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1.  A randomized controlled trial to assess the clinical and cost effectiveness of a nurse-led Antenatal Asthma Management Service in South Australia (AAMS study) 
Background
Pregnancy presents a unique situation for the management of asthma as it can alter the course of asthma severity and its treatment, which in turn can affect pregnancy outcomes. Despite awareness of the substantial adverse effects associated with asthma during pregnancy, little has been done to improve its management and reduce associated perinatal morbidity and mortality. The aim of this randomized controlled trial is to evaluate the clinical and cost effectiveness of an Antenatal Asthma Management Service.
Methods/design
Design: Multicentre, randomized controlled trial.
Inclusion criteria: Women with physician diagnosed asthma, which is not currently in remission, who are less than 20 weeks gestation with a singleton pregnancy and do not have a chronic medical condition.
Trial entry and randomization: Eligible women with asthma, stratified by treatment site, disease severity and parity, will be randomized into either the ‘Standard Care Group’ or the ‘Intervention Group’.
Study groups: Both groups will be followed prospectively throughout pregnancy. Women in the ‘Standard Care Group’ will receive routine obstetric care reflecting current clinical practice in Australian hospitals. Women in the ‘Intervention Group’ will receive additional care through the nurse-led Antenatal Asthma Management Service, based in the antenatal outpatient clinic. Women will receive asthma education with a full assessment of their asthma at 18, 24, 30 and 36 weeks gestation. Each antenatal visit will include a 60 min session where asthma management skills are assessed including: medication adherence and knowledge, inhaler device technique, recognition of asthma deterioration and possession of a written asthma action plan. Furthermore, subjects will receive education about asthma control and management skills including trigger avoidance and smoking cessation counseling when appropriate.
Primary study outcome: Asthma exacerbations during pregnancy.
Sample size: A sample size of 378 women will be sufficient to show an absolute reduction in asthma exacerbations during pregnancy of 20% (alpha 0.05 two-tailed, 90% power, 5% loss to follow-up).
Discussion
The integration of an asthma education program within the antenatal clinic setting has the significant potential to improve the participation of pregnant women in the self-management of their asthma, reduce asthma exacerbations and improve perinatal health outcomes.
Trial registration
ACTRN12613000244707
doi:10.1186/1471-2393-14-9
PMCID: PMC3893363  PMID: 24401041
Asthma; Pregnancy; Inhaled corticosteroids; Randomized controlled trial; Antenatal care; Intervention
2.  Working to improve survival and health for babies born very preterm: the WISH project protocol 
Background
Babies born very preterm (before 30 weeks gestation) are at high risk of dying in their first weeks of life, and those who survive are at risk of developing cerebral palsy in childhood. Recent high-quality evidence has shown that giving women magnesium sulphate immediately prior to very early birth can significantly increase the chances of their babies surviving free of cerebral palsy. In 2010 Australian and New Zealand clinical practice guidelines recommended this therapy. The WISH (Working to Improve Survival and Health for babies born very preterm) Project aims to bi-nationally improve and monitor the use of this therapy to reduce the risk of very preterm babies dying or having cerebral palsy.
Methods/Design
The WISH Project is a prospective cohort study. The 25 Australian and New Zealand tertiary level maternity hospitals will be provided with a package of active implementation strategies to guide the introduction and local adaptation of guideline recommendations. Surveys will be conducted at individual hospitals to evaluate outcomes related to local implementation progress and the use and value of the WISH implementation strategies. For the hospitals participating in the ‘WISH audit of uptake and health outcomes data collection’, the primary health outcomes (assessed through case note review, and 24 month corrected age questionnaires) will be: the proportion of eligible women receiving antenatal magnesium sulphate; and rates of death prior to primary hospital discharge and cerebral palsy at two years corrected age in infants born to eligible mothers. For hospitals wishing to assess factors influencing translation locally, barriers and facilitators will be measured through interviews with health care professionals, to further guide implementation strategies. Study outcomes for the early phase of the project (Year 1) will be compared with the later intervention phase (Years 2 and 3).
Discussion
The WISH Project will offer insight into the effectiveness of a multifaceted implementation strategy to improve the uptake of a novel neuroprotective therapy in obstetric clinical practice. The successful implementation of antenatal magnesium sulphate for fetal neuroprotection in Australia and New Zealand could lead to over 90 fewer very preterm babies dying or suffering the long-term consequences of cerebral palsy each year.
doi:10.1186/1471-2393-13-239
PMCID: PMC3879421  PMID: 24354790
Evidence-based practice; Implementation; Magnesium sulphate; Neuroprotection; Cerebral palsy; Preterm birth
3.  Is Consumer Response to Plain/Standardised Tobacco Packaging Consistent with Framework Convention on Tobacco Control Guidelines? A Systematic Review of Quantitative Studies 
PLoS ONE  2013;8(10):e75919.
Background and Objectives
Standardised or ‘plain’ tobacco packaging was introduced in Australia in December 2012 and is currently being considered in other countries. The primary objective of this systematic review was to locate, assess and synthesise published and grey literature relating to the potential impacts of standardised tobacco packaging as proposed by the guidelines for the international Framework Convention on Tobacco Control: reduced appeal, increased salience and effectiveness of health warnings, and more accurate perceptions of product strength and harm.
Methods
Electronic databases were searched and researchers in the field were contacted to identify studies. Eligible studies were published or unpublished primary research of any design, issued since 1980 and concerning tobacco packaging. Twenty-five quantitative studies reported relevant outcomes and met the inclusion criteria. A narrative synthesis was conducted.
Results
Studies that explored the impact of package design on appeal consistently found that standardised packaging reduced the appeal of cigarettes and smoking, and was associated with perceived lower quality, poorer taste and less desirable smoker identities. Although findings were mixed, standardised packs tended to increase the salience and effectiveness of health warnings in terms of recall, attention, believability and seriousness, with effects being mediated by the warning size, type and position on pack. Pack colour was found to influence perceptions of product harm and strength, with darker coloured standardised packs generally perceived as containing stronger tasting and more harmful cigarettes than fully branded packs; lighter coloured standardised packs suggested weaker and less harmful cigarettes. Findings were largely consistent, irrespective of location and sample.
Conclusions
The evidence strongly suggests that standardised packaging will reduce the appeal of packaging and of smoking in general; that it will go some way to reduce consumer misperceptions regarding product harm based upon package design; and will help make the legally required on-pack health warnings more salient.
doi:10.1371/journal.pone.0075919
PMCID: PMC3797796  PMID: 24146791
4.  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
5.  Community Health Workers and Health Care Delivery: Evaluation of a Women's Reproductive Health Care Project in a Developing Country 
PLoS ONE  2013;8(9):e75476.
Background
As part of the mid-term evaluation of a Women's Health Care Project, a study was conducted to compare the utilization of maternal and neonatal health (MNH) services in two areas with different levels of service in Punjab, Pakistan.
Methods
A cross-sectional survey was conducted to interview Married Women of Reproductive Age (MWRA). Information was collected on MWRA knowledge regarding danger signs during pregnancy, delivery, postnatal periods, and MNH care seeking behavior. After comparing MNH service utilization, the two areas were compared using a logistic regression model, to identify the association of different factors with the intervention after controlling for socio-demographic, economic factors and distance of the MWRA residence to a health care facility.
Results
The demographic characteristics of women in the two areas were similar, although socioeconomic status as indicated by level of education and better household amenities, was higher in the intervention area. Consequently, on univariate analysis, utilization of MNH services: antenatal care, TT vaccination, institutional delivery and use of modern contraceptives were higher in the intervention than control area. Nonetheless, multivariable analysis controlling for confounders such as socioeconomic status revealed that utilization of antenatal care services at health centers and TT vaccination during pregnancy are significantly associated with the intervention.
Conclusions
Our findings suggest positive changes in health care seeking behavior of women and families with respect to MNH. Some aspects of care still require attention, such as knowledge about danger signs and neonatal care, especially umbilical cord care. Despite overall success achieved so far in response to the Millennium Development Goals, over the past two decades decreases in maternal mortality are far from the 2015 target. This report identifies some of the key factors to improving MNH and serves as an interim measure of a national and global challenge that remains a work in progress.
doi:10.1371/journal.pone.0075476
PMCID: PMC3783381  PMID: 24086541
6.  Targeted Interventions for Improved Equity in Maternal and Child Health in Low- and Middle-Income Settings: A Systematic Review and Meta-Analysis 
PLoS ONE  2013;8(6):e66453.
Background
Targeted interventions to improve maternal and child health is suggested as a feasible and sometimes even necessary strategy to reduce inequity. The objective of this systematic review was to gather the evidence of the effectiveness of targeted interventions to improve equity in MDG 4 and 5 outcomes.
Methods and Findings
We identified primary studies in all languages by searching nine health and social databases, including grey literature and dissertations. Studies evaluating the effect of an intervention tailored to address a structural determinant of inequity in maternal and child health were included. Thus general interventions targeting disadvantaged populations were excluded. Outcome measures were limited to indicators proposed for Millennium Development Goals 4 and 5. We identified 18 articles, whereof 15 evaluated various incentive programs, two evaluated a targeted policy intervention, and only one study evaluated an intervention addressing a cultural custom. Meta-analyses of the effectiveness of incentives programs showed a pooled effect size of RR 1.66 (95% CI 1.43–1.93) for antenatal care attendance (four studies with 2,476 participants) and RR 2.37 (95% CI 1.38–4.07) for health facility delivery (five studies with 25,625 participants). Meta-analyses were not performed for any of the other outcomes due to scarcity of studies.
Conclusions
The targeted interventions aiming to improve maternal and child health are mainly limited to addressing economic disparities through various incentive schemes like conditional cash transfers and voucher schemes. This is a feasible strategy to reduce inequity based on income. More innovative action-oriented research is needed to speed up progress in maternal and child survival among the most disadvantaged populations through interventions targeting the underlying structural determinants of inequity.
doi:10.1371/journal.pone.0066453
PMCID: PMC3688766  PMID: 23840474
7.  Australasian randomised trial to evaluate the role of maternal intramuscular dexamethasone versus betamethasone prior to preterm birth to increase survival free of childhood neurosensory disability (A*STEROID): study protocol 
Background
Both dexamethasone and betamethasone, given to women at risk of preterm birth, substantially improve short-term neonatal health, increase the chance of the baby being discharged home alive, and reduce childhood neurosensory disability, remaining safe into adulthood. However, it is unclear which corticosteroid is of greater benefit to mother and child.
This study aims to determine whether giving dexamethasone to women at risk of preterm birth at less than 34 weeks’ gestation increases the chance of their children surviving free of neurosensory disability at two years’ corrected age, compared with betamethasone.
Methods/Design
Design randomised, multicentre, placebo controlled trial.
Inclusion criteria women at risk of preterm birth at less than 34 weeks’ gestation with a singleton or twin pregnancy and no contraindications to the use of antenatal corticosteroids and who give informed consent.
Trial entry & randomisation at telephone randomisation eligible women will be randomly allocated to either the dexamethasone group or the betamethasone group, allocated a study number and corresponding treatment pack.
Study groups women in the dexamethasone group will be administered two syringes of 12 mg dexamethasone (dexamethasone sodium phosphate) and women in the betamethasone group will be administered two syringes of 11.4 mg betamethasone (Celestone Chronodose). Both study groups consist of intramuscular treatments 24 hours apart.
Primary study outcome death or any neurosensory disability measured in children at two years’ corrected age.
Sample size a sample size of 1449 children is required to detect either a decrease in death or any neurosensory disability from 27.0% to 20.1% with dexamethasone compared with betamethasone, or an increase from 27.0% to 34.5% (two-sided alpha 0.05, 80% power, 5% loss to follow up, design effect 1.2).
Discussion
This study will provide high-level evidence of direct relevance for clinical practice. If one drug clearly results in significantly fewer deaths and fewer disabled children then it should be used consistently in women at risk of preterm birth and would be of great importance to women at risk of preterm birth, their children, health services and communities.
Trial registration
Trial registration number: ACTRN12608000631303
doi:10.1186/1471-2393-13-104
PMCID: PMC3655914  PMID: 23642125
Antenatal corticosteroids; Dexamethasone; Betamethasone; Preterm birth; Randomised controlled trial; Neurosensory disability
8.  Preeclampsia as a Risk Factor for Diabetes: A Population-Based Cohort Study 
PLoS Medicine  2013;10(4):e1001425.
Denice Feig and colleagues assess the association between gestational diabetes, gestational hypertension, and preeclampsia and the development of future diabetes in a database analysis of pregnant women in Ontario, Canada.
Background
Women with preeclampsia (PEC) and gestational hypertension (GH) exhibit insulin resistance during pregnancy, independent of obesity and glucose intolerance. Our aim was to determine whether women with PEC or GH during pregnancy have an increased risk of developing diabetes after pregnancy, and whether the presence of PEC/GH in addition to gestational diabetes (GDM) increases the risk of future (postpartum) diabetes.
Methods and Findings
We performed a population-based, retrospective cohort study for 1,010,068 pregnant women who delivered in Ontario, Canada between April 1994 and March 2008. Women were categorized as having PEC alone (n = 22,933), GH alone (n = 27,605), GDM alone (n = 30,852), GDM+PEC (n = 1,476), GDM+GH (n = 2,100), or none of these conditions (n = 925,102). Our main outcome was a new diagnosis of diabetes postpartum in the following years, up until March 2011, based on new records in the Ontario Diabetes Database. The incidence rate of diabetes per 1,000 person-years was 6.47 for women with PEC and 5.26 for GH compared with 2.81 in women with neither of these conditions. In the multivariable analysis, both PEC alone (hazard ratio [HR] = 2.08; 95% CI 1.97–2.19) and GH alone (HR = 1.95; 95% CI 1.83–2.07) were risk factors for subsequent diabetes. Women with GDM alone were at elevated risk of developing diabetes postpartum (HR = 12.77; 95% CI 12.44–13.10); however, the co–presence of PEC or GH in addition to GDM further elevated this risk (HR = 15.75; 95% CI 14.52–17.07, and HR = 18.49; 95% CI 17.12–19.96, respectively). Data on obesity were not available.
Conclusions
Women with PEC/GH have a 2-fold increased risk of developing diabetes when followed up to 16.5 years after pregnancy, even in the absence of GDM. The presence of PEC/GH in the setting of GDM also raised the risk of diabetes significantly beyond that seen with GDM alone. A history of PEC/GH during pregnancy should alert clinicians to the need for preventative counseling and more vigilant screening for diabetes.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Diabetes is a chronic disease that occurs either when the pancreas does not produce enough insulin (a hormone that regulates blood sugar), known as type 1 diabetes, or when the body cannot effectively use the insulin it produces—type 2 diabetes. Raised blood sugar, is a common effect of uncontrolled diabetes and over time leads to serious complications and even death. Worryingly, the global burden of type 2 diabetes is increasing worldwide, and the World Health Organization estimates that 90% of the 347 million people with diabetes currently have type 2 diabetes. Previous studies have shown that type 2 diabetes can be prevented or delayed in high risk groups by a range of lifestyle and treatment interventions and so it is important to identify potential high risk groups to screen for type 2 diabetes.
Why Was This Study Done?
Gestational diabetes (a form of diabetes that is related to pregnancy) is a major risk factor for developing type 2 diabetes. Therefore, diabetes prevention strategies should target women with gestational diabetes. Likewise, other common disorders of pregnancy possibly associated with insulin resistance, such as preeclampsia (a condition in which affected women have high blood pressure, fluid retention, and protein in their urine) and gestational hypertension (high blood pressure associated with pregnancy), may lead to the future development of type 2 diabetes. So women with these conditions may also benefit from diabetes prevention strategies. Therefore, in this large database study from Ontario, Canada, the researchers examined whether pregnant women with preeclampsia or gestational hypertension had an increased risk of developing diabetes in the years following pregnancy even if they did not have gestational diabetes.
What Did the Researchers Do and Find?
The researchers used a comprehensive Canadian health database to identify all women age 15 to 50 years of age who delivered in an Ontario hospital between April 1994 and March 2008. They then identified women who had preeclampsia, gestational hypertension, or gestational diabetes through hospital records and outpatient information. The researchers then used records from the Ontario Diabetes Database to record whether these women went on to develop diabetes in the period from 180 days after delivery until March 2011.
Using these methods, the researchers identified 1,010,068 pregnant women suitable for analysis, of whom 22,933 had only preeclampsia, 27,605 had only gestational hypertension, and 30,852 had only gestational diabetes: 2,100 women had both gestational diabetes and gestational hypertension and 1,476 women had gestational diabetes and preeclampsia. Overall, 35,077 women developed diabetes (3.5%) in the follow-up period (median of 8.5 years) at a median age of 37 years. In a modeling analysis, the researchers found that women with gestational diabetes had a 15-fold increased rate of developing diabetes compared to women without gestational diabetes, gestational hypertension, and preeclampsia, while women with gestational diabetes plus either preeclampsia or gestational hypertension had a 20- to 21-fold increased rate. These results were slightly reduced after adjusting for age, income quintile, hypertension prior to pregnancy, and co-morbidity, giving a hazard ratio (HR) of 1.95 for gestational hypertension alone, an HR of 2.08 for preeclampsia alone, an HR of 12.77 for gestational diabetes alone, an HR of 18.49 for gestational diabetes plus gestational hypertension and finally, an HR of 15.75 for gestational diabetes plus preeclampsia.
These Findings Mean?
These findings suggest that both preeclampsia and gestational hypertension without gestational diabetes are associated with a 2-fold increased incidence of diabetes in the years following pregnancy after controlling for several important variables. When combined with gestational diabetes, these conditions were associated with a further elevation in diabetes incidence additional to the 13-fold increased incidence resulting from gestational diabetes alone. A limitation of this study was the lack of information on obesity and body mass index, factors which are also associated with increased risk of developing diabetes. Nevertheless, these findings highlight a possible new risk factor for diabetes, and suggest that clinicians should be aware of the need for preventative measures and vigilant screening for diabetes in women with a history of preeclampsia or gestational hypertension.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001425.
NHS Choices has information about preeclampsia, gestational diabetes, and gestational hypertension
Living with diabetes is a useful resource for patients with diabetes
The Preeclampsia Foundation has more information about preeclampsia
doi:10.1371/journal.pmed.1001425
PMCID: PMC3627640  PMID: 23610560
9.  The DIAMIND study: postpartum SMS reminders to women who have had gestational diabetes mellitus to test for type 2 diabetes: a randomised controlled trial – study protocol 
Background
Postpartum follow up of women who have been found to have gestational diabetes during pregnancy is essential because of the strong association of gestational diabetes with subsequent type 2 diabetes. Postal reminders have been shown to increase significantly attendance for oral glucose tolerance testing postpartum. It is possible that a short message service (text) reminder system may also be effective. This trial aims to assess whether a text message reminder system for women who have experienced gestational diabetes in their index pregnancy will increase attendance for oral glucose tolerance testing within six months after birth.
Methods/Design
Design: Single centre (Women’s and Children’s Hospital, South Australia), parallel group randomised controlled trial.
Inclusion criteria: Women diagnosed with gestational diabetes in their index pregnancy (oral glucose tolerance test with fasting glucose ≥ 5.5 mmol/L and/or two hour glucose ≥ 7.8 mmol/L), with access to a mobile phone, whose capillary blood glucose profile measurements prior to postnatal discharge are all normal (fasting glucose < 6.0 mmol/L, postprandial glucoses < 8.0 mmol/L).
Exclusion criteria: Pregestational diabetes mellitus, triplet/higher order multiple birth or stillbirth in the index pregnancy, requirement for interpreter.
Trial entry and randomisation: Allocation to intervention will be undertaken using a telephone randomisation service (computer-generated random number sequence generation, with balanced variable blocks, and stratification by insulin requirement).
Study groups: Women in the intervention group will receive a text reminder to attend for an oral glucose tolerance test at 6 weeks postpartum, with further reminders at 3 months and 6 months if they do not respond to indicate test completion. Women in the control group will receive a single text message reminder at 6 months postpartum.
Blinding: Baseline data collection will be undertaken blinded. Blinding of participants and blinded collection of primary outcome data will not be possible for this study.
Primary study outcome: Attendance for the oral glucose tolerance test within 6 months postpartum.
Sample size: 276 subjects will be required to show an 18% absolute increase in the rate of attendance (α=0.05 two tailed, β=80%, 5% loss to follow up) from 37% to 55% in the intervention group.
Discussion
Given the heightened risk of impaired glucose tolerance and type 2 diabetes in women who have had gestational diabetes, ensuring the highest possible rate of attendance for postpartum glucose tolerance testing, so that early diagnosis and intervention can occur, is important. A text message reminder system may prove to be an effective method for achieving improved attendance for such testing. This randomised controlled trial will assess whether such a system will increase rates of attendance for postpartum oral glucose tolerance testing in women who have experienced gestational diabetes.
Trial Registration
Australian New Zealand Clinical Trials Registry - ACTRN12612000621819
doi:10.1186/1471-2393-13-92
PMCID: PMC3626874  PMID: 23587090
Gestational diabetes mellitus; Reminder system; SMS text reminder; Randomised controlled trial; Postpartum care; Oral glucose tolerance test; Type 2 diabetes mellitus
10.  Magnesium sulphate at 30 to 34 weeks’ gestational age: neuroprotection trial (MAGENTA) - study protocol 
Background
Magnesium sulphate is currently recommended for neuroprotection of preterm infants for women at risk of preterm birth at less than 30 weeks’ gestation, based on high quality evidence of benefit. However there remains uncertainty as to whether these benefits apply at higher gestational ages.
The aim of this randomised controlled trial is to assess whether giving magnesium sulphate compared with placebo to women immediately prior to preterm birth between 30 and 34 weeks’ gestation reduces the risk of death or cerebral palsy in their children at two years’ corrected age.
Methods/design
Design: Randomised, multicentre, placebo controlled trial.
Inclusion criteria: Women, giving informed consent, at risk of preterm birth between 30 to 34 weeks’ gestation, where birth is planned or definitely expected within 24 hours, with a singleton or twin pregnancy and no contraindications to the use of magnesium sulphate.
Trial entry & randomisation: Eligible women will be randomly allocated to receive either magnesium sulphate or placebo.
Treatment groups: Women in the magnesium sulphate group will be administered 50 ml of a 100 ml infusion bag containing 8 g magnesium sulphate heptahydrate [16 mmol magnesium ions]. Women in the placebo group will be administered 50 ml of a 100 ml infusion bag containing isotonic sodium chloride solution (0.9%). Both treatments will be administered through a dedicated IV infusion line over 30 minutes.
Primary study outcome: Death or cerebral palsy measured in children at two years’ corrected age.
Sample size: 1676 children are required to detect a decrease in the combined outcome of death or cerebral palsy, from 9.6% with placebo to 5.4% with magnesium sulphate (two-sided alpha 0.05, 80% power, 5% loss to follow up, design effect 1.2).
Discussion
Given the magnitude of the protective effect in the systematic review, the ongoing uncertainty about benefits at later gestational ages, the serious health and cost consequences of cerebral palsy for the child, family and society, a trial of magnesium sulphate for women at risk of preterm birth between 30 to 34 weeks’ gestation is both important and relevant for clinical practice globally.
Trial registration
Australian New Zealand Clinical Trials Registry - ACTRN12611000491965
doi:10.1186/1471-2393-13-91
PMCID: PMC3636106  PMID: 23570677
Magnesium sulphate; Neuroprotection; Preterm birth; Randomised controlled trial; Cerebral palsy
11.  Asthma Management in Pregnancy 
PLoS ONE  2013;8(4):e60247.
Background
Asthma is common during pregnancy, however research is limited regarding the extent and timing of changes in asthma management associated with pregnancy.
Objective
To determine the prevalence of asthma during pregnancy and identify changes in treatment and asthma exacerbation rates associated with pregnancy, while controlling for seasonal influences.
Methods
Pregnant women with asthma were identified from the UK General Practice Research Database between 2000 and 2008. For each woman asthma medication prescribed during the study period was identified; for each product combination the British Thoracic Society medication-defined asthma treatment step was identified. Asthma exacerbations were identified during pregnancy and in the corresponding 12 months prior. Analyses of changes in asthma treatment and exacerbation rates during pregnancy relative to the corresponding period 12 months prior, to control for seasonality, were stratified by trimester and asthma treatment intensity level.
Results
The prevalence of treated asthma in pregnancies resulting in a delivery was 8.3%. From 14,141 pregnancies, in 12,828 women with asthma, 68.4% received prescriptions for a short-acting β2-agonist and 41.2% for inhaled corticosteroids; 76.5% were managed with asthma treatment Step 1 or 2. Poor persistence to inhaled corticosteroids, defined as a gap of up to 60 days between prescriptions, was common. In 45.0% of pregnancies, an increase in average treatment step was observed whereas in 25.6% the treatment step decreased. Treatment intensity remained the same in 29.5% of pregnancies. Exacerbations occurred in 4.8% of pregnancies compared to 5.9% in the same season the year before (p<0.001).
Conclusion
Exacerbation rates during pregnancy were slightly lower than in the year before. However, treatment patterns and exacerbation rates in this study suggest asthma control during pregnancy is variable, and women may require close monitoring especially in those with evidence of poor control before pregnancy.
doi:10.1371/journal.pone.0060247
PMCID: PMC3617219  PMID: 23593182
12.  Outcomes of Induction of Labour in Women with Previous Caesarean Delivery: A Retrospective Cohort Study Using a Population Database 
PLoS ONE  2013;8(4):e60404.
Background
There is evidence that induction of labour (IOL) around term reduces perinatal mortality and caesarean delivery rates when compared to expectant management of pregnancy (allowing the pregnancy to continue to await spontaneous labour or definitive indication for delivery). However, it is not clear whether IOL in women with a previous caesarean section confers the same benefits. The aim of this study was to describe outcomes of IOL at 39–41 weeks in women with one previous caesarean delivery and to compare outcomes of IOL or planned caesarean delivery to those of expectant management.
Methods and Findings
We performed a population-based retrospective cohort study of singleton births greater than 39 weeks gestation, in women with one previous caesarean delivery, in Scotland, UK 1981–2007 (n = 46,176). Outcomes included mode of delivery, perinatal mortality, neonatal unit admission, postpartum hemorrhage and uterine rupture. 40.1% (2,969/7,401) of women who underwent IOL 39–41 weeks were ultimately delivered by caesarean. When compared to expectant management IOL was associated with lower odds of caesarean delivery (adjusted odds ratio [AOR] after IOL at 39 weeks of 0.81 [95% CI 0.71–0.91]). There was no significant effect on the odds of perinatal mortality but greater odds of neonatal unit admission (AOR after IOL at 39 weeks of 1.29 [95% CI 1.08–1.55]). In contrast, when compared with expectant management, elective repeat caesarean delivery was associated with lower perinatal mortality (AOR after planned caesarean at 39 weeks of 0.23 [95% CI 0.07–0.75]) and, depending on gestation, the same or lower neonatal unit admission (AOR after planned caesarean at 39 weeks of 0.98 [0.90–1.07] at 40 weeks of 1.08 [0.94–1.23] and at 41 weeks of 0.77 [0.60–1.00]).
Conclusions
A more liberal policy of IOL in women with previous caesarean delivery may reduce repeat caesarean delivery, but increases the risks of neonatal complications.
doi:10.1371/journal.pone.0060404
PMCID: PMC3615029  PMID: 23565242
13.  Health System Barriers to Access and Use of Magnesium Sulfate for Women with Severe Pre-Eclampsia and Eclampsia in Pakistan: Evidence for Policy and Practice 
PLoS ONE  2013;8(3):e59158.
Severe pre-eclampsia and eclampsia are rare but serious complications of pregnancy that threaten the lives of mothers during childbirth. Evidence supports the use of magnesium sulfate (MgSO4) as the first line treatment option for severe pre-eclampsia and eclampsia. Eclampsia is the third major cause of maternal mortality in Pakistan. As in many other Low- and Middle-Income Countries (LMIC), it is suspected that MgSO4 is critically under-utilized in the country. There is however a lack of information on context-specific health system barriers that prevent optimal use of this life-saving medicine in Pakistan. Combining quantitative and qualitative methods, namely policy document review, key informant interviews, focus group discussions and direct observation at health facility, we explored context-specific health system barriers and enablers that affect access and use of MgSO4 for severe pre-eclampsia and eclampsia in Pakistan. Our study finds that while international recommendations on MgSO4 have been adequately translated in national policies in Pakistan, the gap remains in implementation of national policies into practice. Barriers to access to and effective use of MgSO4 occur at health facility level where the medicine was not available and health staff was reluctant to use it. Low price of the medicine and the small market related to its narrow indications acted as disincentives for effective marketing. Results of our survey were further discussed in a multi-stakeholder round-table meeting and an action plan for increasing access to this life-saving medicine was identified.
doi:10.1371/journal.pone.0059158
PMCID: PMC3608621  PMID: 23555626
14.  The Impact of Official Development Aid on Maternal and Reproductive Health Outcomes: A Systematic Review 
PLoS ONE  2013;8(2):e56271.
Background
Progress toward meeting Millennium Development Goal 5, which aims to improve maternal and reproductive health outcomes, is behind schedule. This is despite ever increasing volumes of official development aid targeting the goal, calling into question the distribution and efficacy of aid. The 2005 Paris Declaration on Aid Effectiveness represented a global commitment to reform aid practices in order to improve development outcomes, encouraging a shift toward collaborative aid arrangements which support the national plans of aid recipient countries (and discouraging unaligned donor projects).
Methods and Findings
We conducted a systematic review to summarise the evidence of the impact on MDG 5 outcomes of official development aid delivered in line with Paris aid effectiveness principles and to compare this with the impact of aid in general on MDG 5 outcomes. Searches of electronic databases identified 30 studies reporting aid-funded interventions designed to improve maternal and reproductive health outcomes. Aid interventions appear to be associated with small improvements in the MDG indicators, although it is not clear whether changes are happening because of the manner in which aid is delivered. The data do not allow for a meaningful comparison between Paris style and general aid. The review identified discernible gaps in the evidence base on aid interventions targeting MDG 5, notably on indicators MDG 5.4 (adolescent birth rate) and 5.6 (unmet need for family planning).
Discussion
This review presents the first systematic review of the impact of official development aid delivered according to the Paris principles and aid delivered outside this framework on MDG 5 outcomes. Its findings point to major gaps in the evidence base and should be used to inform new approaches and methodologies aimed at measuring the impact of official development aid.
doi:10.1371/journal.pone.0056271
PMCID: PMC3579872  PMID: 23468860
15.  Caesarean Delivery and Subsequent Stillbirth or Miscarriage: Systematic Review and Meta-Analysis 
PLoS ONE  2013;8(1):e54588.
Objective
To compare the risk of stillbirth and miscarriage in a subsequent pregnancy in women with a previous Caesarean or vaginal delivery.
Design
Systematic review of the published literature including seven databases: CINAHL; the Cochrane library; Embase; Medline; PubMed; SCOPUS and Web of Knowledge from 1945 until November 11th 2011, using a detailed search-strategy and cross-checking of reference lists.
Study Selection
Cohort, case-control and cross-sectional studies examining the association between previous Caesarean section and subsequent stillbirth or miscarriage risk. Two assessors screened titles to identify eligible studies, using a standardised data abstraction form and assessed study quality.
Data synthesis
11 articles were included for stillbirth, totalling 1,961,829 pregnancies and 7,308 events. Eight eligible articles were included for miscarriage, totalling 147,017 pregnancies and 12,682 events. Pooled estimates across the stillbirth studies were obtained using random-effect models. Among women with a previous Caesarean an increase in odds of 1.23 [95% CI 1.08, 1.40] for stillbirth was yielded. Subgroup analyses including unexplained stillbirths yielded an OR of 1.47 [95% CI 1.20, 1.80], an OR of 2.11 [95% CI 1.16, 3.84] for explained stillbirths and an OR of 1.27 [95% CI 0.95, 1.70] for antepartum stillbirths. Only one study reported adjusted estimates in the miscarriage review, therefore results are presented individually.
Conclusions
Given the recent revision of the National Institute for Health and Clinical Excellence guidelines (NICE), providing women the right to request a Caesarean, it is essential to establish whether mode of delivery has an association with subsequent risk of stillbirth or miscarriage. Overall, compared to vaginal delivery, the pooled estimates suggest that Caesarean delivery may increase the risk of stillbirth by 23%. Results for the miscarriage review were inconsistent and lack of adjustment for confounding was a major limitation. Higher methodological quality research is required to reliably assess the risk of miscarriage in subsequent pregnancies.
doi:10.1371/journal.pone.0054588
PMCID: PMC3553078  PMID: 23372739
16.  Physician Care Patterns and Adherence to Postpartum Glucose Testing after Gestational Diabetes Mellitus in Oregon 
PLoS ONE  2012;7(10):e47052.
Objective
This study examines obstetrician/gynecologists and family medicine physicians' reported care patterns, attitudes and beliefs and predictors of adherence to postpartum testing in women with a history of gestational diabetes mellitus.
Research Design and Methods
In November–December 2005, a mailed survey went to a random, cross-sectional sample of 683 Oregon licensed physicians in obstetrician/gynecologists and family medicine from a population of 2171.
Results
Routine postpartum glucose tolerance testing by both family physicians (19.3%) and obstetrician/gynecologists physicians (35.3%) was reportedly low among the 285 respondents (42% response rate). Factors associated with high adherence to postpartum testing included physician stated priority (OR 4.39, 95% CI: 1.69–7.94) and physician beliefs about norms or typical testing practices (OR 3.66, 95% CI: 1.65–11.69). Specialty, sex of physician, years of practice, location, type of practice, other attitudes and beliefs were not associated with postpartum glucose tolerance testing.
Conclusions
Postpartum glucose tolerance testing following a gestational diabetes mellitus pregnancy was not routinely practiced by responders to this survey. Our findings indicate that physician knowledge, attitudes and beliefs may in part explain suboptimal postpartum testing. Although guidelines for postpartum care are established, some physicians do not prioritize these guidelines in practice and do not believe postpartum testing is the norm among their peers.
doi:10.1371/journal.pone.0047052
PMCID: PMC3469538  PMID: 23071709
17.  The IDEAL study: investigation of dietary advice and lifestyle for women with borderline gestational diabetes: a randomised controlled trial - study protocol 
Background
The Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) showed that treatment of pregnant women with mild gestational diabetes mellitus is beneficial for both women and their infants. It is still uncertain whether there are benefits of similar treatment for women with borderline gestational diabetes.
This trial aims to assess whether dietary and lifestyle advice and treatment given to pregnant women who screen for borderline gestational diabetes reduces neonatal complications and maternal morbidities.
Methods/design
Design: Multicentre, randomised controlled trial.
Inclusion criteria: Women between 240 and 346 weeks gestation with a singleton pregnancy, a positive oral glucose challenge test (venous plasma glucose ≥7.8 mmol/L) and a normal oral 75 gram glucose tolerance test (fasting venous plasma glucose <5.5 mmol/L and a 2 hour glucose <7.8 mmol/L) with written, informed consent.
Trial entry and randomisation: Women with an abnormal oral glucose tolerance test (fasting venous plasma glucose ≥5.5 mmol/L or 2 hour glucose ≥7.8 mmol/L) will not be eligible and will be offered treatment for gestational diabetes, consistent with recommendations based on results of the ACHOIS trial. Eligible women will be randomised into either the ‘Routine Care Group’ or the ‘Intervention Group’.
Study groups: Women in the ‘Routine Care Group’ will receive routine obstetric care reflecting current clinical practice in Australian hospitals. Women in the ‘Intervention Group’ will receive obstetric care, which will include dietary and lifestyle advice, monitoring of blood glucose and further medical treatment for hyperglycaemia as appropriate.
Primary study outcome: Incidence of large for gestational age infants.
Sample size: A sample size of 682 women will be sufficient to show a 50% reduction in the risk of large for gestational age infants (alpha 0.05 two-tailed, 80% power, 4% loss to follow up) from 14% to 7% with dietary and lifestyle advice and treatment.
Discussion
A conclusive trial outcome will provide reliable evidence of relevance for the care of women with borderline glucose intolerance in pregnancy and their infants.
Trial registration
Australian New Zealand Clinical Trials Registry - ACTRN12607000174482
doi:10.1186/1471-2393-12-106
PMCID: PMC3506505  PMID: 23046499
Borderline gestational diabetes; Gestational diabetes mellitus; Randomised controlled trial; Diet; Lifestyle; Large for gestational age
18.  Conflict of Interest Policies for Organizations Producing a Large Number of Clinical Practice Guidelines 
PLoS ONE  2012;7(5):e37413.
Background
Conflict of interest (COI) of clinical practice guideline (CPG) sponsors and authors is an important potential source of bias in CPG development. The objectives of this study were to describe the COI policies for organizations currently producing a significant number of CPGs, and to determine if these policies meet 2011 Institute of Medicine (IOM) standards.
Methodology/Principal Findings
We identified organizations with five or more guidelines listed in the National Guideline Clearinghouse between January 1, 2009 and November 5, 2010. We obtained the COI policy for each organization from publicly accessible sources, most often the organization's website, and compared those polices to IOM standards related to COI. 37 organizations fulfilled our inclusion criteria, of which 17 (46%) had a COI policy directly related to CPGs. These COI policies varied widely with respect to types of COI addressed, from whom disclosures were collected, monetary thresholds for disclosure, approaches to management, and updating requirements. Not one organization's policy adhered to all seven of the IOM standards that were examined, and nine organizations did not meet a single one of the standards.
Conclusions/Significance
COI policies among organizations producing a large number of CPGs currently do not measure up to IOM standards related to COI disclosure and management. CPG developers need to make significant improvements in these policies and their implementation in order to optimize the quality and credibility of their guidelines.
doi:10.1371/journal.pone.0037413
PMCID: PMC3358298  PMID: 22629391
19.  The Changes in Maternal Mortality in 1000 Counties in Mid-Western China by a Government-Initiated Intervention 
PLoS ONE  2012;7(5):e37458.
Background
Since 2000, the Chinese government has implemented an intervention program to reduce maternal mortality and eliminate neonatal tetanus in accordance with the Millennium Development Goals 5. To assess the effectiveness of this intervention program, we analyzed the level, trend and reasons defining the maternal mortality ratio (MMR) in the 1,000 priority counties before and after implementation of the intervention between 1999 and 2007.
Methodology/Principal Findings
The data was obtained from the National Maternal and Child Health Routine Reporting System. The intervention included providing basic and emergency obstetric equipment and supplies to local medical hospitals, and also included providing professional training to local obstetric doctors, development of obstetric emergency centers and “green channel” express referral networks, reducing or waiving the cost of hospital delivery, and conducting community health education. Based on the initiation time of the intervention and the level of poverty, 1,000 counties, containing a total population of 300 million, were categorized into three groups. MMR significantly decreased by about 50%, with an average reduction rate of 9.24%, 16.06%, and 18.61% per year in the three county groups, respectively. The hospital delivery rate significantly increased. Obstetric hemorrhage was the leading cause of maternal deaths and significantly declined, with an average decrease in the MMR of 11.25%, 18.03%, and 24.90% per year, respectively. The magnitude of the MMR, the average reduction rate of the MMR, and the occurrence of the leading causes of death were closely associated with the percentage of poverty.
Conclusions/Significance
The intervention program implemented by the Chinese government has significantly reduced the MMR in mid-western China, suggesting that well-targeted interventions could be an efficient strategy to reducing MMR in resource-poor areas. Reduction of the MMR not only depends on conducting proven interventions, but also relies on economic development in rural areas with a high burden of maternal death.
doi:10.1371/journal.pone.0037458
PMCID: PMC3357422  PMID: 22629398
20.  Evaluating Fidelity in Home-Visiting Programs a Qualitative Analysis of 1058 Home Visit Case Notes from 105 Families 
PLoS ONE  2012;7(5):e36915.
Objective
Implementation fidelity is a key issue in home-visiting programs as it determines a program’s effectiveness in accomplishing its original goals. This paper seeks to evaluate fidelity in a 27-month program addressing maternal and child health which took place in France between 2006 and 2011.
Method
To evaluate implementation fidelity, home visit case notes were analyzed using thematic qualitative and computer-assisted linguistic analyses.
Results
During the prenatal period, home visitors focused on the social components of the program. Visitors discussed the physical changes in pregnancy, and psychological and social environment issues. Discussing immigration, unstable employment and financial related issues, family relationships and dynamics and maternity services, while not expected, were found in case notes. Conversely, health during pregnancy, early child development and postpartum mood changes were not identified as topics within the prenatal case notes. During the postnatal period, most components of the intervention were addressed: home visitors observed the mother’s adaptation to the baby; routine themes such as psychological needs and medical-social networks were evaluated; information on the importance of social support and on adapting the home environment was given; home visitors counseled on parental authority, and addressed mothers’ self-esteem issues; finally, they helped to find child care, when necessary. Some themes were not addressed or partially addressed: health education, child development, home environment, mother’s education plans and personal routine, partner support and play with the child. Other themes were not expected, but found in the case notes: social issues, mother-family relationship, relation with services, couple issues, quality of maternal behavior and child’s language development.
Conclusions
In this program, home visitors experienced difficulties addressing some of the objectives because they gave precedence to the families“ urgent needs. This research stresses the importance of training home visitors to adapt the intervention to the social, psychological and health needs of families.
doi:10.1371/journal.pone.0036915
PMCID: PMC3356353  PMID: 22629341
21.  Improving Quality of Care for Maternal and Newborn Health: Prospective Pilot Study of the WHO Safe Childbirth Checklist Program 
PLoS ONE  2012;7(5):e35151.
Background
Most maternal deaths, intrapartum-related stillbirths, and newborn deaths in low income countries are preventable but simple, effective methods for improving safety in institutional births have not been devised. Checklist-based interventions aid management of complex or neglected tasks and have been shown to reduce harm in healthcare. We hypothesized that implementation of the WHO Safe Childbirth Checklist program, a novel childbirth safety program for institutional births incorporating a 29-item checklist, would increase delivery of essential childbirth practices linked with improved maternal and perinatal health outcomes.
Methods and Findings
A pilot, pre-post-intervention study was conducted in a sub-district level birth center in Karnataka, India between July and December 2010. We prospectively observed health workers that attended to women and newborns during 499 consecutively enrolled birth events and compared these with observed practices during 795 consecutively enrolled birth events after the introduction of the WHO Safe Childbirth Checklist program. Twenty-nine essential practices that target the major causes of childbirth-related mortality, such as hand hygiene and uterotonic administration, were evaluated. The primary end point was the average rate of successful delivery of essential childbirth practices by health workers. Delivery of essential childbirth-related care practices at each birth event increased from an average of 10 of 29 practices at baseline (95%CI 9.4, 10.1) to an average of 25 of 29 practices afterwards (95%CI 24.6, 25.3; p<0.001). There was significant improvement in the delivery of 28 out of 29 individual practices. No adverse outcomes relating to the intervention occurred. Study limitations are the pre-post design, potential Hawthorne effect, and focus on processes of care versus health outcomes.
Conclusions
Introduction of the WHO Safe Childbirth Checklist program markedly improved delivery of essential safety practices by health workers. Future study will determine if this program can be implemented at scale and improve health outcomes.
doi:10.1371/journal.pone.0035151
PMCID: PMC3353951  PMID: 22615733
22.  Women's Education Level, Maternal Health Facilities, Abortion Legislation and Maternal Deaths: A Natural Experiment in Chile from 1957 to 2007 
PLoS ONE  2012;7(5):e36613.
Background
The aim of this study was to assess the main factors related to maternal mortality reduction in large time series available in Chile in context of the United Nations' Millennium Development Goals (MDGs).
Methods
Time series of maternal mortality ratio (MMR) from official data (National Institute of Statistics, 1957–2007) along with parallel time series of education years, income per capita, fertility rate (TFR), birth order, clean water, sanitary sewer, and delivery by skilled attendants were analysed using autoregressive models (ARIMA). Historical changes on the mortality trend including the effect of different educational and maternal health policies implemented in 1965, and legislation that prohibited abortion in 1989 were assessed utilizing segmented regression techniques.
Results
During the 50-year study period, the MMR decreased from 293.7 to 18.2/100,000 live births, a decrease of 93.8%. Women's education level modulated the effects of TFR, birth order, delivery by skilled attendants, clean water, and sanitary sewer access. In the fully adjusted model, for every additional year of maternal education there was a corresponding decrease in the MMR of 29.3/100,000 live births. A rapid phase of decline between 1965 and 1981 (−13.29/100,000 live births each year) and a slow phase between 1981 and 2007 (−1.59/100,000 live births each year) were identified. After abortion was prohibited, the MMR decreased from 41.3 to 12.7 per 100,000 live births (−69.2%). The slope of the MMR did not appear to be altered by the change in abortion law.
Conclusion
Increasing education level appears to favourably impact the downward trend in the MMR, modulating other key factors such as access and utilization of maternal health facilities, changes in women's reproductive behaviour and improvements of the sanitary system. Consequently, different MDGs can act synergistically to improve maternal health. The reduction in the MMR is not related to the legal status of abortion.
doi:10.1371/journal.pone.0036613
PMCID: PMC3344918  PMID: 22574194
23.  Induction of Labor versus Expectant Management in Women with Preterm Prelabor Rupture of Membranes between 34 and 37 Weeks: A Randomized Controlled Trial 
PLoS Medicine  2012;9(4):e1001208.
In a randomized controlled trial David van der Ham and colleagues investigate induction of labor versus expectant management for women with preterm prelabor rupture of membranes.
Background
At present, there is insufficient evidence to guide appropriate management of women with preterm prelabor rupture of membranes (PPROM) near term.
Methods and Findings
We conducted an open-label randomized controlled trial in 60 hospitals in The Netherlands, which included non-laboring women with >24 h of PPROM between 34+0 and 37+0 wk of gestation. Participants were randomly allocated in a 1∶1 ratio to induction of labor (IoL) or expectant management (EM) using block randomization. The main outcome was neonatal sepsis. Secondary outcomes included mode of delivery, respiratory distress syndrome (RDS), and chorioamnionitis. Patients and caregivers were not blinded to randomization status. We updated a prior meta-analysis on the effect of both interventions on neonatal sepsis, RDS, and cesarean section rate.
From 1 January 2007 to 9 September 2009, 776 patients in 60 hospitals were eligible for the study, of which 536 patients were randomized. Four patients were excluded after randomization. We allocated 266 women (268 neonates) to IoL and 266 women (270 neonates) to EM. Neonatal sepsis occurred in seven (2.6%) newborns of women in the IoL group and in 11 (4.1%) neonates in the EM group (relative risk [RR] 0.64; 95% confidence interval [CI] 0.25 to 1.6). RDS was seen in 21 (7.8%, IoL) versus 17 neonates (6.3%, EM) (RR 1.3; 95% CI 0.67 to 2.3), and a cesarean section was performed in 36 (13%, IoL) versus 37 (14%, EM) women (RR 0.98; 95% CI 0.64 to 1.50). The risk for chorioamnionitis was reduced in the IoL group. No serious adverse events were reported.
Updating an existing meta-analysis with our trial results (the only eligible trial for the update) indicated RRs of 1.06 (95% CI 0.64 to 1.76) for neonatal sepsis (eight trials, 1,230 neonates) and 1.27 (95% CI 0.98 to 1.65) for cesarean section (eight trials, 1,222 women) for IoL compared with EM.
Conclusions
In women whose pregnancy is complicated by late PPROM, neither our trial nor the updated meta-analysis indicates that IoL substantially improves pregnancy outcomes compared with EM.
Trial registration
Current Controlled Trials ISRCTN29313500
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Most pregnancies last around 40 weeks, but in industrialized countries, 5%–10% of babies are born before 37 weeks of gestation (gestation is the period during which a baby develops in its mother's womb). Premature birth is a major cause of infant death in many developed countries, and preterm babies can also have short- and/or long-term health problems such as breathing problems, increased susceptibility to life-threatening infections, and learning and developmental disabilities. There are many reasons why some babies are born prematurely, but preterm prelabor rupture of the membranes (PPROM) accounts for 30%–40% of preterm deliveries. Inside the womb, the baby is held in a fluid-filled bag called the amniotic sac. The amniotic fluid cushions the baby, helps some of its organs develop, and protects both mother and baby from infection. The membranes that form the sac usually break at the start of labor (“water breaking”), but in PPROM, the membranes break before the baby is fully grown. PPROM increases the mother's risk of a womb infection called chorioamnionitis and the baby's risk of neonatal sepsis (blood infection), and can trigger early labor.
Why Was This Study Done?
There is currently no consensus on how to manage women whose membranes rupture between 34 and 37 weeks' gestation. Some guidelines recommend immediate induction of labor if PPROM occurs at or beyond 34 weeks' gestation. Others recommend that labor not be induced unless the mother develops signs of infection such as a high temperature or has not delivered her baby spontaneously by 37 weeks' gestation (expectant management). Before 34 weeks' gestation, expectant management is generally recommended. In this randomized controlled trial, the researchers compare the effects of induction of labor and of expectant management on the rate of neonatal sepsis (the proportion of babies that develop neonatal sepsis; the trial's primary outcome) and on secondary outcomes such as the rates of neonatal respiratory distress syndrome (RDS), cesarean section (surgical delivery), and chorioamnionitis in women with PPROM between 34 and 37 weeks' gestation. The researchers also undertake a meta-analysis of published trials on the effect of both interventions on pregnancy outcomes. A randomized controlled trial compares the effects of different interventions in groups of individuals chosen through the play of chance; meta-analysis is a statistical approach that combines the results of several trials.
What Did the Researchers Do and Find?
In the PPROM Expectant Management versus Induction of Labor (PRROMEXIL) trial, 532 non-laboring women with PPROM between 34 and 37 weeks' gestation were randomly assigned to either immediate induction of labor or expectant management. Neonatal sepsis occurred in seven babies born to women in the induction of labor group and in 11 babies born to women in the expectant management group. This difference was not statistically significant. That is, it could have happened by chance. Similarly, although more babies born to women in the induction of labor group than in the expectant management group developed RDS (21 and 17 babies, respectively), this difference was not significant. Cesarean section rates were similar in both intervention groups, but the risk of chorioamnionitis was slightly reduced in the induction of labor group compared to the expectant management group. Finally, the researchers' meta-analysis (which included these new results) found no significant differences in the risk of neonatal sepsis, RDS, or cesarean section associated with the two interventions.
What Do These Findings Mean?
These findings show that, compared to expectant management, induction of labor did not reduce the incidence of neonatal sepsis in pregnancies complicated by PPROM between 34 and 37 weeks' gestation. However, because fewer babies than expected born to the women in the expectant management group developed neonatal sepsis, this trial was underpowered. That is, too few women were enrolled in the trial to enable the detection of a small difference between the interventions in the neonatal sepsis rate. These findings also show that induction of labor did not substantially affect most of the secondary outcomes measured by the researchers. Given these results and those of their meta-analysis, the researchers conclude that, in women whose pregnancy is complicated by PPROM late in pregnancy, induction of labor does not substantially improve the outcome for either the woman or her baby compared to expectant management.
Additional Information
Please access these web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001208.
The March of Dimes, a nonprofit organization for pregnancy and baby health, provides information on preterm birth (in English and Spanish); its News Moms Need blog contains a post on PPROM
Tommy's is a nonprofit organization that funds research and provides information on the causes and prevention of miscarriage, premature birth, and stillbirth
The Royal College of Obstetricians and Gynaecologists guidelines on the diagnosis, investigation, and management of PPROM are available (in English and Russian)
Information about the PPROMEXIL trial is available
Personal stories about PPROM are available on the Austprem web site, a non-profit organization that provides information about prematurity and support for parents of premature babies in Australia
MedlinePlus provides links to other information on premature babies (in English and Spanish)
doi:10.1371/journal.pmed.1001208
PMCID: PMC3335867  PMID: 22545024
24.  The Effect of Maternal Multiple Micronutrient Supplementation on Cognition and Mood during Pregnancy and Postpartum in Indonesia: A Randomized Trial 
PLoS ONE  2012;7(3):e32519.
Maternal caregiving capacity, which is affected in part by cognition and mood, is crucial for the health of mothers and infants. Few interventions aim to improve maternal and infant health through improving such capacity. Multiple micronutrient (MMN) supplementation may improve maternal cognition and mood, since micronutrients are essential for brain function. We assessed mothers who participated in the Supplementation with Multiple Micronutrients Intervention Trial (SUMMIT), a double-blind cluster-randomized trial in Indonesia comparing MMN supplementation to iron and folic acid (IFA) during pregnancy and until three months postpartum. We adapted a set of well-studied tests of cognition, motor dexterity, and mood to the local context and administered them to a random sample of 640 SUMMIT participants after an average of 25 weeks (SD = 9) of supplementation. Analysis was by intention to treat. Controlling for maternal age, education, and socio-economic status, MMN resulted in a benefit of 0.12 SD on overall cognition, compared to IFA (95%CI 0.03–0.22, p = .010), and a benefit of 0.18 SD on reading efficiency (95%CI 0.02–0.35, p = .031). Both effects were found particularly in anemic (hemoglobin<110 g/L; overall cognition: B = 0.20, 0.00–0.41, p = .055; reading: B = 0.40, 0.02–0.77, p = .039) and undernourished (mid-upper arm circumference<23.5 cm; overall cognition: B = 0.33, 0.07–0.59, p = .020; reading: B = 0.65, 0.19–1.12, p = .007) mothers. The benefit of MMN on overall cognition was equivalent to the benefit of one year of education for all mothers, to two years of education for anemic mothers, and to three years of education for undernourished mothers. No effects were found on maternal motor dexterity or mood. This is the first study demonstrating an improvement in maternal cognition with MMN supplementation. This improvement may increase the quality of care mothers provide for their infants, potentially partly mediating effects of maternal MMN supplementation on infant health and survival. The study is registered as an International Standard Randomized Controlled Trial, number ISRCTN34151616. http://www.controlled-trials.com/ISRCTN34151616
doi:10.1371/journal.pone.0032519
PMCID: PMC3299672  PMID: 22427850
25.  Care Seeking for Neonatal Illness in Low- and Middle-Income Countries: A Systematic Review 
PLoS Medicine  2012;9(3):e1001183.
Hadley Herbert and colleagues systematically review newborn care-seeking behaviors by caregivers in low- and middle-income countries.
Background
Despite recent achievements to reduce child mortality, neonatal deaths continue to remain high, accounting for 41% of all deaths in children under five years of age worldwide, of which over 90% occur in low- and middle-income countries (LMICs). Infections are a leading cause of death and limitations in care seeking for ill neonates contribute to high mortality rates. As estimates for care-seeking behaviors in LMICs have not been studied, this review describes care seeking for neonatal illnesses in LMICs, with particular attention to type of care sought.
Methods and Findings
We conducted a systematic literature review of studies that reported the proportion of caregivers that sought care for ill or suspected ill neonates in LMICs. The initial search yielded 784 studies, of which 22 studies described relevant data from community household surveys, facility-based surveys, and intervention trials. The majority of studies were from South Asia (n = 17/22), set in rural areas (n = 17/22), and published within the last 4 years (n = 18/22). Of the 9,098 neonates who were ill or suspected to be ill, 4,320 caregivers sought some type of care, including care from a health facility (n = 370) or provider (n = 1,813). Care seeking ranged between 10% and 100% among caregivers with a median of 59%. Care seeking from a health care provider yielded a similar range and median, while care seeking at a health care facility ranged between 1% and 100%, with a median of 20%. Care-seeking estimates were limited by the few studies conducted in urban settings and regions other than South Asia. There was a lack of consistency regarding illness, care-seeking, and care provider definitions.
Conclusions
There is a paucity of data regarding newborn care-seeking behaviors; in South Asia, care seeking is low for newborn illness, especially in terms of care sought from health care facilities and medically trained providers. There is a need for representative data to describe care-seeking patterns in different geographic regions and better understand mechanisms to enhance care seeking during this vulnerable time period.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Worldwide around 3.3 million babies die within their first month of life every year. While the global neonatal mortality rate has declined by 28% between 1990 and 2009 (from 33.2 deaths per 1,000 livebirths to 23.9), the proportion of under-five child deaths that are now in the neonatal period has increased in all regions of the world and currently stands at 41%. Of these deaths, over 90% occur in low- and middle-income countries (LMICs), making the risk of death in the neonatal period in LMICs more than six times higher than in high-income countries. In LMIC settings most babies are born at home so inappropriate and delayed care seeking can contribute substantially to neonatal mortality. Infection causes over a quarter of all deaths in neonates, but in LMICs diagnosis is often based on nonspecific clinical signs, which may delay the provision of care.
Why Was This Study Done?
In order to improve neonatal survival in LMICs, health care facilities and providers must not only be available and accessible but a baby's caregiver, often a parent or other family member, must also recognize that the baby is ill and seek help. To address this problem with effective strategies, an understanding is needed of the patterns of care-seeking behavior by babies' caregivers in seeking help from health-care facilities or providers. In this study, the researchers explored the extent and nature of care-seeking behaviors by the caregivers of ill babies in LMIC settings.
What Did the Researchers Do and Find?
Using multiple databases, the researchers conducted a comprehensive review up until October 2011 of all relevant studies including those that had not been formally published. Using specific criteria, the researchers then identified 22 appropriate studies (out of a possible 784) and recorded the same information from each study, including the number of neonates with illness or suspected illness, the number of care providers who sought care, and where care was sought. They also assessed the quality of each included study (the majority of which were from rural areas in South Asia) on the basis of a validated method for reviewing intervention effectiveness. The researchers found that the definitions of neonatal illness and care-seeking behavior varied considerably between studies or were not defined at all. Because of these inherent study differences it was not possible to statistically combine the results from the identified studies using a technique called meta-analysis, instead the researchers reported literature estimates and described their findings narratively.
The researchers' analysis included 9,098 neonates who were identified in community-based studies as being ill or suspected of being ill and a total of 4,320 related care-seeking events: care seeking ranged between 10% and 100% among caregivers including seeking care from a health facility (370) or from a health provider (1,813). Furthermore, between 4% to 100% of caregivers sought care from a trained medical provider and 4% to 48% specified receiving care at a health care facility: caregivers typically sought help from primary health care, secondary health care, and pharmacies and some from an unqualified health provider. The researchers also identified seven community-based intervention studies that included interventions such as essential newborn care, birth preparedness, and illness recognition, where all showed an increase in care seeking following the intervention.
What Do These Findings Mean?
These findings highlight the lack of a standardized and consistent approach to neonate care-seeking behaviors described in the literature. However, despite the large variations of results, care seeking for newborn illnesses in LMICs appears to be low in general and remains a key challenge to improving neonatal mortality. Global research efforts to define, understand, and address care seeking, may help to reduce the global burden of neonatal mortality. However, to achieve sustainable improvements in neonatal survival, changes are needed to both increase the demand for newborn care and strengthen health care systems to improve access to, and quality of, care. This review also shows that there is a role for interventions within the community to encourage appropriate and timely care seeking. Finally, by addressing the inconsistencies and establishing standardized terms to identify barriers to care, future studies may be able to better generalize the factors and delays that influence neonatal care seeking.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001183.
A recent PLoS Medicine study has the latest figures on neonatal mortality worldwide
UNICEF provides information about progress toward United Nations Millennium Development Goal 4
UNICEF also has information about neonatal mortality
The United Nations Population Fund has information on home births
doi:10.1371/journal.pmed.1001183
PMCID: PMC3295826  PMID: 22412355

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