staff.
Discussion
This paper presents the rationale, study design and protocol for a RCT providing person-centred proactive telephone support to mothers of preterm infants. Furthermore, with a health economic evaluation, the cost-effectiveness of the intervention will be assessed.
Trial registration
NCT01806480
doi:10.1186/1471-2431-13-73
PMCID: PMC3654949  PMID: 23663521
Breastfeeding; Mothers; Neonatal care; Preterm infant; Support; Telephone
4.  Two-Year Morbidity–Mortality and Alternatives to Prolonged Breast-Feeding among Children Born to HIV-Infected Mothers in Côte d'Ivoire 
PLoS Medicine  2007;4(1):e17.
Background
Little is known about the long-term safety of infant feeding interventions aimed at reducing breast milk HIV transmission in Africa.
Methods and Findings
In 2001–2005, HIV-infected pregnant women having received in Abidjan, Côte d'Ivoire, a peripartum antiretroviral prophylaxis were presented antenatally with infant feeding interventions: either artificial feeding, or exclusive breast-feeding and then early cessation from 4 mo of age. Nutritional counseling and clinical management were provided for 2 y. Breast-milk substitutes were provided for free. The primary outcome was the occurrence of adverse health outcomes in children, defined as validated morbid events (diarrhea, acute respiratory infections, or malnutrition) or severe events (hospitalization or death). Hazards ratios to compare formula-fed versus short-term breast-fed (reference) children were adjusted for confounders (baseline covariates and pediatric HIV status as a time-dependant covariate). The 18-mo mortality rates were also compared to those observed in the Ditrame historical trial, which was conducted at the same sites in 1995–1998, and in which long-term breast-feeding was practiced in the absence of any specific infant feeding intervention. Of the 557 live-born children, 262 (47%) were breast-fed for a median of 4 mo, whereas 295 were formula-fed. Over the 2-y follow-up period, 37% of the formula-fed and 34% of the short-term breast-fed children remained free from any adverse health outcome (adjusted hazard ratio [HR]: 1.10; 95% confidence interval [CI], 0.87–1.38; p = 0.43). The 2-y probability of presenting with a severe event was the same among formula-fed (14%) and short-term breast-fed children (15%) (adjusted HR, 1.19; 95% CI, 0.75–1.91; p = 0.44). An overall 18-mo probability of survival of 96% was observed among both HIV-uninfected short-term and formula-fed children, which was similar to the 95% probability observed in the long-term breast-fed ones of the Ditrame trial.
Conclusions
The 2-y rates of adverse health outcomes were similar among short-term breast-fed and formula-fed children. Mortality rates did not differ significantly between these two groups and, after adjustment for pediatric HIV status, were similar to those observed among long-term breast-fed children. Given appropriate nutritional counseling and care, access to clean water, and a supply of breast-milk substitutes, these alternatives to prolonged breast-feeding can be safe interventions to prevent mother-to-child transmission of HIV in urban African settings.
Given appropriate nutritional counseling and care, access to clean water, and supply of breast milk substitutes, replacing prolonged breast-feeding with formula-feeding appears to be a safe intervention to prevent mother-to-child transmission of HIV in this setting.
Editors' Summary
Background.
The HIV virus can be transmitted from infected mothers to their babies during pregnancy and birth as well as after birth through breast milk. Mother-to-child transmission in developed countries has been all but eliminated by treatment of mothers with the best available combination of antiretroviral drugs and by asking them to avoid breast-feeding. However, in many developing countries, the best drug treatments are not available to mothers. Moreover, breast-feeding is generally the best nutritional choice for infants, especially in areas where resources such as clean water, formula feed, and provision of healthcare are scarce. And even if formula feed is available, formula-fed babies might be at higher risk of dying from diarrhea and chest infections, which are more common in infants who are not breast-fed. International guidelines say that HIV-positive mothers should avoid all breast-feeding and adopt formula feeding instead if this option is practical and safe for them, which would require that they can afford formula feed and have easy access to clean water. If formula-feeding is not feasible, guidelines recommend that mothers should breast-feed only for the first few months and then stop and switch the baby to solid food. One of these two alternative options should be feasible in most African cities if mothers are given the right support.
Why Was This Study Done?
Several completed and ongoing studies are assessing the relative risks and benefits of the two recommended strategies for different developing country locations, and this is one of them. The study, the “Ditrame Plus” trial by researchers from France and Côte d'Ivoire, was conducted in Abidjan, an urban West African setting. The goal was to compare death rates and rates of certain diseases (such as diarrhea and chest infections) between babies born to HIV-positive mothers that were formula-fed and those that were breast-fed for a short time after birth.
What Did the Researchers Do and Find?
HIV-positive pregnant women were invited to enter the study, and they received short-term drug treatments intended to reduce the risk of HIV transmission to their babies. Women in the trial were then asked to choose one of the two feeding options and offered support and counseling for either one. This support included free formula, transport, and healthcare provision. Babies were followed up to their second birthday, and data were collected on death rates and any serious illnesses. A total of 643 women were enrolled into the study, and safety data were collected for 557 babies, of whom 295 were in the formula group and 262 were in the short-term breast-feeding group. The researchers corrected for HIV infection in the babies and found no evidence that the risk of other negative health outcomes and death rates was any different between the formula-fed babies and short-term breast-fed babies. Looking specifically at individual diseases, the researchers found that the risks for diarrhea and chest infections were slightly higher among formula-fed babies, but this did not translate into a greater risk of death or worse overall health. They also compared the death rates in this study with some historical data from a previous research project done in the same area on children born to HIV-positive mothers who had practiced long-term breast-feeding. The mother-to-child transmission rate of HIV had been much higher in that earlier trial, but looking only at the HIV-negative children, the researchers found no difference in risk for death or serious disease between the formula-fed or short-term breast-fed babies from the Ditrame Plus trial and the long-term breast-fed babies from the earlier trial.
What Do These Findings Mean?
This study shows that if HIV-positive mothers are well supported, either of the two feeding options currently recommended (formula-only feed, or short-term breast-feeding) are likely to be equivalent in terms of the baby's chances for survival and health. However, women in this study were offered a great deal of support and the findings may not necessarily apply to real-life situations in other settings in Africa, or outside the context of a research project. In addition to routine care after birth, access to better drugs to prevent mother-to-child transmission in developing countries remains an important goal.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/doi:10.1371/journal.pmed.0040017.
Resources from Avert (an AIDS charity) on HIV and infant feeding.
Information from the US Centers for Disease Control on mother-to-child transmission of HIV
Guidelines from the World Health Organization on mother-to-child transmission of HIV
AIDSMap pages on breast-feeding and HIV
HIV Care and PMTCT in Resource-Limited Setting contains monthly bulletins and a database devoted to HIV/AIDS infections and prevention of the mother-to-child transmission of HIV
The Ghent group is a network of researchers and policymakers in the area of prevention of mother-to-child transmission of HIV
doi:10.1371/journal.pmed.0040017
PMCID: PMC1769413  PMID: 17227132
5.  Effectiveness of a Home-Based Counselling Strategy on Neonatal Care and Survival: A Cluster-Randomised Trial in Six Districts of Rural Southern Tanzania 
PLoS Medicine  2015;12(9):e1001881.
Background
We report a cluster-randomised trial of a home-based counselling strategy, designed for large-scale implementation, in a population of 1.2 million people in rural southern Tanzania. We hypothesised that the strategy would improve neonatal survival by around 15%.
Methods and Findings
In 2010 we trained 824 female volunteers to make three home visits to women and their families during pregnancy and two visits to them in the first few days of the infant’s life in 65 wards, selected randomly from all 132 wards in six districts in Mtwara and Lindi regions, constituting typical rural areas in Southern Tanzania. The remaining wards were comparison areas. Participants were not blinded to the intervention. The primary analysis was an intention-to-treat analysis comparing the neonatal mortality (day 0–27) per 1,000 live births in intervention and comparison wards based on a representative survey in 185,000 households in 2013 with a response rate of 90%. We included 24,381 and 23,307 live births between July 2010 and June 2013 and 7,823 and 7,555 live births in the last year in intervention and comparison wards, respectively. We also compared changes in neonatal mortality and newborn care practices in intervention and comparison wards using baseline census data from 2007 including 225,000 households and 22,243 births in five of the six intervention districts. Amongst the 7,823 women with a live birth in the year prior to survey in intervention wards, 59% and 41% received at least one volunteer visit during pregnancy and postpartum, respectively. Neonatal mortality reduced from 35.0 to 30.5 deaths per 1,000 live births between 2007 and 2013 in the five districts, respectively. There was no evidence of an impact of the intervention on neonatal survival (odds ratio [OR] 1.1, 95% confidence interval [CI] 0.9–1.2, p = 0.339). Newborn care practices reported by mothers were better in intervention than in comparison wards, including immediate breastfeeding (42% of 7,287 versus 35% of 7,008, OR 1.4, CI 1.3–1.6, p < 0.001), feeding only breast milk for the first 3 d (90% of 7,557 versus 79% of 7,307, OR 2.2, 95% CI 1.8–2.7, p < 0.001), and clean hands for home delivery (92% of 1,351 versus 88% of 1,799, OR 1.5, 95% CI 1.0–2.3, p = 0.033). Facility delivery improved dramatically in both groups from 41% of 22,243 in 2007 and was 82% of 7,820 versus 75% of 7,553 (OR 1.5, 95% CI 1.2–2.0, p = 0.002) in intervention and comparison wards in 2013. Methodological limitations include our inability to rule out some degree of leakage of the intervention into the comparison areas and response bias for newborn care behaviours.
Conclusion
Neonatal mortality remained high despite better care practices and childbirth in facilities becoming common. Public health action to improve neonatal survival in this setting should include a focus on improving the quality of facility-based childbirth care.
Trial Registration
ClinicalTrials.gov NCT01022788
Editors' Summary
Background
In 1990, 12 million children—most of them living in resource-limited countries—died before their fifth birthday. Faced with this largely avoidable loss of young lives, in 2000, world leaders set a target of reducing under-five mortality (deaths) to one-third of its 1990 level by 2015 as Millennium Development Goal 4 (MDG4); this goal, together with seven others, aims to eradicate extreme poverty globally. Progress towards reducing under-five mortality has been good. However, MDG4 has not been met because of slow progress in reducing neonatal mortality—death during the first 28 days of life. In sub-Saharan Africa, for example, mortality during the first five years of life fell by 47% between 1990 and 2012, whereas neonatal mortality fell by only 28%. Consequently, neonatal deaths now account for a greater proportion of global child deaths than in 1990, and every year there are still 3 million neonatal deaths.
Why Was This Study Done?
Experts estimate that advising mothers during pregnancy and in the days following delivery (the early postpartum period) about good delivery and newborn care practices could prevent a quarter of neonatal deaths. WHO and the United Nations Children's Fund (UNICEF) therefore recommend that all mothers in areas with high neonatal mortality should receive two home visits during the early postpartum period to assess the newborn’s health and to counsel mothers on newborn care practices. In this cluster randomized trial, the researchers investigate the effect on neonatal care and survival in rural southern Tanzania, a low-resource setting, of a volunteer-led home-based counseling strategy that meets these recommendations. The neonatal mortality rate (NMR) has declined markedly in recent years in Tanzania but varies widely across the country. A cluster randomized trial randomly assigns groups of people (here, women living in different “wards” consisting of three or four villages) to receive alternative interventions and compares outcomes in the differently treated “clusters.”
What Did the Researchers Do and Find?
The researchers estimated baseline neonatal mortality in five rural districts in southern Tanzania (35 deaths per 1,000 live births) from a 2007 census. In early 2010, they trained 824 female volunteers to deliver key counseling messages (including messages about handwashing with soap before delivery and early and exclusive breast feeding) and supporting messages such as the importance of childbirth in a health care facility. The volunteers were asked to make three home visits during pregnancy and two home visits shortly after delivery to women living in 65 intervention wards in six rural Tanzanian districts (a district not included in the baseline census was included in the trial); 67 comparison wards did not receive the intervention. A 2013 survey of households indicated that, in the intervention wards, 59% of women received at least one volunteer visit during pregnancy and 41% received at least one visit postpartum. Neonatal mortality reduced from 35 to 31 and 30 deaths per 1,000 live births in the intervention and comparison wards, respectively, in the five districts with baseline data. Newborn care practices reported by mothers were better in the intervention wards than in the comparison wards. For example, 42% and 35% of the women in the intervention and comparison wards, respectively, reported immediate breast feeding. Finally, childbirth in a health care facility increased from 41% in 2007 to 82% and 75% in 2013 in the intervention and comparison wards, respectively.
What Do These Findings Mean?
These findings provide no evidence for an effect on neonatal survival of the home-based counseling strategy tested here even though the intervention improved newborn care practices. Notably, although many of the women in the intervention wards received antenatal visits from the trained volunteers, fewer women received early postpartum visits, a finding that could be partly responsible for the lack of effectiveness of the intervention. The accuracy of these findings may be limited by certain aspects of the trial design. For example, some of the women in the comparison areas may have inadvertently received part of the intervention (“leakage”). In addition, newborn care practises improved much in both, intervention and comparison areas, included a doubling of facility delivery. Nevertheless, the lack of an effect of the intervention on neonatal mortality despite a moderate effect on newborn care behaviours throws some doubt on the existing evidence base in support of home-based counselling as an intervention to reduce neonatal mortality. Finally, the finding that childbirth in a health care facility increased during the study period without a concomitant reduction in neonatal mortality highlights the need to improve the quality of facility-based childbirth care in rural southern Tanzania and, possibly, in other resource-limited settings.
Additional Information
This list of resources contains links that can be accessed when viewing the PDF on a device or via the online version of the article at http://dx.doi.org/10.1371/journal.pmed.1001881.
WHO provides information on global efforts to reduce child mortality and on ending preventable neonatal deaths (available in several languages); its 2009 recommendations, "Home Visits for the Newborn Child. A Strategy to Improve Survival," are available
UNICEF works for children’s rights, survival, development, and protection around the world; it provides information about MDG4 and about child health in Tanzania; its website provides detailed statistics about child health; its Committing to Child Survival: A Promise Renewed—Progress Report 2014 addresses neonatal mortality
The Millennium Development Goals 2015 Report is available
The Healthy Newborn Network is an online community of more than 80 partner organizations that addresses critical knowledge gaps in newborn health
More information about the trial described here is available
doi:10.1371/journal.pmed.1001881
PMCID: PMC4587813  PMID: 26418813
6.  The effect of peer support on breast-feeding duration among primiparous women: a randomized controlled trial 
Background
Most mothers stop breast-feeding before the recommended 6 months post partum. A systematic review showed that breast-feeding support programs by health care professionals did not substantially improve breast-feeding outcomes beyond 2 months post partum. We conducted a randomized controlled trial to evaluate the effect of peer (mother-to-mother) support on breast-feeding duration among first-time breast-feeding mothers.
Methods
We recruited 256 breast-feeding mothers from 2 semi-urban community hospitals near Toronto and randomly assigned them to a control group (conventional care) or a peer support group (conventional care plus telephone-based support, initiated within 48 hours after hospital discharge, from a woman experienced with breast-feeding who attended a 2.5-hour orientation session). Follow-up of breast-feeding duration, maternal satisfaction with infant feeding method and perceptions of peer support received was conducted at 4, 8 and 12 weeks post partum.
Results
Significantly more mothers in the peer support group than in the control group continued to breast-feed at 3 months post partum (81.1% v. 66.9%, p = 0.01) and did so exclusively (56.8% v. 40.3%, p = 0.01). Breast-feeding rates at 4, 8 and 12 weeks post partum were 92.4%, 84.8% and 81.1% respectively among the mothers in the peer support group, as compared with 83.9%, 75.0% and 66.9% among those in the control group (p ≤ 0.05 for all time periods). The corresponding relative risks were 1.10 (95% confidence interval [CI] 1.01–2.72) at 4 weeks, 1.13 (95% CI 1.00–1.28) at 8 weeks and 1.21 (95% CI 1.04–1.41) at 12 weeks post partum. In addition, when asked for an overall rating of their feeding experience, significantly fewer mothers in the peer support group than in the control group were dissatisfied (1.5% v. 10.5%) (p = 0.02). Of the 130 mothers who evaluated the peer support intervention, 81.6% were satisfied with their peer volunteer experience and 100% felt that all new breast-feeding mothers should be offered this peer support intervention.
Interpretation
The telephone-based peer support intervention was effective in maintaining breast-feeding to 3 months post partum and improving satisfaction with the infant feeding experience. The high satisfaction with and acceptance of the intervention indicates that breast-feeding peer support programs, in conjunction with professional health services, are effective.
PMCID: PMC99222  PMID: 11800243
7.  Antenatal education and postnatal support strategies for improving rates of exclusive breast feeding: randomised controlled trial 
BMJ : British Medical Journal  2007;335(7620):596.
Objective To investigate whether antenatal breast feeding education alone or postnatal lactation support alone improves rates of exclusive breast feeding compared with routine hospital care.
Design Randomised controlled trial.
Setting A tertiary hospital in Singapore.
Participants 450 women with uncomplicated pregnancies.
Main outcome measures Primary outcomes were rates of exclusive breast feeding at discharge from hospital and two weeks, six weeks, three months, and six months after delivery. Secondary outcomes were rates of any breast feeding.
Results Compared with women who received routine care, women in the postnatal support group were more likely to breastfeed exclusively at two weeks (relative risk 1.82, 95% confidence interval 1.14 to 2.90), six weeks (1.85, 1.11 to 3.09), three months (1.87, 1.03 to 3.41), and six months (2.12, 1.03 to 4.37) postnatally. Women receiving antenatal education were more likely to breast feed exclusively at six weeks (1.73, 1.04 to 2.90), three months (1.92, 1.07 to 3.48), and six months (2.16, 1.05 to 4.43) postnatally. The numbers needed to treat to achieve one woman exclusively breast feeding at six months were 11 (6 to 80) for postnatal support and 10 (6 to 60) for antenatal education. Women who received postnatal support were more likely to exclusively or predominantly breast feed two weeks after delivery compared with women who received antenatal education (1.53, 1.01 to 2.31). The rate of any breastfeeding six weeks after delivery was also higher in the postnatal support group compared with women who received routine care (1.16, 1.02 to 1.31).
Conclusions Antenatal breast feeding education and postnatal lactation support, as single interventions based in hospital both significantly improve rates of exclusive breast feeding up to six months after delivery. Postnatal support was marginally more effective than antenatal education.
Trial registration Clinical Trials NCT00270920.
doi:10.1136/bmj.39279.656343.55
PMCID: PMC1989016  PMID: 17670909
8.  The acceptance and commitment therapy for smoking cessation in the primary health care setting: a study protocol 
BMC Public Health  2015;15:105.
Background
Access to effective smoking cessation programs is crucial to reducing smoking-related morbidity and mortality. Several studies have shown promising results for the application of Acceptance and Commitment Therapy (ACT) in managing psychological or behavioral health problems. However, to date, only one study has examined the feasibility of a telephone-based ACT for smoking cessation and it was conducted among a Western population, in the United States. This study reports a protocol for a randomized controlled trial (RCT) examining the feasibility and potential efficacy of an individual, telephone-delivered ACT for smoking cessation in primary healthcare settings among a Chinese population.
Methods
A randomized, two-group design was chosen, with assessment at baseline (before intervention) and via telephone follow-ups at three and six months. Subjects will be proactively recruited from primary healthcare centers. Eligible participants will be randomized to either the intervention (ACT) or control group following the baseline assessment. Both groups will receive self-help materials on smoking cessation. Those in the ACT group will undergo an initial face-to-face session and two telephone ACT sessions at one week and one month following the first session, to be delivered by a counselor based on the treatment protocol. All of the participants will be contacted by telephone for follow-up assessments at three and six months. Treatment fidelity will be assessed by reviewing around one-fifth of audio-recorded telephone calls.
Discussion
To the best of our knowledge, this protocol describes the first RCT of a telephone-based ACT for smoking cessation. It is also the first RCT of ACT for smoking cessation on a Chinese population. The study will provide us with information about the feasibility of a telephone-delivered ACT within a Chinese sample. If effective, this trial will support the development of ACT treatment protocols that could be made available for use by a greater range of clinicians, and offer an evidence base to support alternative treatments for smoking cessation.
Trial registration
ClinicalTrials.gov ID NCT01652508. Registered on 26th July 2012.
doi:10.1186/s12889-015-1485-z
PMCID: PMC4389806  PMID: 25879419
Acceptance and commitment therapy; Telephone follow-up; Smoking cessation; Primary health care; Randomized controlled trial (RCT)
9.  A serial qualitative interview study of infant feeding experiences: idealism meets realism 
BMJ Open  2012;2(2):e000504.
Objective
To investigate the infant feeding experiences of women and their significant others from pregnancy until 6 months after birth to establish what would make a difference.
Design
Qualitative serial interview study.
Setting
Two health boards in Scotland.
Participants
72 of 541 invited pregnant women volunteered. 220 interviews approximately every 4 weeks with 36 women, 26 partners, eight maternal mothers, one sister and two health professionals took place.
Results
The overarching theme was a clash between overt or covert infant feeding idealism and the reality experienced. This is manifest as pivotal points where families perceive that the only solution that will restore family well-being is to stop breast feeding or introduce solids. Immediate family well-being is the overriding goal rather than theoretical longer term health benefits. Feeding education is perceived as unrealistic, overly technical and rules based which can undermine women's confidence. Unanimously families would prefer the balance to shift away from antenatal theory towards more help immediately after birth and at 3–4 months when solids are being considered. Family-orientated interactive discussions are valued above breastfeeding-centred checklist style encounters.
Conclusions
Adopting idealistic global policy goals like exclusive breast feeding until 6 months as individual goals for women is unhelpful. More achievable incremental goals are recommended. Using a proactive family-centred narrative approach to feeding care might enable pivotal points to be anticipated and resolved. More attention to the diverse values, meanings and emotions around infant feeding within families could help to reconcile health ideals with reality.
Article summary
Article focus
To investigate the perspectives of women and their wider family and social network on infant feeding from pregnancy until 6 months after birth.
To ascertain what would make a difference to their experiences of breast feeding and the introduction of other fluids and solids.
To focus on health inequalities and to understand interactions between women, professionals, organisations and systems to inform policy, practice and the design of complex intervention trials to improve infant feeding outcomes.
Key messages
Clashes between overt or covert idealism and realism within and between families and the health service occur at pivotal points particularly in the early weeks after birth and around the introduction of solids.
At pivotal points, families often perceive the only solution within their control that will restore family well-being is to stop breast feeding or introduce solids or other fluids. Using a family-centred narrative approach could enable pivotal points to be anticipated and resolved.
Translating global policy goals like exclusive breast feeding until 6 months into practice is unhelpful and achievable incremental goal setting is recommended.
Strengths and limitations of this study
Original interpretation using robust and transparent methods in a relatively large data set of serial interviews about infant feeding, with recruitment of women living in more disadvantaged areas.
Findings which are relevant to current policy and practice, particularly the Unicef Baby Friendly initiative.
An explicit aim to elicit the views of women and their significant others to inform future intervention studies, policy and practice.
Our findings are hypothesis generating rather than hypothesis testing.
It is uncertain how transferable our data is outside the UK context, particularly to countries where breast feeding prevalence is high.
Although we targeted more disadvantaged areas for recruitment, our sample was more economically advantaged than we would have liked.
doi:10.1136/bmjopen-2011-000504
PMCID: PMC3307036  PMID: 22422915
10.  Development and evaluation of a Chinese-language newborn feeding hotline: A prospective cohort study 
Background
Preference for formula versus breast feeding among women of Chinese descent remains a concern in North America. The goal of this study was to develop an intervention targeting Chinese immigrant mothers to increase their rates of exclusive breastfeeding.
Methods
We convened a focus group of immigrant women of Chinese descent in Vancouver, British Columbia to explore preferences for method of infant feeding. We subsequently surveyed 250 women of Chinese descent to validate focus group findings. Using a participatory approach, our focus group participants reviewed survey findings and developed a priority list for attributes of a community-based intervention to support exclusive breastfeeding in the Chinese community. The authors and focus group participants worked as a team to plan, implement and evaluate a Chinese language newborn feeding information telephone service staffed by registered nurses fluent in Chinese languages.
Results
Participants in the focus group reported a strong preference for formula feeding. Telephone survey results revealed that while pregnant Chinese women understood the benefits of breastfeeding, only 20.8% planned to breastfeed exclusively. Only 15.6% were breastfeeding exclusively at two months postpartum. After implementation of the feeding hotline, 20% of new Chinese mothers in Vancouver indicated that they had used the hotline. Among these women, the rate of exclusive breastfeeding was 44.1%; OR 3.02, (95% CI 1.78–5.09) compared to women in our survey.
Conclusion
Initiation of a language-specific newborn feeding telephone hotline reached a previously underserved population and may have contributed to improved rates of exclusive breastfeeding.
doi:10.1186/1471-2393-9-3
PMCID: PMC2637834  PMID: 19178746
11.  1What do first-time mothers worry about? A study of usage patterns and content of calls made to a postpartum support telephone hotline 
BMC Public Health  2010;10:611.
Background
Telephone hotlines designed to address common concerns in the early postpartum could be a useful resource for parents. Our aim was to test the feasibility of using a telephone as an intervention in a randomized controlled trial. We also aimed to test to use of algorithms to address parental concerns through a telephone hotline.
Methods
Healthy first-time mothers were recruited from postpartum wards of hospitals throughout Lebanon. Participants were given the number of a 24-hour telephone hotline that they could access for the first four months after delivery. Calls were answered by a midwife using algorithms developed by the study team whenever possible. Callers with medical complaints were referred to their physicians. Call patterns and content were recorded and analyzed.
Results
Eighty-four of the 353 women enrolled (24%) used the hotline. Sixty percent of the women who used the service called more than once, and all callers reported they were satisfied with the service. The midwife received an average of three calls per day and most calls occurred during the first four weeks postpartum. Our algorithms were used to answer questions in 62.8% of calls and 18.6% of calls required referral to a physician. Of the questions related to mothers, 66% were about breastfeeding. Sixty percent of questions related to the infant were about routine care and 23% were about excessive crying.
Conclusions
Utilization of a telephone hotline service for postpartum support is highest in the first four weeks postpartum. Most questions are related to breastfeeding, routine newborn care, and management of a fussy infant. It is feasible to test a telephone hotline as an intervention in a randomized controlled trial. Algorithms can be developed to provide standardized answers to the most common questions.
doi:10.1186/1471-2458-10-611
PMCID: PMC2965723  PMID: 20946690
12.  Implementation of a new prenatal care model to reduce office visits and increase connectivity and continuity of care: protocol for a mixed-methods study 
Background
Most low-risk pregnant women receive the standard model of prenatal care with frequent office visits. Research suggests that a reduced schedule of visits among low-risk women could be implemented without increasing adverse maternal or fetal outcomes, but patient satisfaction with these models varies. We aim to determine the effectiveness and feasibility of a new prenatal care model (OB Nest) that enhances a reduced visit model by adding virtual connections that improve continuity of care and patient-directed access to care.
Methods and design
This mixed-methods study uses a hybrid effectiveness-implementation design in a single center randomized controlled trial (RCT). Embedding process evaluation in an experimental design like an RCT allows researchers to answer both “Did it work?” and “How or why did it work (or not work)?” when studying complex interventions, as well as providing knowledge for translation into practice after the study. The RE-AIM framework was used to ensure attention to evaluating program components in terms of sustainable adoption and implementation.
Low-risk patients recruited from the Obstetrics Division at Mayo Clinic (Rochester, MN) will be randomized to OB Nest or usual care. OB Nest patients will be assigned to a dedicated nursing team, scheduled for 8 pre-planned office visits with a physician or midwife and 6 telephone or online nurse visits (compared to 12 pre-planned physician or midwife office visits in the usual care group), and provided fetal heart rate and blood pressure home monitoring equipment and information on joining an online care community.
Quantitative methods will include patient surveys and medical record abstraction. The primary quantitative outcome is patient-reported satisfaction. Other outcomes include fidelity to items on the American Congress of Obstetricians and Gynecologists standards of care list, health care utilization (e.g. numbers of antenatal office visits), and maternal and fetal outcomes (e.g. gestational age at delivery), as well as validated patient-reported measures of pregnancy-related stress and perceived quality of care. Quantitative analysis will be performed according to the intention to treat principle. Qualitative methods will include interviews and focus groups with providers, staff, and patients, and will explore satisfaction, intervention adoption, and implementation feasibility. We will use methods of qualitative thematic analysis at three stages. Mixed methods analysis will involve the use of qualitative data to lend insight to quantitative findings.
Discussion
This study will make important contributions to the literature on reduced visit models by evaluating a novel prenatal care model with components to increase patient connectedness (even with fewer pre-scheduled office visits), as demonstrated on a range of patient-important outcomes. The use of a hybrid effectiveness-implementation approach, as well as attention to patient and provider perspectives on program components and implementation, may uncover important information that can inform long-term feasibility and potentially speed future translation.
Trial registration
Trial registration identifier: NCT02082275
Submitted: March 6, 2014
Electronic supplementary material
The online version of this article (doi:10.1186/s12884-015-0762-2) contains supplementary material, which is available to authorized users.
doi:10.1186/s12884-015-0762-2
PMCID: PMC4668747  PMID: 26631000
Prenatal care; Patient-focused care; Health services research; Program evaluation
13.  Telephone care coordination for smokers in VA mental health clinics: protocol for a hybrid type-2 effectiveness-implementation trial 
Background
This paper describes an innovative protocol for a type-II hybrid effectiveness-implementation trial that is evaluating a smoking cessation telephone care coordination program for Veterans Health Administration (VA) mental-health clinic patients. As a hybrid trial, the protocol combines implementation science and clinical trial methods and outcomes that can inform future cessation studies and the implementation of tobacco cessation programs into routine care. The primary objectives of the trial are (1) to evaluate the process of adapting, implementing, and sustaining a smoking cessation telephone care coordination program in VA mental health clinics, (2) to determine the effectiveness of the program in promoting long-term abstinence from smoking among mental health patients, and (3) to compare the effectiveness of telephone counseling delivered by VA staff with that delivered by state quitlines.
Methods/design
The care coordination program is being implemented at six VA facilities. VA mental health providers refer patients to the program via an electronic medical record consult. Program staff call referred patients to offer enrollment. All patients who enroll receive a self-help booklet, mailed smoking cessation medications, and proactive multi-call telephone counseling. Participants are randomized to receive this counseling from VA staff or their state’s quitline. Four primary implementation strategies are being used to optimize program implementation and sustainability: blended facilitation, provider training, informatics support, and provider feedback. A three-phase formative evaluation is being conducted to identify barriers to, and facilitators for, program implementation and sustainability. A mixed-methods approach is being used to collect quantitative clinical effectiveness data (e.g., self-reported abstinence at six months) and both quantitative and qualitative implementation data (e.g., provider referral rates, coded interviews with providers). Summative data will be analyzed using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework.
Discussion
This paper describes the rationale and methods of a trial designed to simultaneously study the clinical effectiveness and implementation of a telephone smoking cessation program for smokers using VA mental health clinics. Such hybrid designs are an important methodological design that can shorten the time between the development of an intervention and its translation into routine clinical care.
Trial registration
ClinicalTrials.gov NCT00724308
doi:10.1186/1940-0640-8-7
PMCID: PMC3636068  PMID: 23497630
Tobacco; Smoking; Mental health; Intervention; Implementation; Psychiatry
14.  A qualitative study exploring the acceptability of the McNulty-Zelen design for randomised controlled trials evaluating educational interventions 
BMC Family Practice  2015;16:169.
Background
Traditional randomised controlled trials evaluating the effect of educational interventions in general practice may produce biased results as participants know they are being evaluated. We aimed to explore the acceptability of a McNulty-Zelen Cluster Randomised Control Trial (CRT) design which conceals from educational participants that they are in a RCT. Consent is obtained from a trusted third party considered appropriate to give consent on participants’ behalf, intervention practice staff then choose whether to attend the offered education as would occur with normal continuing professional development.
Methods
We undertook semi structured telephone interviews in England with 16 general practice (GP) staff involved in a RCT evaluating an educational intervention aimed at increasing chlamydia screening tests in general practice using the McNulty-Zelen design, 4 Primary Care (PC) Research Network officers, 5 Primary Care Trust leads in Public or sexual health, and one Research Ethics committee Chair. Interviews were undertaken by members of the original intervention evaluation McNulty-Zelen design RCT study team. These experienced qualitative interviewers used an agreed semi-structured interview schedule and were careful not to lead the participants. To further mitigate against bias, the data analysis was undertaken by a researcher (CR) not involved in the original RCT.
Results
We reached data saturation and found five main themes;
Support for the design: All found the McNulty-Zelen design acceptable because they considered that it generated more reliable evidence of the value of new educational interventions in real life GP settings.
Lack of familiarity with study design: The design was novel to all. GP staff likened the evaluation using the McNulty–Zelen design to audit of their activities with feedback, which were to them a daily experience and therefore acceptable.
Ethical considerations: Research stakeholders considered the consent procedure should be very clear and that these trial designs should go through at least a proportionate ethical review. GP staff were happy for the PCT leads to give consent on their behalf.
GP research capacity and trial participation: GP staff considered the design increased generalisability, as staff who would not normally volunteer to participate in research due to perceived time constraints and paperwork might do so.
Design ‘worth it’: All interviewees agreed that the advantages of the “more accurate” or “truer” results and information gained about uptake of workshops within Primary Care Trusts (PCTs) outweighed any disadvantages of the consent procedure.
Discussion
Our RCT was evaluating the effect of an educational intervention to increase chlamydia screening tests in general practices where there was routine monitoring of testing rates; our participants may have been less enthusiastic about the design if it had been evaluating a more controversial educational area, or if data monitoring was not routine.
Implications
The McNulty-Zelen design should be considered for the evaluation of educational interventions, but these designs should have clear consent protocols and proportionate ethical review.
Trial registration
The trial was registered on the UK Clinical Research Network Study Portfolio database. UKCRN9722.
Electronic supplementary material
The online version of this article (doi:10.1186/s12875-015-0356-0) contains supplementary material, which is available to authorized users.
doi:10.1186/s12875-015-0356-0
PMCID: PMC4647292  PMID: 26577832
Education for Health Care Professionals; Clinical trials (epidemiology); Public Health Ethics; Primary Care; Ethics; Screening
15.  Evaluation of a community health worker intervention and the World Health Organization’s Option B versus Option A to improve antenatal care and PMTCT outcomes in Dar es Salaam, Tanzania: study protocol for a cluster-randomized controlled health systems implementation trial 
Trials  2014;15:359.
Background
Mother-to-child transmission of HIV remains an important public health problem in sub-Saharan Africa. As HIV testing and linkage to PMTCT occurs in antenatal care (ANC), major challenges for any PMTCT option in developing countries, including Tanzania, are delays in the first ANC visit and a low overall number of visits. Community health workers (CHWs) have been effective in various settings in increasing the uptake of clinical services and improving treatment retention and adherence. At the beginning of this trial in January 2013, the World Health Organization recommended either of two medication regimens, Option A or B, for prevention of mother-to-child transmission of HIV (PMTCT). It is still largely unclear which option is more effective when implemented in a public healthcare system. This study aims to determine the effectiveness, cost-effectiveness, acceptability, and feasibility of: (1) a community health worker (CWH) intervention and (2) PMTCT Option B in improving ANC and PMTCT outcomes.
Methods/Design
This study is a cluster-randomized controlled health systems implementation trial with a two-by-two factorial design. All 60 administrative wards in the Kinondoni and Ilala districts in Dar es Salaam were first randomly allocated to either receiving the CHW intervention or not, and then to receiving either Option B or A. Under the standard of care, facility-based health workers follow up on patients who have missed scheduled appointments for PMTCT, first through a telephone call and then with a home visit. In the wards receiving the CHW intervention, the CHWs: (1) identify pregnant women through home visits and refer them to antenatal care; (2) provide education to pregnant women on antenatal care, PMTCT, birth, and postnatal care; (3) routinely follow up on all pregnant women to ascertain whether they have attended ANC; and (4) follow up on women who have missed ANC or PMTCT appointments.
Trial registration
ClinicalTrials.gov: EJF22802. Registration date: 14 May 2013.
Electronic supplementary material
The online version of this article (doi:10.1186/1745-6215-15-359) contains supplementary material, which is available to authorized users.
doi:10.1186/1745-6215-15-359
PMCID: PMC4247663  PMID: 25224756
Study protocol; HIV; Antenatal care; Prevention of mother-to-child transmission; Community health workers; Uptake; Retention
16.  Effect on Postpartum Hemorrhage of Prophylactic Oxytocin (10 IU) by Injection by Community Health Officers in Ghana: A Community-Based, Cluster-Randomized Trial 
PLoS Medicine  2013;10(10):e1001524.
Cynthia Stanton and colleagues conducted a cluster-randomized controlled trial in rural Ghana to assess whether oxytocin given by injection by community health officers at home births was a feasible and safe option in preventing postpartum hemorrhage.
Please see later in the article for the Editors' Summary
Background
Oxytocin (10 IU) is the drug of choice for prevention of postpartum hemorrhage (PPH). Its use has generally been restricted to medically trained staff in health facilities. We assessed the effectiveness, safety, and feasibility of PPH prevention using oxytocin injected by peripheral health care providers without midwifery skills at home births.
Methods and Findings
This community-based, cluster-randomized trial was conducted in four rural districts in Ghana. We randomly allocated 54 community health officers (stratified on district and catchment area distance to a health facility: ≥10 km versus <10 km) to intervention (one injection of oxytocin [10 IU] one minute after birth) and control (no provision of prophylactic oxytocin) arms. Births attended by a community health officer constituted a cluster. Our primary outcome was PPH, using multiple definitions; (PPH-1) blood loss ≥500 mL; (PPH-2) PPH-1 plus women who received early treatment for PPH; and (PPH-3) PPH-2 plus any other women referred to hospital for postpartum bleeding. Unsafe practice is defined as oxytocin use before delivery of the baby. We enrolled 689 and 897 women, respectively, into oxytocin and control arms of the trial from April 2011 to November 2012. In oxytocin and control arms, respectively, PPH-1 rates were 2.6% versus 5.5% (RR: 0.49; 95% CI: 0.27–0.88); PPH-2 rates were 3.8% versus 10.8% (RR: 0.35; 95% CI: 0.18–0.63), and PPH-3 rates were similar to those of PPH-2. Compared to women in control clusters, those in the intervention clusters lost 45.1 mL (17.7–72.6) less blood. There were no cases of oxytocin use before delivery of the baby and no major adverse events requiring notification of the institutional review boards. Limitations include an unblinded trial and imbalanced numbers of participants, favoring controls.
Conclusion
Maternal health care planners can consider adapting this model to extend the use of oxytocin into peripheral settings including, in some contexts, home births.
Trial registration
ClinicalTrials.gov NCT01108289
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Many women in low-and middle-income countries die unnecessarily during childbirth, even though the solutions to prevent or manage complications are well known. Maternal death rates are highest amongst poor women living in remote areas, as they are least likely to have access to adequate health care. One of the United Nation's Millennium Development Goals is to reduce maternal death rates by three-quarters by 2015. Between 1990 and 2010, these rates were nearly halved. So there is still some way to go to meet the target.
One of the major causes of maternal death is excessive bleeding after birth, known as postpartum hemorrhage (PPH). The highest rates of PPH are found in Africa (28% of births), with an overall global rate of 11%. PPH can be caused by the uterus not contracting after the baby is born, damage to tissues and blood vessels, retention of the placenta, and problems with blood-clotting.
PPH can be prevented by an injection of oxytocin (a hormone) or with tablets of the drug misoprostol immediately after birth. Other drugs exist but are used much less frequently in low-income countries. If the mother does bleed excessively, then these interventions can also be used to treat PPH in the hours following birth. These drugs cause the uterus to contract. Continued severe bleeding requires emergency treatment in hospital. The World Health Organization (WHO) recommends that in situations where women give birth without the assistance of a trained midwife, priority should be given to preventing PPH because access to emergency services may be limited.
Why Was This Study Done?
Of the two most common options for preventing PPH, oxytocin is generally the preferred choice. It has the advantage of having no side effects, whereas misoprostol can cause fever and shivering. A repeat injection of oxytocin can also be given if the mother continues to bleed excessively, whereas a dose of misoprostol after birth should only be given once. A major concern about both drugs is that the timing of administration must be precise. Giving a drug that causes the uterus to contract before birth can be harmful to both mother and baby. A disadvantage of oxytocin is that it requires someone trained and authorized to give an injection. For this reason, oxytocin has so far been generally limited to hospitals and clinics, where it can be administered by medically trained professionals. Another disadvantage is that oxytocin is weakened by heat, which means its storage and use may be impractical in hot countries.
The main aim of this study was therefore to find out whether health workers without midwifery skills are able to administer oxytocin safely when attending home births in poor, rural communities.
What Did the Researchers Do and Find?
The researchers carried out a cluster-randomized controlled trial in four rural districts in Ghana, working with community health officers (CHOs). CHOs are trained for two years in giving childhood immunizations and antenatal and postnatal care, but are not trained midwives. 54 CHOs were randomized to one of two groups. The CHOs in the first group gave a preventative oxytocin injection to the mother at every birth they attended. The oxytocin was administered using a pre-filled, disposable device called Uniject that is easier and quicker to use than a syringe and needle. The packaging also included a heat-sensitive label that indicated whether the oxytocin still met the manufacturer's criteria for an acceptably potent drug. CHOs in the second group acted as controls, and did not give any oxytocin injections to prevent PPH. The women seen by each CHO formed a cluster. Comparisons were made across the clusters of women that either received or did not receive the preventative intervention.
The researchers found that the women who were given a preventative oxytocin injection lost less blood after birth than the women who did not receive a preventative injection. There were also fewer cases of PPH amongst the women who received oxytocin for PPH prevention. 2.6% of the women who received a preventative oxytocin injection experienced PPH, compared to 5.5% of the controls. Therefore the risk of PPH was approximately halved. There were no cases of oxytocin use before delivery of the baby and no difference in the frequency of other birth complications between women in the intervention and control groups.
What Do These Findings Mean?
These findings show that under the trial conditions, CHOs can safely administer oxytocin injections when attending home births in poor, rural settings. This intervention also proved practical to use in the Uniject format.
The study therefore suggests that oxytocin should be considered for use in regions where maternal deaths from PPH are still unacceptably high. There are also several noteworthy limitations, such as unblinding and the imbalance between participant groups. The researchers emphasized that their findings do not mean that oxytocin is always a better choice than misoprostol for home births. Many factors will influence which intervention is the most feasible, such as the local availability of sufficiently skilled health professionals, the relative cost and availability of the two drugs, as well as ease of access to emergency health services.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001524.
This study is further discussed in a PLOS Medicine Perspective by João Paulo Souza
WHO Factsheet on Maternal Mortality
United Nations Population Fund's Goals to improve sexual and reproductive health
doi:10.1371/journal.pmed.1001524
PMCID: PMC3794862  PMID: 24130463
17.  Proactive tobacco cessation outreach to smokers of low socioeconomic status: a randomized clinical trial 
JAMA internal medicine  2015;175(2):218-226.
Importance
Widening socioeconomic disparities in mortality in the United States are largely explained by slower declines in tobacco use between low- and high-socioeconomic status (SES) groups, suggesting the need for targeted tobacco cessation interventions. Documentation of smoking status in electronic health records (EHRs), provides health systems with an opportunity to proactively offer tobacco treatment to disadvantaged smokers.
Objective
To evaluate a proactive strategy to provide tobacco treatment that addresses socio-contextual mediators of tobacco use for low-SES smokers.
Design, Setting, Participants
Prospective, randomized controlled trial for low-SES adult smokers who described their race/ethnicity as black, Hispanic or white and received primary care at one of 13 practices in greater-Boston (intervention n=399, control n=308).
Intervention
We used interactive voice response (IVR)-facilitated outreach to eligible individuals using EHR-coded smoking status. Consenting patients were randomized to a control group which received usual care from their health care team or to an intervention group that included a treatment program of: (1) telephone-based motivational counseling, (2) 6-weeks of free nicotine replacement therapy (NRT), (3) access to community-based referrals to address socio-contextual mediators of tobacco use, and (4) integration of this program with an individual’s care team through the EHR.
Main Outcome
Self-reported past 7-day tobacco abstinence 9-months after randomization (“quitting”), assessed by automated caller or blinded study staff.
Results
The intervention group had a higher quit rate than the usual care group (17.8% vs. 8.1%, odds ratio 2.5, 95% confidence interval 1.5-4.0, number-needed-to-treat=10). We examined whether use of intervention components was associated with quitting among individuals in the intervention group; individuals who participated in the telephone counseling were more likely to quit compared to those who did not (21.2% vs. 10.4%, p=0.0009). There was no difference in quitting by use of NRT. Quitting did not differ by a request for a community referral, but individuals who used their referral were more likely to quit than those who did not (43.6% vs. 15.3%, p<0.0001).
Conclusions and Relevance
Proactive, IVR-facilitated outreach enables engagement with low-SES smokers. Providing counseling, nicotine replacement therapy, and access to community-based resources to address socio-contextual mediators among smokers reached in this setting is effective.
doi:10.1001/jamainternmed.2014.6674
PMCID: PMC4590783  PMID: 25506771
tobacco control; surveillance; health disparities
18.  Keeping Pace With Oral Chemotherapy 
Purpose:
Although the rising number of oral chemotherapy agents offers many patients with cancer a more convenient and less invasive treatment option compared with infusion therapy, multiple risks and challenges have been identified with the oral regimen, including dosing errors, drug interactions, and nonadherence or overadherence. Until recently, cancer care providers had maintained a considerable amount of control, including the certainty that the right drug was being administered in the right dose, via the right route, at the right time, and to the right patient—all of which were meticulously documented in patient records. In contrast, oral chemotherapy takes much of the control out of the clinician's hands and places tremendous responsibility on the patient, raising a number of adherence and control issues. Studies regarding oral hormonal therapy for breast cancer have described adherence rates ramping down from 83% to 77% within the first 2 years of therapy. These figures continue to decrease over time to a range of 50% to 64% within 4 to 5 years. On the basis of these data and a literature review, we developed a program to promote adherence to oral anticancer protocols.
Methods:
Our team took a proactive, team-focused approach and established protocols at a time when oral chemotherapies were still at a low volume. In addition to infrastructures, policies, and procedures promoting collaborative communications among physicians, nurses, and pharmacists, we developed an in-depth educational component that provides the linchpin for ensuring an effective oral chemotherapy program. Our program focuses on three key pillars: education, communication, and follow-up. Our project team first conducted an inclusive review of available literature, with the objective of designing processes that would help our program directly address existing risks and challenges. Then we introduced concepts for the formalized program to our cancer center physicians, whose support was paramount to successful implementation. The next step was to start the program with a mandatory in-service for all clinical staff, which included a presentation of the research evidence that prompted the creation of this model for oral chemotherapy. To enhance patient understanding, our team provides printed materials, individualized calendars, and in some cases preloaded pillboxes to assist patients. Concurrently, our nurses provide weekly telephone intervention for the second and third months and monthly phone interventions thereafter. Communication is key to the success of the program. This includes the use of a translation service to ensure effective communication with all non–English-speaking patients. We intervene early for those patients with financial barriers and offer a variety of referrals and resources for emotional, nutritional, and patient support services, including transportation issues.
Results:
Since the inception of the program, the in-service has been incorporated into our new employee orientation. At the same time, a growing number of cancer center physicians are embracing the program. The program has received the attention of the Oncology Roundtable, which developed a Webinar around the topic, and been described in a feature article in an oncology journal. Finally, our team has been tapped to educate other pharmacists regarding oral agents, toxicity profiles, and safe handling.
Conclusion:
By combining safeguards, patient education strategies, intensive follow-up, and a system of effective checks and balances, our center is taking significant steps to maximize patient safety and oral chemotherapy treatment effectiveness, while keeping pace with the rapidly occurring changes in oncology practice.
doi:10.1200/JOP.2011.000449
PMCID: PMC3457830
19.  NEWHINTS cluster randomised trial to evaluate the impact on neonatal mortality in rural Ghana of routine home visits to provide a package of essential newborn care interventions in the third trimester of pregnancy and the first week of life: trial protocol 
Trials  2010;11:58.
Background
Tackling neonatal mortality is essential for the achievement of the child survival millennium development goal. There are just under 4 million neonatal deaths, accounting for 38% of the 10.8 million deaths among children younger than 5 years of age taking place each year; 99% of these occur in low- and middle-income countries where a large proportion of births take place at home, and where postnatal care for mothers and neonates is either not available or is of poor quality. WHO and UNICEF have issued a joint statement calling for governments to implement "Home visits for the newborn child: a strategy to improve survival", following several studies in South Asia which achieved substantial reductions in neonatal mortality through community-based approaches. However, their feasibility and effectiveness have not yet been evaluated in Africa. The Newhints study aims to do this in Ghana and to develop a feasible and sustainable community-based approach to improve newborn care practices, and by so doing improve neonatal survival.
Methods
Newhints is an integrated intervention package based on extensive formative research, and developed in close collaboration with seven District Health Management Teams (DHMTs) in Brong Ahafo Region. The core component is training the existing community based surveillance volunteers (CBSVs) to identify pregnant women and to conduct two home visits during pregnancy and three in the first week of life to address essential care practices, and to assess and refer very low birth weight and sick babies. CBSVs are supported by a set of materials, regular supervisory visits, incentives, sensitisation activities with TBAs, health facility staff and communities, and providing training for essential newborn care in health facilities.
Newhints is being evaluated through a cluster randomised controlled trial, and intention to treat analyses. The clusters are 98 supervisory zones; 49 have been randomised for implementation of the Newhints intervention, with the other 49 acting as controls. Data on neonatal mortality and care practices will be collected from approximately 15,000 babies through surveillance of women of child-bearing age in the 7 districts. Detailed process, cost and cost-effectiveness evaluations are also being carried out.
Trial registration
http://www.clinicaltrials.gov (identifier NCT00623337)
doi:10.1186/1745-6215-11-58
PMCID: PMC2890650  PMID: 20478070
20.  Conducting the ACTIVE Randomized Trial in Hospice Care: Keys to Success 
Clinical trials (London, England)  2012;10(1):10.1177/1740774512461858.
Background
Untreated pain is common for patients at the end of life. Informal caregivers, often family or friends of patients, are responsible for working with hospice staff to provide pain management. Interdisciplinary team meetings conducted in hospices every two weeks provide an opportunity for hospice staff to communicate about pain management with informal caregivers of hospice patients.
Purpose
We present challenges, solutions, and keys strategies for carrying out a randomized trial in the hospice setting.
Methods
We are conducting the ACTIVE study (Assessing Caregivers for Team Intervention through Video Encounters) to determine whether regular videoconferencing between hospice patients' informal caregivers and the hospice care team alters caregivers' perceptions of pain management and patients' pain. Participants must be primary caregivers for a hospice patient, at least 18 years of age, capable of providing informed consent, and have access to a computer with a high-speed Internet connection or a telephone. We randomized caregivers to participate in biweekly team meetings through video or phone conferencing (intervention) or to receive usual care from the hospice. All patients receive standard hospice care regardless of the group assignment of their informal caregiver.
Results
As of July 1, 2012, there has been 1038 new admissions to the participating hospices. Of 391 cases in which no contact was made, 233 patients had died or had life expectancy less than 14 days. Home visits were made to 271 interested and eligible caregivers; 249 caregivers of 233 patients were randomly assigned to the usual care or intervention arm. Enrollment is on pace to meet recruitment goals.
Lessons Learned
Thorough pilot-testing of instruments and procedures helped us overcome barriers to conducting research in this vulnerable population. Keys to success included obtaining support from hospice medical directors, including hospice staff in study preparation, minimizing the burden on hospice staff, housing research staff in each participating hospice, using newsletters to enhance communication, developing and maintaining a detailed procedural manual, producing regular data quality reports, developing a secure site to facilitate coding videos for qualitative studies, and holding regular teleconferences with key staff.
Limitations
Late enrollment of many patients in hospice left little to no time for their caregivers to take part in the intervention. Assisting caregivers of patients with very short life expectancy may require different methods.
Conclusions
The challenges of conducting randomized trials with hospice patients and caregivers can be addressed with appropriate study design, well-tested research methods, and proactive monitoring of any issues or problems.
doi:10.1177/1740774512461858
PMCID: PMC3554844  PMID: 23104974
hospice; randomized trial; pain management; videoconference; caregivers; interdisciplinary teams
21.  Effect of Facilitation of Local Maternal-and-Newborn Stakeholder Groups on Neonatal Mortality: Cluster-Randomized Controlled Trial 
PLoS Medicine  2013;10(5):e1001445.
Lars Åke Persson and colleagues conduct a cluster randomised control in northern Vietnam to analyze the effect of the activity of local community-based maternal-and-newborn stakeholder groups on neonatal mortality.
Please see later in the article for the Editors' Summary
Background
Facilitation of local women's groups may reportedly reduce neonatal mortality. It is not known whether facilitation of groups composed of local health care staff and politicians can improve perinatal outcomes. We hypothesised that facilitation of local stakeholder groups would reduce neonatal mortality (primary outcome) and improve maternal, delivery, and newborn care indicators (secondary outcomes) in Quang Ninh province, Vietnam.
Methods and Findings
In a cluster-randomized design 44 communes were allocated to intervention and 46 to control. Laywomen facilitated monthly meetings during 3 years in groups composed of health care staff and key persons in the communes. A problem-solving approach was employed. Births and neonatal deaths were monitored, and interviews were performed in households of neonatal deaths and of randomly selected surviving infants. A latent period before effect is expected in this type of intervention, but this timeframe was not pre-specified. Neonatal mortality rate (NMR) from July 2008 to June 2011 was 16.5/1,000 (195 deaths per 11,818 live births) in the intervention communes and 18.4/1,000 (194 per 10,559 live births) in control communes (adjusted odds ratio [OR] 0.96 [95% CI 0.73–1.25]). There was a significant downward time trend of NMR in intervention communes (p = 0.003) but not in control communes (p = 0.184). No significant difference in NMR was observed during the first two years (July 2008 to June 2010) while the third year (July 2010 to June 2011) had significantly lower NMR in intervention arm: adjusted OR 0.51 (95% CI 0.30–0.89). Women in intervention communes more frequently attended antenatal care (adjusted OR 2.27 [95% CI 1.07–4.8]).
Conclusions
A randomized facilitation intervention with local stakeholder groups composed of primary care staff and local politicians working for three years with a perinatal problem-solving approach resulted in increased attendance to antenatal care and reduced neonatal mortality after a latent period.
Trial registration
Current Controlled Trials ISRCTN44599712
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Over the past few years, there has been enormous international effort to meet the target set by Millennium Development Goal 4 to reduce the under-five child mortality rate by two-thirds and to reduce the number of maternal deaths by three-quarters, respectively, from the 1990 level by 2015. There has been some encouraging progress and according to the latest figures from the World Health Organization, in 2011, just under 7 million children aged under 5 years died, a fall of almost 3 million from a decade ago. However, currently, 41% of all deaths among children under the age of 5 years occur around birth and the first 28 days of life (perinatal and neonatal mortality). Simple interventions can substantially reduce neonatal deaths and there have been several international, national, and local efforts to implement effective care packages to help reduce the number of neonatal deaths.
Why Was This Study Done?
In order for these interventions to be most effective, it is important that the local community becomes involved. Community mobilization, especially through local women's groups, can empower women to prioritize specific interventions to help improve their own health and that of their baby. An alternative strategy might be to mobilize people who already have responsibility to promote health and welfare in society, such as primary care staff, village health workers, and elected political representatives. However, it is unclear if the activities of such stakeholder groups result in improved neonatal survival. So in this study from northern Vietnam, the researchers analyzed the effect of the activity of local maternal-and-newborn stakeholder groups on neonatal mortality.
What Did the Researchers Do and Find?
Between 2008 and 2011, the researchers conducted a cluster-randomized controlled trial in 90 communes within the Quang Ninh province of northeast of Vietnam: 44 communes were allocated to intervention and 46 to the control. The local women's union facilitated recruitment to the intervention, local stakeholder groups (Maternal and Newborn Health Groups), which comprised primary care staff, village health workers, women's union representatives, and the person with responsibility for health in the commune. The groups' role was to identify and prioritize local perinatal health problems and implement actions to help overcome these problems.
Over the three-year period, the Maternal and Newborn Health Groups in the 44 intervention communes had 1,508 meetings. Every year 15–27 unique problems were identified and addressed 94–151 times. The problem-solving processes resulted in an annual number of 19–27 unique actions that were applied 297–649 times per year. The top priority problems and actions identified by these groups dealt with antenatal care attendance, post-natal visits, nutrition and rest during pregnancy, home deliveries, and breast feeding. Neonatal mortality in the intervention group did not change over the first two years but showed a significant improvement in the third year. The three leading causes of death were prematurity/low birth-weight (36%), intrapartum-related neonatal deaths (30%), and infections (15%). Stillbirth rates were 7.4 per 1,000 births in the intervention arm and 9.0 per 1,000 births in the control arm. There was one maternal death in the intervention communes and four in the control communes and there was a significant improvement in antenatal care attendance in the intervention arm. However, there were no significant differences between the intervention and control groups of other outcomes, including tetanus immunization, delivery preparedness, institutional delivery, temperature control at delivery, early initiation of breastfeeding, or home visit of a midwife during the first week after delivery.
What Do These Findings Mean?
These findings suggest that local stakeholder groups comprised of primary care staff and local politicians using a problem-solving approach may help to reduce the neonatal mortality rate after three years of implementation (although the time period for an expected reduction in neonatal mortality was not specified before the trial started) and may also increase the rate of antenatal care attendance. However, the intervention had no effect on other important outcomes such as the rate of institutional delivery and breast feeding. This study used a novel approach of community-based activity that was implemented into the public sector system at low cost. A further reduction in neonatal deaths around delivery might be achieved by neonatal resuscitation training and home visits to the mother and her baby.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001445.
The World Health Organization provides comprehensive statistics on neonatal mortality
The Healthy Newborn Network has information on community interventions to help reduce neonatal mortality from around the world
doi:10.1371/journal.pmed.1001445
PMCID: PMC3653802  PMID: 23690755
22.  A nurse- and peer-led support program to assist women in gynaecological oncology receiving curative radiotherapy, the PeNTAGOn study (Peer and nurse support trial to assist women in gynaecological oncology): study protocol for a randomised controlled trial 
Trials  2013;14:39.
Background
Women who undergo radiotherapy for gynaecological cancer (GC) can experience distressing side effects which impact on psychosocial functioning and intimate relationships. Cancer-related distress may be ameliorated by comprehensive preparation for treatment and addressing women’s informational, physical, psychological and psychosexual needs. This paper describes the protocol for a multisite randomised controlled trial (RCT) testing a novel intervention package which combines tailored specialist nursing consultations and telephone peer support with the primary aim to reduce psychological distress. Secondary aims assess patient quality of life, symptom distress, unmet supportive care needs, preparation for treatment, psychosexual functioning and vaginal stenosis.
Methods/design
This multifaceted intervention comprises four nurse-led consultations coupled with four phone calls from a peer support volunteer (GC survivor). The evidence-based intervention will be delivered at critical points in the illness trajectory: pre-treatment, mid-treatment, treatment completion and post-treatment. Nurses and peers undergo 2-day intensive training workshops, are guided by comprehensive study intervention manuals and receive ongoing supervision and support. Eligible patients will have a diagnosis of GC, be scheduled to receive curative radiotherapy, be aged 18 years or over and speak English. Three-hundred and six participants will be randomized to receive usual care or usual care with the intervention package. Study outcome measures will be collected at baseline, day 1 of radiotherapy and 1, 6 and 12 months post radiotherapy. Clinical assessments of vaginal toxicity will occur at baseline, and 3, 6, and 12 months post radiotherapy.
Discussion
This timely research has the potential to substantially reduce the physical, psychosexual and supportive care needs of women with GC. Using a telephone peer support model, the intervention package ensures equitable access to support services for geographically isolated patients. The novel intervention engages peer volunteers who liaise with nurses to encourage adherence to professionally-delivered information and provide emotional support. It has been designed to be potentially transferable to a range of treatment settings and diseases. Based on pilot data, the proposed intervention was found to be useful and acceptable to patients and clinicians. If effective and feasible in the multisite RCT, the program could be widely disseminated.
Trial registration
Australian New Zealand Clinical Trial Registry ACTRN12611000744954
doi:10.1186/1745-6215-14-39
PMCID: PMC3576284  PMID: 23399476
Peer support; Nurse; Intervention; RCT; Gynaecological cancer; Radiotherapy; Distress; Quality of life; Psychosexual function
23.  Evaluation of Lay Support in Pregnant women with Social risk (ELSIPS): a randomised controlled trial 
Background
Maternal, neonatal and child health outcomes are worse in families from black and ethnic minority groups and disadvantaged backgrounds. There is little evidence on whether lay support improves maternal and infant outcomes among women with complex social needs within a disadvantaged multi-ethnic population in the United Kingdom (UK).
Method/Design
The aim of this study is to evaluate a lay Pregnancy Outreach Worker (POW) service for nulliparous women identified as having social risk within a maternity service that is systematically assessing social risks alongside the usual obstetric and medical risks. The study design is a randomised controlled trial (RCT) in nulliparous women assessed as having social risk comparing standard maternity care with the addition of referral to the POW support service.
The POWs work alongside community midwifery teams and offer individualised support to women to encourage engagement with services (health and social care) from randomisation (before 28 weeks gestation) until 6 weeks after birth.
The primary outcomes have been chosen on the basis that they are linked to maternal and infant health. The two primary outcomes are engagement with antenatal care, assessed by the number of antenatal visits; and maternal depression, assessed using the Edinburgh Postnatal Depression Scale at 8-12 weeks after birth. Secondary outcomes include maternal and neonatal morbidity and mortality, routine child health assessments, including immunisation uptake and breastfeeding at 6 weeks. Other psychological outcomes (self efficacy) and mother-to-infant bonding will also be collected using validated tools.
A sample size of 1316 will provide 90% power (at the 5% significance level) to detect increased engagement with antenatal services of 1.5 visits and a reduction of 1.5 in the average EPDS score for women with two or more social risk factors, with power in excess of this for women with any social risk factor. Analysis will be by intention to treat.
Qualitative research will explore the POWs' daily work in context. This will complement the findings of the RCT through a triangulation of quantitative and qualitative data on the process of the intervention, and identify other contextual factors that affect the implementation of the intervention.
Discussion
The trial will provide high quality evidence as to whether or not lay support (POW) offered to women identified with social risk factors improves engagement with maternity services and reduces numbers of women with depression.
MREC number
10/H1207/23
Trial registration number
ISRCTN: ISRCTN35027323
doi:10.1186/1471-2393-12-11
PMCID: PMC3349581  PMID: 22375895
24.  Randomised controlled trial of support from volunteer counsellors for mothers considering breast feeding 
BMJ : British Medical Journal  2004;328(7430):26.
Objective To investigate whether offering volunteer support from counsellors in breast feeding would result in more women breast feeding.
Design Randomised controlled trial.
Setting 32 general practices in London and south Essex.
Participants 720 women considering breast feeding.
Main outcome measures Primary outcome was prevalence of any breast feeding at six weeks. Secondary outcomes were the proportion of women giving any breast feeds, or bottle feeds at four months, duration of any breast feeding, time to introduction of bottle feeds, and satisfaction with breast feeding.
Results Offering support in breast feeding did not significantly increase the prevalence of any breast feeding to six weeks (65% (218/336) in the intervention group and 63% (213/336) in the control group; relative risk 1.02, 95% confidence interval 0.84 to 1.24). Survival analysis up to four months confirmed that neither duration of breast feeding nor time to introduction of formula feeds differed significantly between control and intervention groups. Not all women in the intervention group contacted counsellors postnatally, but 73% (123/179) of those who did rated them as very helpful. More women in the intervention group than in the control group said that their most helpful advice came from counsellors rather than from other sources.
Conclusions Women valued the support of a counsellor in breast feeding, but the intervention did not significantly increase breastfeeding rates, perhaps because some women did not ask for help.
PMCID: PMC313903  PMID: 14703543
25.  Community Mobilization in Mumbai Slums to Improve Perinatal Care and Outcomes: A Cluster Randomized Controlled Trial 
PLoS Medicine  2012;9(7):e1001257.
David Osrin and colleagues report findings from a cluster-randomized trial conducted in Mumbai slums; the trial aimed to evaluate whether facilitator-supported women's groups could improve perinatal outcomes.
Introduction
Improving maternal and newborn health in low-income settings requires both health service and community action. Previous community initiatives have been predominantly rural, but India is urbanizing. While working to improve health service quality, we tested an intervention in which urban slum-dweller women's groups worked to improve local perinatal health.
Methods and Findings
A cluster randomized controlled trial in 24 intervention and 24 control settlements covered a population of 283,000. In each intervention cluster, a facilitator supported women's groups through an action learning cycle in which they discussed perinatal experiences, improved their knowledge, and took local action. We monitored births, stillbirths, and neonatal deaths, and interviewed mothers at 6 weeks postpartum. The primary outcomes described perinatal care, maternal morbidity, and extended perinatal mortality. The analysis included 18,197 births over 3 years from 2006 to 2009. We found no differences between trial arms in uptake of antenatal care, reported work, rest, and diet in later pregnancy, institutional delivery, early and exclusive breastfeeding, or care-seeking. The stillbirth rate was non-significantly lower in the intervention arm (odds ratio 0.86, 95% CI 0.60–1.22), and the neonatal mortality rate higher (1.48, 1.06–2.08). The extended perinatal mortality rate did not differ between arms (1.19, 0.90–1.57). We have no evidence that these differences could be explained by the intervention.
Conclusions
Facilitating urban community groups was feasible, and there was evidence of behaviour change, but we did not see population-level effects on health care or mortality. In cities with multiple sources of health care, but inequitable access to services, community mobilization should be integrated with attempts to deliver services for the poorest and most vulnerable, and with initiatives to improve quality of care in both public and private sectors.
Trial registration
Current Controlled Trials ISRCTN96256793
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Substantial progress is being made to reduce global child mortality (deaths of children before the age of 5 years) and maternal mortality (deaths among women because of complications of pregnancy and childbirth)—two of the Millennium Development Goals agreed by world leaders in 2000 to end extreme poverty. Even so, worldwide, in 2010, 7.6 million children died before their fifth birthday and there were nearly 360,000 maternal deaths. Almost all child and maternal deaths occur in developing countries—a fifth of under-five deaths and more than a quarter of neonatal deaths (deaths during the first month of life, which account for two-fifths of all child deaths) occur in India alone. Moreover, most child and maternal deaths are caused by avoidable conditions. Specifically, the major causes of neonatal death—complications of preterm delivery, breathing problems during or after delivery, and infections of the blood (sepsis) and lungs (pneumonia)—and of maternal deaths—hemorrhage (abnormal bleeding), sepsis, unsafe abortion, obstructed labor, and hypertensive diseases of pregnancy—could all be largely prevented by improved access to reproductive health services and skilled health care workers.
Why Was This Study Done?
Experts believe that improvements to maternal and newborn health in low-income settings require both health service strengthening and community action. That is, the demand for better services, driven by improved knowledge about maternal and newborn health (perinatal issues), has to be increased in parallel with the supply of those services. To date, community mobilization around perinatal issues has largely been undertaken in rural settings but populations in developing countries are becoming increasingly urban. In India, for example, 30% of the population now lives in cities. In this cluster randomized controlled trial (a study in which groups of people are randomly assigned to receive alternative interventions and the outcomes in the differently treated “clusters” are compared), City Initiative for Newborn Health (CINH) researchers investigate the effect of an intervention designed to help women's groups in the slums of Mumbai work towards improving local perinatal health. The CINH aims to improve maternal and newborn health in slum communities by improving public health care provision and by working with community members to improve maternal and newborn care practices and care-seeking behaviors.
What Did the Researchers Do and Find?
The researchers enrolled 48 Mumbai slum communities of at least 1,000 households into their trial. In each of the 24 intervention clusters, a facilitator supported local women's groups through a 36-meeting learning cycle during which group members discussed their perinatal experiences, improved their knowledge, and took action. To measure the effect of the intervention, the researchers monitored births, stillbirths, and neonatal deaths in all the clusters and interviewed mothers 6 weeks after delivery. During the 3-year trial, there were 18,197 births in the participating settlements. The women in the intervention clusters were enthusiastic about acquiring new knowledge and made substantial efforts to reach out to other women but were less successful in undertaking collective action such as negotiations with civic authorities for more amenities. There were no differences between the intervention and control communities in the uptake of antenatal care, reported work, rest, and diet in late pregnancy, institutional delivery, or in breast feeding and care-seeking behavior. Finally, the combined rate of stillbirths and neonatal deaths (the extended perinatal mortality rate) was the same in both arms of the trial, as was maternal mortality.
What Do These Findings Mean?
These findings indicate that it is possible to facilitate the discussion of perinatal health care by urban women's groups in the challenging conditions that exist in the slums of Mumbai. However, they fail to show any measureable effect of community mobilization through the facilitation of women's groups on perinatal health at the population level. The researchers acknowledge that more intensive community activities that target the poorest, most vulnerable slum dwellers might produce measurable effects on perinatal mortality, and they conclude that, in cities with multiple sources of health care and inequitable access to services, it remains important to integrate community mobilization with attempts to deliver services to the poorest and most vulnerable, and with initiatives to improve the quality of health care in both the public and private sector.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001257.
The United Nations Childrens Fund (UNICEF) works for children's rights, survival, development, and protection around the world; it provides information on the reduction of child mortality (Millennium Development Goal 4); its Childinfo website provides information about all the Millennium Development Goals and detailed statistics about on child survival and health, newborn care, and maternal health (some information in several languages)
The World Health Organization also has information about Millennium Development Goal 4 and Millennium Development Goal 5, the reduction of maternal mortality, provides information on newborn infants, and provides estimates of child mortality rates (some information in several languages)
Further information about the Millennium Development Goals is available
Information on the City Initiative for Newborn Health and its partners and a detailed description of its trial of community mobilization in Mumbai slums to improve care during pregnancy, delivery, postnatally and for the newborn are available
Further information about the Society for Nutrition, Education and Health Action (SNEHA) is available
doi:10.1371/journal.pmed.1001257
PMCID: PMC3389036  PMID: 22802737

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