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Background

Progress on neonatal survival has been slow in most countries. While there is evidence on what works to reduce newborn mortality, there is limited knowledge on how to deliver interventions effectively when health systems are weak. Cluster randomized trials have shown strong reductions in neonatal mortality using community mobilisation with women's groups in rural Nepal and India. A similar trial in Bangladesh showed no impact. A main hypothesis is that this negative finding is due to the much lower coverage of women's groups in the intervention population in Bangladesh compared to India and Nepal. For evidence-based policy making it is important to examine if women's group coverage is a main determinant of their impact. The study aims to test the effect on newborn and maternal health outcomes of a participatory women's group intervention with a high population coverage of women's groups.

Methods

A cluster randomised trial of a participatory women's group intervention will be conducted in 3 districts of rural Bangladesh. As we aim to study a women's group intervention with high population coverage, the same 9 intervention and 9 control unions will be used as in the 2005-2007 trial. These had been randomly allocated using the districts as strata. To increase coverage, 648 new groups were formed in addition to the 162 existing groups that were part of the previous trial. An open cohort of women who are permanent residents in the union in which their delivery or death was identified, is enrolled. Women and their newborns are included after birth, or, if a woman dies during pregnancy, after her death. Excluded are women who are temporary residents in the union in which their birth or death was identified. The primary outcome is neonatal mortality in the last 24 months of the study. A low cost surveillance system will be used to record all birth outcomes and deaths to women of reproductive age in the study population. Data on home care practices and health care use are collected through interviews.

Trial registration

ISRCTN: ISRCTN01805825

Background

Neonatal mortality rates are high in rural Nepal where more than 90% of deliveries are in the home. Evidence suggests that death rates can be reduced by interventions at community level. We describe an intervention which aimed to harness the power of community planning and decision making to improve maternal and newborn care in rural Nepal.

Methods

The development of 111 women's groups in a population of 86 704 in Makwanpur district, Nepal is described. The groups, facilitated by local women, were the intervention component of a randomized controlled trial to reduce perinatal and neonatal mortality rates. Through participant observation and analysis of reports, we describe the implementation of this intervention: the community entry process, the facilitation of monthly meetings through a participatory action cycle of problem identification, community planning, and implementation and evaluation of strategies to tackle the identified problems.

Results

In response to the needs of the group, participatory health education was added to the intervention and the women's groups developed varied strategies to tackle problems of maternal and newborn care: establishing mother and child health funds, producing clean home delivery kits and operating stretcher schemes. Close linkages with community leaders and community health workers improved strategy implementation. There were also indications of positive effects on group members and health services, and most groups remained active after 30 months.

Conclusion

A large scale and potentially sustainable participatory intervention with women's groups, which focused on pregnancy, childbirth and the newborn period, resulted in innovative strategies identified by local communities to tackle perinatal care problems.

Background

Neonatal mortality remains high in rural Nepal. Previous work suggests that local women's groups can effect significant improvement through community mobilisation. The possibility of identification and management of newborn infections by community-based workers has also arisen.

Methods/Design

The objective of this trial is to evaluate the effects on newborn health of two community-based interventions involving Female Community Health Volunteers.

MIRA Dhanusha community groups: a participatory intervention with women's groups. MIRA Dhanusha sepsis management: training of community volunteers in the recognition and management of neonatal sepsis.

The study design is a cluster randomized controlled trial involving 60 village development committee clusters allocated 1:1 to two interventions in a factorial design.

MIRA Dhanusha community groups: Female Community Health Volunteers (FCHVs) are supported in convening monthly women's groups. Nine groups per cluster (270 in total) work through two action research cycles in which they (i) identify local issues around maternity, newborn health and nutrition, (ii) prioritise key problems, (iii) develop strategies to address them, (iv) implement the strategies, and (v) evaluate their success. Cycle 1 focuses on maternal and newborn health and cycle 2 on nutrition in pregnancy and infancy and associated postpartum care practices.

MIRA Dhanusha sepsis management: FCHVs are trained to care for vulnerable newborn infants. They (i) identify local births, (ii) identify low birth weight infants, (iii) identify possible newborn infection, (iv) manage the process of treatment with oral antibiotics and referral to a health facility to receive parenteral gentamicin, and (v) follow up infants and support families.

Primary outcome: neonatal mortality rates. Secondary outcomes: MIRA Dhanusha community group: stillbirth, infant and under-two mortality rates, care practices and health care seeking behaviour, maternal diet, breastfeeding and complementary feeding practices, maternal and under-2 anthropometric status. MIRA Dhanusha sepsis management: identification and treatment of neonatal sepsis by community health volunteers, infection-specific neonatal mortality.

Trial Registration no

ISRCTN: ISRCTN87820538

Objective

To assess the impact on mortality related to pregnancy of supplementing women of reproductive age each week with a recommended dietary allowance of vitamin A, either preformed or as β carotene.

Design

Double blind, cluster randomised, placebo controlled field trial.

Setting

Rural southeast central plains of Nepal (Sarlahi district).

Subjects

44 646 married women, of whom 20 119 became pregnant 22 189 times.

Intervention

270 wards randomised to 3 groups of 90 each for women to receive weekly a single oral supplement of placebo, vitamin A (7000 μg retinol equivalents) or β carotene (42 mg, or 7000 μg retinol equivalents) for over 3½ years.

Main outcome measures

All cause mortality in women during pregnancy up to 12 weeks post partum (pregnancy related mortality) and mortality during pregnancy to 6 weeks postpartum, excluding deaths apparently related to injury (maternal mortality).

Results

Mortality related to pregnancy in the placebo, vitamin A, and β carotene groups was 704, 426, and 361 deaths per 100 000 pregnancies, yielding relative risks (95% confidence intervals) of 0.60 (0.37 to 0.97) and 0.51 (0.30 to 0.86). This represented reductions of 40% (P<0.04) and 49% (P<0.01) among those who received vitamin A and β carotene. Combined, vitamin A or β carotene lowered mortality by 44% (0.56 (0.37 to 0.84), P<0.005) and reduced the maternal mortality ratio from 645 to 385 deaths per 100 000 live births, or by 40% (P<0.02). Differences in cause of death could not be reliably distinguished between supplemented and placebo groups.

Conclusion

Supplementation of women with either vitamin A or β carotene at recommended dietary amounts during childbearing years can lower mortality related to pregnancy in rural, undernourished populations of south Asia.

Key messagesMaternal vitamin A deficiency, evident as night blindness or low serum retinol concentration during pregnancy, is widely prevalent in rural south AsiaIn Nepal, women of reproductive age who were given 7000 μg retinol equivalents of vitamin A on a weekly basis showed a reduction in mortality related to pregnancy of 40%Weekly dosing with 42 mg β carotene (also providing 7000 μg retinol equivalents) lowered their mortality by 49%Preventing maternal vitamin A deficiency in rural South Asia can lower the risk of mortality of women during and after pregnancy

The birth-preparedness package (BPP) promotes active preparation and decision-making for births, including pregnancy/postpartum periods, by pregnant women and their families. This paper describes a district-wide field trial of the BPP implemented through the government health system in Siraha, Nepal, during 2003–2004. The aim of the field trial was to determine the effectiveness of the BPP to positively influence planning for births, household-level behaviours that affect the health of pregnant and postpartum women and their newborns, and their use of selected health services for maternal and newborn care. Community health workers promoted desired behaviours through inter-personal counselling with individuals and groups. Content of messages included maternal and newborn-danger signs and encouraged the use of healthcare services and preparation for emergencies. Thirty-cluster baseline and endline household surveys of mothers of infants aged less than one year were used for estimating the change in key outcome indicators. Fifty-four percent of respondents (n=162) were directly exposed to BPP materials while pregnant. A composite index of seven indicators that measure knowledge of respondents, use of health services, and preparation for emergencies increased from 33% at baseline to 54% at endline (p=0.001). Five key newborn practices increased by 19 to 29 percentage points from baseline to endline (p values ranged from 0.000 to 0.06). Certain key maternal health indicators, such as skilled birth attendance and use of emergency obstetric care, did not change. The BPP can positively influence knowledge and intermediate health outcomes, such as household practices and use of some health services. The BPP can be implemented by government health services with minimal outside assistance but should be comprehensively integrated into the safe motherhood programme rather than implemented as a separate intervention.

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

Background

To evaluate a delivery strategy for newborn interventions in rural Bangladesh.

Methods

A cluster-randomized controlled trial was conducted in Mirzapur, Bangladesh. Twelve unions were randomized to intervention or comparison arm. All women of reproductive age were eligible to participate. In the intervention arm, community health workers identified pregnant women; made two antenatal home visits to promote birth and newborn care preparedness; made four postnatal home visits to negotiate preventive care practices and to assess newborns for illness; and referred sick neonates to a hospital and facilitated compliance. Primary outcome measures were antenatal and immediate newborn care behaviours, knowledge of danger signs, care seeking for neonatal complications, and neonatal mortality.

Findings

A total of 4616 and 5241 live births were recorded from 9987 and 11153 participants in the intervention and comparison arm, respectively. High coverage of antenatal (91% visited twice) and postnatal (69% visited on days 0 or 1) home visitations was achieved. Indicators of care practices and knowledge of maternal and neonatal danger signs improved. Adjusted mortality hazard ratio in the intervention arm, compared to the comparison arm, was 1.02 (95% CI: 0.80–1.30) at baseline and 0.87 (95% CI: 0.68–1.12) at endline. Primary causes of death were birth asphyxia (49%) and prematurity (26%). No adverse events associated with interventions were reported.

Conclusion

Lack of evidence for mortality impact despite high program coverage and quality assurance of implementation, and improvements in targeted newborn care practices suggests the intervention did not adequately address risk factors for mortality. The level and cause-structure of neonatal mortality in the local population must be considered in developing interventions. Programs must ensure skilled care during childbirth, including management of birth asphyxia and prematurity, and curative postnatal care during the first two days of life, in addition to essential newborn care and infection prevention and management.

Trial Registration

Clinicaltrials.gov NCT00198627

Background

To study maternal anxiety and perinatal outcomes in pregnant women submitted to a Multidisciplinary Program for Childbirth and Motherhood Preparation (MPCM).

Methods

This is a not randomized controlled trial on 67 nulliparous pregnant women divided into two groups according to participation (MPCM Group; n = 38) or not (Control Group; n = 29) in MPCM. The program consisted of 10 meetings (between the 18th and the 38th gestational week) during which educational, physiotherapeutic and interaction activities were developed. Anxiety was quantified at the beginning and at the end of the gestational period by the Trace-State Anxiety Inventory (STAI).

Results

Initial maternal anxiety was equivalent between the groups. At the end of the gestational period, it was observed that anxiety levels increased in the Control Group and were maintained in the MPCM Group. A higher occurrence of vaginal deliveries (83.8%) and hospital discharge of three-day-older newborns (81.6%) as a result of MPCM was also significant. Levels of state-anxiety at the end of pregnancy showed a negative correlation with vaginal delivery, gestational age, birth weight and Apgar index at the first minute and positive correlation with the hospital period remaining of the newborns.

Conclusion

In the study conditions, MPCM was associated with lower levels of maternal anxiety, a larger number of vaginal deliveries and shorter hospitalization time of newborns. It was not related to adverse perinatal outcomes.

Background

Birth attendance by trained health workers is low in rural Nepal. Local participation in improving health services and increased interaction between health systems and communities may stimulate demand for health services. Significant increases in birth attendance by trained health workers may be affected through community mobilisation by local women's groups and health management committee strengthening. We will test the effect of community mobilisation through women's groups, and health management committee strengthening, on institutional deliveries and home deliveries attended by trained health workers in Makwanpur District.

Design

Cluster randomised controlled trial involving 43 village development committee clusters. 21 clusters will receive the intervention and 22 clusters will serve as control areas. In intervention areas, Female Community Health Volunteers are supported in convening monthly women's groups. The groups work through an action research cycle in which they consider barriers to institutional delivery, plan and implement strategies to address these barriers with their communities, and evaluate their progress. Health management committees participate in three-day workshops that use appreciative inquiry methods to explore and plan ways to improve maternal and newborn health services. Follow-up meetings are conducted every three months to review progress. Primary outcomes are institutional deliveries and home deliveries conducted by trained health workers. Secondary outcome measures include uptake of antenatal and postnatal care, neonatal mortality and stillbirth rates, and maternal morbidity.

Trial registration number

ISRCTN99834806

Background

Around a quarter of the world's neonatal and maternal deaths occur in India. Morbidity and mortality are highest in rural areas and among the poorest wealth quintiles. Few interventions to improve maternal and newborn health outcomes with government-mandated community health workers have been rigorously evaluated at scale in this setting.

The study aims to assess the impact of a community mobilisation intervention with women's groups facilitated by ASHAs to improve maternal and newborn health outcomes among rural tribal communities of Jharkhand and Orissa.

Methods/design

The study is a cluster-randomised controlled trial and will be implemented in five districts, three in Jharkhand and two in Orissa. The unit of randomisation is a rural cluster of approximately 5000 population. We identified villages within rural, tribal areas of five districts, approached them for participation in the study and enrolled them into 30 clusters, with approximately 10 ASHAs per cluster. Within each district, 6 clusters were randomly allocated to receive the community intervention or to the control group, resulting in 15 intervention and 15 control clusters. Randomisation was carried out in the presence of local stakeholders who selected the cluster numbers and allocated them to intervention or control using a pre-generated random number sequence. The intervention is a participatory learning and action cycle where ASHAs support community women's groups through a four-phase process in which they identify and prioritise local maternal and newborn health problems, implement strategies to address these and evaluate the result. The cycle is designed to fit with the ASHAs' mandate to mobilise communities for health and to complement their other tasks, including increasing institutional delivery rates and providing home visits to mothers and newborns. The trial's primary endpoint is neonatal mortality during 24 months of intervention. Additional endpoints include home care practices and health care-seeking in the antenatal, delivery and postnatal period. The impact of the intervention will be measured through a prospective surveillance system implemented by the project team, through which mothers will be interviewed around six weeks after delivery. Cost data and qualitative data are collected for cost-effectiveness and process evaluations.

Study registration

ISRCTN: ISRCTN31567106

Background

Maternal, perinatal and neonatal mortality rates remain high in rural areas of developing countries. Most deliveries take place at home and care-seeking behaviour is often delayed. We report on a combined quantitative and qualitative study of care seeking obstacles and practices relating to perinatal illness in rural Makwanpur district, Nepal, with particular emphasis on consultation strategies.

Methods

The analysis included a survey of 8798 women who reported a birth in the previous two years [of whom 3557 reported illness in their pregnancy], on 30 case studies of perinatal morbidity and mortality, and on 43 focus group discussions with mothers, other family members and health workers.

Results

Early pregnancy was often concealed, preparation for birth was minimal and trained attendance at birth was uncommon. Family members were favoured attendants, particularly mothers-in-law. The most common recalled maternal complications were prolonged labour, postpartum haemorrhage and retained placenta. Neonatal death, though less definable, was often associated with cessation of suckling and shortness of breath. Many home-based care practices for maternal and neonatal illness were described. Self-medication was common.

There were delays in recognising and acting on danger signs, and in seeking care beyond the household, in which the cultural requirement for maternal seclusion, and the perceived expense of care, played a part. Of the 760 women who sought care at a government facility, 70% took more than 12 hours from the decision to seek help to actual consultation. Consultation was primarily with traditional healers, who were key actors in the ascription of causation. Use of the government primary health care system was limited: the most common source of allopathic care was the district hospital.

Conclusions

Major obstacles to seeking care were: a limited capacity to recognise danger signs; the need to watch and wait; and an overwhelming preference to treat illness within the community. Safer motherhood and newborn care programmes in rural communities, must address both community and health facility care to have an impact on morbidity and mortality. The roles of community actors such as mothers-in-law, husbands, local healers and pharmacies, and increased access to properly trained birth attendants need to be addressed if delays in reaching health facilities are to be shortened.

Objective

To assess the impact on birth size and risk of low birth weight of alternative combinations of micronutrients given to pregnant women.

Design

Double blind cluster randomised controlled trial.

Setting

Rural community in south eastern Nepal.

Participants

4926 pregnant women and 4130 live born infants.

Interventions

426 communities were randomised to five regimens in which pregnant women received daily supplements of folic acid, folic acid-iron, folic acid-iron-zinc, or multiple micronutrients all given with vitamin A, or vitamin A alone (control).

Main outcome measures

Birth weight, length, and head and chest circumference assessed within 72 hours of birth. Low birth weight was defined <2500 g.

Results

Supplementation with maternal folic acid alone had no effect on birth size. Folic acid-iron increased mean birth weight by 37 g (95% confidence interval −16 g to 90 g) and reduced the percentage of low birthweight babies (<2500 g) from 43% to 34% (16%; relative risk=0.84, 0.72 to 0.99). Folic acid-iron-zinc had no effect on birth size compared with controls. Multiple micronutrient supplementation increased birth weight by 64 g (12 g to 115 g) and reduced the percentage of low birthweight babies by 14% (0.86, 0.74 to 0.99). None of the supplement combinations reduced the incidence of preterm births. Folic acid-iron and multiple micronutrients increased head and chest circumference of babies, but not length.

Conclusions

Antenatal folic acid-iron supplements modestly reduce the risk of low birth weight. Multiple micronutrients confer no additional benefit over folic acid-iron in reducing this risk.

What is already known on this topicDeficiencies in micronutrients are common in women in developing countries and have been associated with low birth weight and preterm deliveryWhat this study addsIn rural Nepal maternal supplementation with folic acid-iron reduced the incidence of low birth weight by 16%A multiple micronutrient supplement of 14 micronutrients, including folic acid, iron, and zinc, reduced low birth weight by 14%, thus conferring no advantage over folic acid-iron

BACKGROUND:

Fetal diagnosis and intervention are changing the nature and natural history of many congenital anomalies treated today. Given the small cohort numbers and complexity of many congenital anomalies, an integrated network of accurate and timely information sharing is essential for evidence-based best clinical practice and outcomes.

METHODS:

A prospective, population-based, real-time provincial database was established by a transdisciplinary team of antenatal care providers consisting of five perinatal centres and affiliated paediatric subspecialties providing care.

RESULTS:

Eight hundred thirty-two pregnant women referred for fetal anomalies were registered between April 2, 2005, and March 31, 2006. The women had a mean ± SD age of 30±6.2 years, and approximately 90% of the pregnancies were spontaneously conceived. In addition, more than 90% of the women had no predisposing genetic history. The mean time of initial diagnosis was 21 weeks gestational age, and the mean time of referral was 24.7 weeks gestational age. Approximately 50% of the patients had no antenatal screening. Detailed analysis such as geographical mapping demonstrated regional differences in fetal anomalies prevalence, practice differences and clinical outcomes.

CONCLUSIONS:

Accurate, precise and real-time collection of fetal care and health systems utilization information establishes a new benchmark, and reveals some critical deficiencies such as lack of antenatal care and delayed referral for fetal anomalies in Ontario.

Objectives: To evaluate the effectiveness in helping pregnant women stop smoking of two interventions (Pro-Change for a healthy pregnancy) based on the transtheoretical model of behaviour change (TTM) compared to current standard care.

Design: Cluster randomised trial.

Setting: Antenatal clinics in West Midlands, UK general practices.

Participants: 918 pregnant smokers

Interventions: 100 general practices were randomised into the three trial arms. Midwives in these practices delivered three interventions: A (standard care), B (TTM based self help manuals), and C (TTM based self help manuals plus sessions with an interactive computer program giving individualised smoking cessation advice).

Main outcome measures: Biochemically confirmed smoking cessation for 10 weeks previously, and point prevalence abstinence, both measured at 30 weeks of pregnancy and 10 days after delivery.

Results: There were small differences between the TTM arms. Combining the two arms, the odds ratios at 30 weeks were 2.09 (95% confidence interval (CI) 0.90 to 4.85) for 10 week sustained abstinence and 2.92 (95% CI 1.42 to 6.03) for point prevalence abstinence relative to controls. At 10 days after delivery, the odds ratios were 2.81 (95% CI 1.11 to 7.13) and 1.85 (95% CI 1.00 to 3.41) for 10 week and point prevalence abstinence respectively.

Conclusions: While there is a small borderline significant increase in quitting in the combined intervention arms compared with the controls, the effect of the intervention is small. At 30 weeks gestation and at 10 days postnatal, only about 3% of the intervention groups achieved sustained cessation, with numbers needed to treat of 67 (30 weeks of gestation) and 53 (10 weeks postnatal) for one additional woman to achieve sustained confirmed cessation. Given also that the intervention was resource intensive, it is of doubtful benefit.

Background

Uncontrolled asthma during pregnancy is associated with the maternal hazards of disease exacerbation, and perinatal hazards including intrauterine growth restriction and preterm birth. Interventions directed at achieving better asthma control during pregnancy should be considered a high priority in order to optimise both maternal and perinatal outcomes. Poor compliance with prescribed asthma medications during pregnancy and suboptimal prescribing patterns to pregnant women have both been shown to be contributing factors that jeopardise asthma control. The aim is to design and evaluate an intervention involving multidisciplinary care for women experiencing asthma in pregnancy.

Methods/design

A pilot single-blinded parallel-group randomized controlled trial testing a Multidisciplinary Approach to Management of Maternal Asthma (MAMMA©) which involves education and regular monitoring. Pregnant women with asthma will be recruited from antenatal clinics in Victoria, Australia. Recruited participants, stratified by disease severity, will be allocated to the intervention or the usual care group in a 1:1 ratio. Both groups will be followed prospectively throughout pregnancy and outcomes will be compared between groups at three and six months after recruitment to evaluate the effectiveness of this intervention. Outcome measures include Asthma Control Questionnaire (ACQ) scores, oral corticosteroid use, asthma exacerbations and asthma related hospital admissions, and days off work, preventer to reliever ratio, along with pregnancy and neonatal adverse events at delivery. The use of FEV1/FEV6 will be also investigated during this trial as a marker for asthma control.

Discussion

If successful, this model of care could be widely implemented in clinical practice and justify more funding for support services and resources for these women. This intervention will also promote awareness of the risks of poorly controlled asthma and the need for a collaborative, multidisciplinary approach to asthma management during pregnancy. This is also the first study to investigate the use of FEV1/FEV6 as a marker for asthma control during pregnancy.

Trial registration

Australian New Zealand Clinical Trials Registry (ACTRN12612000681853)

Background

The increased prevalence of obesity in pregnant women in Australia and other developed countries is a significant public health concern. Obese women are at increased risk of serious perinatal complications and guidelines recommend weight gain restriction and additional care. There is limited evidence to support the effectiveness of dietary and physical activity lifestyle interventions in preventing adverse perinatal outcomes and new strategies need to be evaluated. The primary aim of this project is to evaluate the effect of continuity of midwifery care on restricting gestational weight gain in obese women to the recommended range. The secondary aims of the study are to assess the impact of continuity of midwifery care on: women's experience of pregnancy care; women's satisfaction with care and a range of psychological factors.

Methods/Design

A two arm randomised controlled trial (RCT) will be conducted with primigravid women recruited from maternity services in Victoria, Australia. Participants will be primigravid women, with a BMI≥30 who are less than 17 weeks gestation. Women allocated to the intervention arm will be cared for in a midwifery continuity of care model and receive an informational leaflet on managing weight gain in pregnancy. Women allocated to the control group will receive routine care in addition to the same informational leaflet. Weight gain during pregnancy, standards of care, medical and obstetric information will be extracted from medical records. Data collected at recruitment (self administered survey) and at 36 weeks by postal survey will include socio-demographic information and the use of validated scales to measure secondary outcomes.

Discussion

Continuity of midwifery care models are well aligned with current Victorian, Australian and many international government policies on maternity care. Increasingly, midwifery continuity models of care are being introduced in low risk maternity care, and information on their application in high risk populations is required. There is an identified need to trial alternative antenatal interventions to reduce perinatal risk factors for women who are obese and the findings from this project may have application in other maternity services. In addition this study will inform a larger trial that will focus on birth and postnatal outcomes.

Trial Registration

Australian New Zealand Clinical Trials Registry ACTRN12610001078044.

Background

A community-based randomized control prenatal care trial was performed in a rural county of China during 2000-2003. The purpose of this paper is to describe the trial implementation and the impact of the trial on the utilization of prenatal care and perinatal outcomes.

Materials and methods

In the study county, 10 townships (from a total of 55) were each paired with a control (20 study townships in total), with the criteria for pairing being the township's socioeconomic development, perinatal health, and maternal care utilization and provision. One of each township pair was randomly allocated to the intervention or control groups. The trial interventions were: 1) training township hospital midwives and instructing them in how to provide systematic maternal care, 2) informing women in the community of the importance of prenatal care, 3) if needed, providing basic medical instruments to the hospitals. A variety of data sources were used to describe the trial implementation (observations, group discussions, field notes, survey to women). The data on pregnancy and perinatal outcomes were from the original hand-written work-records in the village family planning centers of the study townships.

Results

Implementation of the intervention was deficient. The factors hindering the trial implementation included poor coordination between midwives and family planning officers, broader policy changes implemented by the provincial government during the trial, the decentralization of county governance, and the lack of government funding for maternal care. There was only little difference in the use of maternal care, in women's opinions related to maternal care or content of prenatal care, and no difference in the perinatal outcomes between the intervention and control townships.

Conclusions

A community based randomized controlled trial could not be fully carried out in rural China as planned due to the changing political landscape, the complexity of the socio-economic situation and a lengthy planning stage. The study could not answer if perinatal outcomes could be improved by increased use of prenatal care.

Trial registration

NCT 01054235

Background

Perinatal (mortality) audit can be considered to be a way to improve the careprocess for all pregnant women and their newborns by creating an opportunity to learn from unwanted events in the care process. In unit-based perinatal audit, the caregivers involved in cases that result in mortality are usually part of the audit group. This makes such an audit a delicate matter.

Methods

The purpose of this study was to implement unit-based perinatal mortality audit in all 15 perinatal cooperation units in the northern region of the Netherlands between September 2007 and March 2010. These units consist of hospital-based and independent community-based perinatal caregivers. The implementation strategy encompassed an information plan, an organization plan, and a training plan. The main outcomes are the number of participating perinatal cooperation units at the end of the project, the identified substandard factors (SSF), the actions to improve care, and the opinions of the participants.

Results

The perinatal mortality audit was implemented in all 15 perinatal cooperation units. 677 different caregivers analyzed 112 cases of perinatal mortality and identified 163 substandard factors. In 31% of cases the guidelines were not followed and in 23% care was not according to normal practice. In 28% of cases, the documentation was not in order, while in 13% of cases the communication between caregivers was insufficient. 442 actions to improve care were reported for ‘external cooperation’ (15%), ‘internal cooperation’ (17%), ‘practice organization’ (26%), ‘training and education’ (10%), and ‘medical performance’ (27%). Valued aspects of the audit meetings were: the multidisciplinary character (13%), the collective and non-judgmental search for substandard factors (21%), the perception of safety (13%), the motivation to reflect on one’s own professional performance (5%), and the inherent postgraduate education (10%).

Conclusion

Following our implementation strategy, the perinatal mortality audit has been successfully implemented in all 15 perinatal cooperation units. An important feature was our emphasis on the delicate character of the caregivers evaluating the care they provided. However, the actual implementation of the proposed actions for improving care is still a point of concern.

Few interventions have succeeded in reducing psychosocial risk among pregnant women. The objective of this study was to determine whether an integrated group prenatal care intervention already shown to improve perinatal and sexual risk outcomes can also improve psychosocial outcomes compared to standard individual care. This randomised controlled trial included pregnant women ages 14–25 from two public hospitals (N = 1047) who were randomly assigned to standard individual care, group prenatal care or integrated group prenatal care intervention (CenteringPregnancy Plus, CP+). Timing and content of visits followed obstetrical guidelines, from 18-week gestation through birth. Each 2-h group prenatal care session included physical assessment, education/skills building and support via facilitated discussion. Using intention-to-treat models, there were no significant differences in psychosocial function; yet, women in the top tertile of psychosocial stress at study entry did benefit from integrated group care. High-stress women randomly assigned to CP+ reported significantly increased self-esteem, decreased stress and social conflict in the third trimester of pregnancy; social conflict and depression were significantly lower 1-year postpartum (all p-values <0.02). CP+ improved psychosocial outcomes for high-stress women. This ‘bundled’ intervention has promise for improving psychosocial outcomes, especially for young pregnant women who are traditionally more vulnerable and underserved.

Background

Smoking cessation interventions in pregnancy could influence a woman's social behaviour and her partner's smoking behaviour, but this has not been examined in any published randomized trials.

Method

918 women smoking at booking for antenatal care were enrolled in a cluster-randomized trial of three interventions: standard care, self-help manual and enhanced stage-based counselling, or self-help manual, enhanced stage-based counselling and use of an interactive computer program. The outcomes were change in social support received by women between booking for maternity care and 30 weeks gestation and 10 days postpartum and reported cessation in the woman's partner at these times.

Results

Few pregnant women's partners stopped smoking (4.1% at 30 weeks of gestation and 5.8% at 10 days postpartum) and the probability of quitting did not differ significantly by trial arm. Women's scores on the Inventory of Socially Supportive Behaviors showed a slight decline from booking to 30 weeks gestation, and a slight increase to 10 days postpartum, but these changes did not differ significantly by trial arm.

Conclusion

The stage-based interventions tested in this trial aimed partly to influence women's mobilization of support and might have influenced partners' quitting, but there was no evidence that they did so. Given that women and their partners often stopped smoking together, future interventions to prevent smoking in pregnant women could encourage both partners to quit together.

Background

Antenatal care is widely established and provides an opportunity to inform and educate pregnant women about pregnancy, childbirth and care of the newborn. It is expected that this would assist the women in making choices that would contribute to good pregnancy outcome. We examined the provision of information and education in antenatal clinics from the perspective of pregnant women attending these clinics.

Methods

A cross sectional survey of 457 pregnant women attending six urban and six rural antenatal clinics in the largest health division in The Gambia was undertaken. The women were interviewed using modified antenatal client exit interview and antenatal record review questionnaires from the WHO Safe Motherhood Needs Assessment kit. Differences between women attending urban and rural clinics were assessed using the Chi-square test. Relative risks with 95% confidence intervals are presented.

Results

Ninety percent of those interviewed had attended the antenatal clinic more than once and 52% four or more times. Most pregnant women (70.5%) said they spent 3 minutes or less with the antenatal care provider. About 35% recalled they were informed or educated on diet and nutrition, 30.4% on care of the baby, 23.6% on family planning, 22.8% on place of birth and 19.3% on what to do if there was a complication.

About 25% of pregnant women said they were given information about the progress of their pregnancy after consultation and only 12.8% asked their provider any question. Awareness of danger signs was low. The proportions of women that recognised signs of danger were 28.9% for anaemia, 24.6% for hypertension, 14.8% for haemorrhage, 12.9% for fever and 5% for puerperal sepsis. Prolonged labour was not recognised as a danger sign. Women attending rural antenatal clinics were 1.6 times more likely to recognise signs of anaemia and hypertension as indicative of danger compared to women attending urban antenatal clinics.

Conclusion

Information, education and communication during antenatal care in the largest health division are poor. Pregnant women are ill-equipped to make appropriate choices especially when they are in danger. This contributes to the persistence of high maternal mortality ratios in the country.

Background

The World Health Organization recommends dry cord care for newborns but this recommendation may not be optimal in low resource settings where most births take place in an unclean environment and infections account for up to half of neonatal deaths. A previous trial in Nepal indicated that umbilical cord cleansing with 4.0% chlorhexidine could substantially reduce mortality and omphalitis risk, but policy changes await additional community-based data.

Methods

The Projahnmo Chlorhexidine study was a three-year, cluster-randomized, community-based trial to assess the impact of three cord care regimens on neonatal mortality and omphalitis. Women were recruited mid-pregnancy, received a basic package of maternal and neonatal health promotion messages, and were followed to pregnancy outcome. Newborns were visited at home by local village-based workers whose areas were randomized to either 1) single- or 2) 7-day cord cleansing with 4.0% chlorhexidine, or 3) promotion of dry cord care as recommended by WHO. All mothers received basic messages regarding hand-washing, clean cord cutting, and avoidance of harmful home-base applications to the cord. Death within 28 days and omphalitis were the primary outcomes; these were monitored directly through home visits by community health workers on days 1, 3, 6, 9, 15, and 28 after birth.

Discussion

Due to report in early 2010, the Projahnmo Chlorhexidine Study examines the impact of multiple or single chlorhexidine cleansing of the cord on neonatal mortality and omphalitis among newborns of rural Sylhet District, Bangladesh. The results of this trial will be interpreted in conjunction with a similarly designed trial previously conducted in Nepal, and will have implications for policy guidelines for optimal cord care of newborns in low resource settings in Asia.

Trial Registration

ClinicalTrials.gov (NCT00434408)

Objectives: To evaluate impact of postnatal health education for mothers on infant care and postnatal family planning practices in Nepal.

Design: Randomised controlled trial with community follow up at 3 and 6 months post partum by interview. Initial household survey of study areas to identify all pregnant women to facilitate follow up.

Setting: Main maternity hospital in Kathmandu, Nepal. Follow up in urban Kathmandu and a periurban area southwest of the city.

Subjects: 540 mothers randomly allocated to one of four groups: health education immediately after birth and three months later (group A), at birth only (group B), at three months only (group C), or none (group D).

Interventions: Structured baseline household questionnaire; 20 minute, one to one health education at birth and three months later.

Main outcome measures: Duration of exclusive breast feeding, appropriate immunisation of infant, knowledge of oral rehydration solution and need to continue breast feeding in diarrhoea, knowledge of infant signs suggesting pneumonia, uptake of postnatal family planning.

Results: Mothers in groups A and B (received health education at birth) were slightly more likely to use contraception at six months after birth compared with mothers in groups C and D (no health education at birth) (odds ratio 1.62, 95% confidence interval 1.06 to 2.5). There were no other significant differences between groups with regards to infant feeding, infant care, or immunisation.

Conclusions: Our findings suggest that the recommended practice of individual health education for postnatal mothers in poor communities has no impact on infant feeding, care, or immunisation, although uptake of family planning may be slightly enhanced.

Key messages Health education is widely promoted in primary care, but there have been few rigorous evaluations of its impact, especially in developing countries A randomised controlled trial of postnatal individual health education for mothers given by trained female health workers showed no significant impact on maternal knowledge and practices of child care or on infant health outcomes, but there was a small improvement in uptake of family planning at six months after birth The efficacy of health education interventions that rely solely on giving people information to bring about a change in health behaviour is unproved; interventions should be evaluated before being implemented on a large scale Alternative strategies for health promotion in developing countries such as interactions within families, peer groups, or communities may be more effective but are costly and difficult to implement on a large scale

Summary

Background

The treatment of perinatal depression is a public-health priority because of its high prevalence and association with disability and poor infant development. We integrated a cognitive behaviour therapy-based intervention into the routine work of community-based primary health workers in rural Pakistan and assessed the effect of this intervention on maternal depression and infant outcomes.

Methods

We randomly assigned 40 Union Council clusters in rural Rawalpindi, Pakistan, in equal numbers to intervention or control. Married women (aged 16–45 years) in their third trimester of pregnancy with perinatal depression were eligible to participate. In the intervention group, primary health workers were trained to deliver the psychological intervention, whereas in the control group untrained health workers made an equal number of visits to the depressed mothers. The primary outcomes were infant weight and height at 6 months and 12 months, and secondary outcome was maternal depression. The interviewers were unaware of what group the participants were assigned to. Analysis was by intention to treat. The study is registered as ISRCTN65316374.

Findings

The number of clusters per group was 20, with 463 mothers in the intervention group and 440 in the control group. At 6 months, 97 (23%) of 418 and 211 (53%) of 400 mothers in the intervention and control groups, respectively, met the criteria for major depression (adjusted odds ratio (OR) 0·22, 95% CI 0·14 to 0·36, p<0·0001). These effects were sustained at 12 months (111/412 [27%] vs 226/386 [59%], adjusted OR 0·23, 95% CI 0·15 to 0·36, p<0·0001). The differences in weight-for-age and height-for-age Z scores for infants in the two groups were not significant at 6 months (−0·83 vs −0·86, p=0·7 and −2·03 vs −2·16, p=0·3, respectively) or 12 months (−0·64 vs −0·8, p=0·3 and −1·10 vs −1·36, p=0·07, respectively).

Interpretation

This psychological intervention delivered by community-based primary health workers has the potential to be integrated into health systems in resource-poor settings.

Funding

Wellcome Trust.

Inability to reduce neonatal and maternal mortality in poor countries is sometimes blamed on a lack of contextual knowledge about care practices and care-seeking behavior. There is a lack of knowledge about how to translate formative research into effective interventions to improve maternal and newborn health. We describe the findings of formative research and how they were used to inform the development of such an intervention in rural Nepal. Formative research was carried out in four parts. Part 1 involved familiarization with the study area and literature review, and parts 2, 3 and 4 involved community mapping, audit of health services, and qualitative and quantitative studies of perinatal care behaviors. Participatory approaches have been successful at reducing neonatal mortality and may be suitable in our context. Community mapping and profiling helped to describe the community context, and we found that community-based organizations often sought to involve the Female Community Health Volunteer in community mobilization. She was not routinely conducting monthly meetings and found them difficult to sustain without support and supervision. In health facilities, most primary care staff were in post, but doctors and staff nurses were absent from referral centers. Mortality estimates reflected under-reporting of deaths and hygiene and infection control strategies had low coverage. The majority of women give birth at home with their mother-in-law, friends and neighbors. Care during perinatal illness was usually sought from traditional healers. Cultural issues of shyness, fear and normalcy restricted women’s behavior during pregnancy, birth and the postpartum period, and decisions about her health were usually made after communications with the family and community. The formative research indicated the type of intervention that could be successful. It should be community-based and should not be exclusively for pregnant women. It should address negotiations within families, and should tailor information to the needs of local groups and particular stakeholders such as mothers-in-law and traditional healers. The intervention should not only accept cultural constructs but also be a forum in which to discuss ideas of pollution, shame and seclusion. We used these guidelines to develop a participatory, community-based women’s group intervention, facilitated through a community action cycle. The success of our intervention may be because of its acceptability at the community level and its sensitivity to the needs and beliefs of families and communities.