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1.  A cohort study of Plasmodium falciparum malaria in pregnancy and associations with uteroplacental blood flow and fetal anthropometrics in Kenya 
To use ultrasound to explore the impact of malaria in pregnancy on fetal growth and newborn outcomes among a cohort of women enrolled in an intermittent presumptive treatment in pregnancy (IPTp) with sulfadoxine/pyrimethamine (SP) program in coastal Kenya.
Enrolled women were tested for malaria at first prenatal care visit, and physical and ultrasound examinations were performed. In total, 477 women who had term, live births had malaria tested at delivery and their birth outcomes assessed, and were included in the study.
Peripheral malaria was detected via polymerase chain reaction among 10.9% (n=87) at first prenatal care visit and 8.8% (n=36) at delivery. Insecticide-treated bed nets (ITNs) were used by 73.6% (n=583) and were associated with decreased malaria risk. There was a trend for impaired fetal growth and placental blood flow in malaria-infected women in the second trimester, but not later in pregnancy. Among women with low body mass index (BMI), malaria was associated with reduced birth weight (P=0.04); anthropometric measures were similar otherwise.
With IPTp-SP and ITNs, malaria in pregnancy was associated with transient differences in utero, and reduced birth weight was restricted to those with low BMI.
PMCID: PMC4327864  PMID: 24792408
Fetal growth; Malaria in pregnancy; Sub-Saharan Africa
2.  Data quality monitoring and performance metrics of a prospective, population-based observational study of maternal and newborn health in low resource settings 
Reproductive Health  2015;12(Suppl 2):S2.
To describe quantitative data quality monitoring and performance metrics adopted by the Global Network’s (GN) Maternal Newborn Health Registry (MNHR), a maternal and perinatal population-based registry (MPPBR) based in low and middle income countries (LMICs).
Ongoing prospective, population-based data on all pregnancy outcomes within defined geographical locations participating in the GN have been collected since 2008. Data quality metrics were defined and are implemented at the cluster, site and the central level to ensure data quality. Quantitative performance metrics are described for data collected between 2010 and 2013.
Delivery outcome rates over 95% illustrate that all sites are successful in following patients from pregnancy through delivery. Examples of specific performance metric reports illustrate how both the metrics and reporting process are used to identify cluster-level and site-level quality issues and illustrate how those metrics track over time. Other summary reports (e.g. the increasing proportion of measured birth weight compared to estimated and missing birth weight) illustrate how a site has improved quality over time.
High quality MPPBRs such as the MNHR provide key information on pregnancy outcomes to local and international health officials where civil registration systems are lacking. The MNHR has measures in place to monitor data collection procedures and improve the quality of data collected. Sites have increasingly achieved acceptable values of performance metrics over time, indicating improvements in data quality, but the quality control program must continue to evolve to optimize the use of the MNHR to assess the impact of community interventions in research protocols in pregnancy and perinatal health.
Trial registration number
PMCID: PMC4464020  PMID: 26062714
data monitoring; data quality; maternal health; newborn health; perinatal registry; metrics; low-income countries
3.  Lost to follow-up among pregnant women in a multi-site community based maternal and newborn health registry: a prospective study 
Reproductive Health  2015;12(Suppl 2):S4.
It is important when conducting epidemiologic studies to closely monitor lost to follow up (LTFU) rates. A high LTFU rate may lead to incomplete study results which in turn can introduce bias to the trial or study, threatening the validity of the findings. There is scarce information on LTFU in prospective community-based perinatal epidemiological studies. This paper reports the rates of LTFU, describes socio-demographic characteristics, and pregnancy/delivery outcomes of mothers LTFU in a large community-based pregnancy registry study.
Data were from a prospective, population-based observational study of the Global Network for Women's and Children's Health Research Maternal Newborn Health Registry (MNHR). This is a multi-centre, international study in which pregnant women were enrolled in mid-pregnancy, followed through parturition and 42 days post-delivery. Risk for LTFU was calculated within a 95%CI.
A total of 282,626 subjects were enrolled in this study, of which 4,893 were lost to follow-up. Overall, there was a 1.7% LTFU to follow up rate. Factors associated with a higher LTFU included mothers who did not know their last menstrual period (RR 2.2, 95% CI 1.1, 4.4), maternal age of < 20 years (RR 1.2, 95% CI 1.1, 1.3), women with no formal education (RR 1.2, 95% CI 1.1, 1.4), and attending a government clinic for antenatal care (RR 2.0, 95% CI 1.4, 2.8). Post-natal factors associated with a higher LTFU rate included a newborn with feeding problems (RR 1.6, 94% CI 1.2, 2.2).
The LTFU rate in this community-based registry was low (1.7%). Maternal age, maternal level of education, pregnancy status at enrollment and using a government facility for ANC are factors associated with being LTFU. Strategies to ensure representation and high retention in community studies are important to informing progress toward public health goals.
Trial registration
Registration at the (ID# NCT01073475).
PMCID: PMC4464022  PMID: 26062899
Community based registry; maternal and newborn registry; lost to follow up rate; maternal socio demographic characteristics; pregnancy outcomes
4.  Stillbirth rates in low-middle income countries 2010 - 2013: a population-based, multi-country study from the Global Network 
Reproductive Health  2015;12(Suppl 2):S7.
Stillbirth rates remain nearly ten times higher in low-middle income countries (LMIC) than high income countries. In LMIC, where nearly 98% of stillbirths worldwide occur, few population-based studies have documented characteristics or care for mothers with stillbirths. Non-macerated stillbirths, those occurring around delivery, are generally considered preventable with appropriate obstetric care.
We undertook a prospective, population-based observational study of all pregnant women in defined geographic areas across 7 sites in low-resource settings (Kenya, Zambia, India, Pakistan, Guatemala and Argentina). Staff collected demographic and health care characteristics with outcomes obtained at delivery.
From 2010 through 2013, 269,614 enrolled women had 272,089 births, including 7,865 stillbirths. The overall stillbirth rate was 28.9/1000 births, ranging from 13.6/1000 births in Argentina to 56.5/1000 births in Pakistan. Stillbirth rates were stable or declined in 6 of the 7 sites from 2010-2013, only increasing in Pakistan. Less educated, older and women with less access to antenatal care were at increased risk of stillbirth. Furthermore, women not delivered by a skilled attendant were more likely to have a stillbirth (RR 2.8, 95% CI 2.2, 3.5). Compared to live births, stillbirths were more likely to be preterm (RR 12.4, 95% CI 11.2, 13.6). Infants with major congenital anomalies were at increased risk of stillbirth (RR 9.1, 95% CI 7.3, 11.4), as were multiple gestations (RR 2.8, 95% CI 2.4, 3.2) and breech (RR 3.0, 95% CI 2.6, 3.5). Altogether, 67.4% of the stillbirths were non-macerated. 7.6% of women with stillbirths had cesarean sections, with obstructed labor the primary indication (36.9%).
Stillbirth rates were high, but with reductions in most sites during the study period. Disadvantaged women, those with less antenatal care and those delivered without a skilled birth attendant were at increased risk of delivering a stillbirth. More than two-thirds of all stillbirths were non-macerated, suggesting potentially preventable stillbirth. Additionally, 8% of women with stillbirths were delivered by cesarean section. The relatively high rate of cesarean section among those with stillbirths suggested that this care was too late or not of quality to prevent the stillbirth; however, further research is needed to evaluate the quality of obstetric care, including cesarean section, on stillbirth in these low resource settings.
Study registration (ID# NCT01073475)
PMCID: PMC4464024  PMID: 26063292
Stillbirth; low-middle income countries; obstetric care
5.  Institutional deliveries and perinatal and neonatal mortality in Southern and Central India 
Reproductive Health  2015;12(Suppl 2):S13.
Skilled birth attendance and institutional delivery have been advocated for reducing maternal, perinatal and neonatal mortality (PMR and NMR). India has successfully implemented various strategies to promote skilled attendance and incentivize institutional deliveries in the last 5 years.
The study evaluates the trends in institutional delivery, PMR, NMR, and their risk factors in two Eunice Kennedy Shriver NICHD Global Network for Women’s and Children’s Health Research sites, in Belgaum and Nagpur, India, between January 2010 and December 2013.
Descriptive data stratified by level of delivery care and key risk factors were analyzed for 36 geographic clusters providing 48 months of data from a prospective, population-based surveillance system that registers all pregnant permanent residents in the study area, and their pregnancy outcomes irrespective of where they deliver. Log binomial models with generalized estimating equations to control for correlation of clustered observations were used to test the trends significance
64,803 deliveries were recorded in Belgaum and 39,081 in Nagpur. Institutional deliveries increased from 92.6% to 96.1% in Belgaum and from 89.5% to 98.6% in Nagpur (both p<0.0001); hospital rates increased from 63.4% to 71.0% (p=0.002) and from 63.1% to 72.0% (p<0.0001), respectively. PMR declined from 41.3 to 34.6 (p=0.008) deaths per 1,000 births in Belgaum and from 47.4 to 40.8 (p=0.09) in Nagpur. Stillbirths also declined, from 22.5 to 16.3 per 1,000 births in Belgaum and from 29.3 to 21.1 in Nagpur (both p=0.002). NMR remained unchanged.
Significant increases in institutional deliveries, particularly in hospitals, were accompanied by reductions in stillbirths and PMR, but not by NMR.
PMCID: PMC4464025  PMID: 26063586
Perinatal mortality; stillbirth; neonatal mortality; institutional delivery; household surveillance; India
6.  Adverse maternal and perinatal outcomes in adolescent pregnancies: The Global Network’s Maternal Newborn Health Registry study 
Reproductive Health  2015;12(Suppl 2):S8.
Adolescent girls between 15 and 19 years give birth to around 16 million babies each year, around 11% of births worldwide. We sought to determine whether adolescent mothers are at higher risk of maternal and perinatal adverse outcomes compared with mothers aged 20–24 years in a prospective, population-based observational study of newborn outcomes in low resource settings.
We undertook a prospective, population-based multi-country research study of all pregnant women in defined geographic areas across 7 sites in six low-middle income countries (Kenya, Zambia, India, Pakistan, Guatemala and Argentina). The study population for this analysis was restricted to women aged 24 years or less, who gave birth to infants of at least 20 weeks’ gestation and 500g or more. We compared adverse pregnancy maternal and perinatal outcomes among pregnant adolescents 15-19 years, <15 years, and adults 20-24 years.
A total of 269,273 women were enrolled from January 2010 to December 2013. Of all pregnancies 11.9% (32,097/269,273) were in adolescents 15-19 years, while 0.14% (370/269,273) occurred among girls <15 years. Pregnancy among adolescents 15-19 years ranged from 2% in Pakistan to 26% in Argentina, and adolescent pregnancies <15 year were only observed in sub-Saharan Africa and Latin America. Compared to adults, adolescents did not show increased risk of maternal adverse outcomes. Risks of preterm birth and LBW were significantly higher among both early and older adolescents, with the highest risks observed in the <15 years group. Neonatal and perinatal mortality followed a similar trend in sub-Saharan Africa and Latin America, with the highest risk in early adolescents, although the differences in this age group were not significant. However, in South Asia the risks of neonatal and perinatal death were not different among adolescents 15-19 years compared to adults.
This study suggests that pregnancy among adolescents is not associated with worse maternal outcomes, but is associated with worse perinatal outcomes, particularly in younger adolescents. However, this may not be the case in regions like South Asia where there are decreasing rates of adolescent pregnancies, concentrated among older adolescents. The increased risks observed among adolescents seems more likely to be associated with biological immaturity, than with socio-economic factors, inadequate antenatal or delivery care.
Trial registration number
PMCID: PMC4464033  PMID: 26063350
adolescent pregnancy
7.  Risk factors for maternal death and trends in maternal mortality in low- and middle-income countries: a prospective longitudinal cohort analysis 
Reproductive Health  2015;12(Suppl 2):S5.
Because large, prospective, population-based data sets describing maternal outcomes are typically not available in low- and middle-income countries, it is difficult to monitor maternal mortality rates over time and to identify factors associated with maternal mortality. Early identification of risk factors is essential to develop comprehensive intervention strategies preventing pregnancy-related complications. Our objective was to describe maternal mortality rates in a large, multi-country dataset and to determine maternal, pregnancy-related, delivery and postpartum characteristics that are associated with maternal mortality.
We collected data describing all pregnancies from 2010 to 2013 among women enrolled in the multi-national Global Network for Women’s and Children’s Health Research Maternal and Neonatal Health Registry (MNHR). We reported the proportion of mothers who died per pregnancy and the maternal mortality ratio (MMR). Generalized linear models were used to evaluate the relationship of potential medical and social factors and maternal mortality and to develop point and interval estimates of relative risk associated with these factors. Generalized estimating equations were used to account for the correlation of outcomes within cluster to develop appropriate confidence intervals.
We recorded 277,736 pregnancies and 402 maternal deaths for an MMR of 153/100,000 live births. We observed an improvement in the total MMR from 166 in 2010 to 126 in 2013. The MMR in Latin American sites (91) was lower than the MMR in Asian (178) and African sites (125). When adjusted for study site and the other variables, no formal education (RR 3.2 [1.5, 6.9]), primary education only (RR 3.4 [1.6, 7.5]), secondary education only (RR 2.5 [1.1, 5.7]), lack of antenatal care (RR 1.8 [1.2, 2.5]), caesarean section delivery (RR 1.9 [1.3, 2.8]), hemorrhage (RR 3.3 [2.2, 5.1]), and hypertensive disorders (RR 7.4 [5.2, 10.4]) were associated with higher risks of death.
The MNHR identified preventable causes of maternal mortality in diverse settings in low- and middle-income countries. The MNHR can be used to monitor public health strategies and determine their association with reducing maternal mortality.
Trial Registration NCT01073475
PMCID: PMC4464034  PMID: 26062992
8.  Maternal and newborn outcomes in Pakistan compared to other low and middle income countries in the Global Network’s Maternal Newborn Health Registry: an active, community-based, pregnancy surveillance mechanism 
Reproductive Health  2015;12(Suppl 2):S15.
Despite global improvements in maternal and newborn health (MNH), maternal, fetal and newborn mortality rates in Pakistan remain stagnant. Using data from the Global Network’s Maternal Newborn Health Registry (MNHR) the objective of this study is to compare the rates of maternal mortality, stillbirth and newborn mortality and levels of putative risk factors between the Pakistani site and those in other countries.
Using data collected through a multi-site, prospective, ongoing, active surveillance system to track pregnancies and births in communities in discrete geographical areas in seven sites across six countries including Pakistan, India, Kenya, Zambia, Guatemala and Argentina from 2010 to 2013, the study compared MNH outcomes and risk factors. The MNHR captures more than 60,000 deliveries annually across all sites with over 10,000 of them in Thatta, Pakistan.
The Pakistan site had a maternal mortality ratio almost three times that of the other sites (313/100,000 vs 116/100,000). Stillbirth (56.5 vs 22.9/1000 births), neonatal mortality (50.0 vs 20.7/1000 livebirths) and perinatal mortality rates (95.2/1000 vs 39.0/1000 births) in Thatta, Pakistan were more than twice those of the other sites. The Pakistani site is the only one in the Global Network where maternal mortality increased (from 231/100,000 to 353/100,000) over the study period and fetal and neonatal outcomes remained stagnant. The Pakistan site lags behind other sites in maternal education, high parity, and appropriate antenatal and postnatal care. However, facility delivery and skilled birth attendance rates were less prominently different between the Pakistani site and other sites, with the exception of India. The difference in the fetal and neonatal outcomes between the Pakistani site and the other sites was most pronounced amongst normal birth weight babies.
The increase in maternal mortality and the stagnation of fetal and neonatal outcomes from 2010 to 2013 indicates that current levels of antenatal and newborn care interventions in Thatta, Pakistan are insufficient to protect against poor maternal and neonatal outcomes. Delivery care in the Pakistani site, while appearing quantitatively equivalent to the care in sites in Africa, is less effective in saving the lives of women and their newborns. By the metrics available from this study, the quality of obstetric and neonatal care in the site in Pakistan is poor.
Trial registration
The study is registered at [NCT01073475].
PMCID: PMC4464035  PMID: 26062610
Pakistan; maternal mortality; stillbirth; neonatal mortality
9.  A prospective observational description of frequency and timing of antenatal care attendance and coverage of selected interventions from sites in Argentina, Guatemala, India, Kenya, Pakistan and Zambia 
Reproductive Health  2015;12(Suppl 2):S12.
The Global Network for Women’s and Children’s Health Research is one of the largest international networks for testing and generating evidence-based recommendations for improvement of maternal-child health in resource-limited settings. Since 2009, Global Network sites in six low and middle-income countries have collected information on antenatal care practices, which are important as indicators of care and have implications for programs to improve maternal and child health. We sought to: (1) describe the quantity of antenatal care attendance over a four-year period; and (2) explore the quality of coverage for selected preventative, screening, and birth preparedness components.
The Maternal Newborn Health Registry (MNHR) is a prospective, population-based birth and pregnancy outcomes registry in Global Network sites, including: Argentina, Guatemala, India (Belgaum and Nagpur), Kenya, Pakistan, and Zambia. MNHR data from these sites were prospectively collected from January 1, 2010 – December 31, 2013 and analyzed for indicators related to quantity and patterns of ANC and coverage of key elements of recommended focused antenatal care. Descriptive statistics were generated overall by global region (Africa, Asia, and Latin America), and for each individual site.
Overall, 96% of women reported at least one antenatal care visit. Indian sites demonstrated the highest percentage of women who initiated antenatal care during the first trimester. Women from the Latin American and Indian sites reported the highest number of at least 4 visits. Overall, 88% of women received tetanus toxoid. Only about half of all women reported having been screened for syphilis (49%) or anemia (50%). Rates of HIV testing were above 95% in the Argentina, African, and Indian sites. The Pakistan site demonstrated relatively high rates for birth preparation, but for most other preventative and screening interventions, posted lower coverage rates as compared to other Global Network sites.
Results from our large, prospective, population-based observational study contribute important insight into regional and site-specific patterns for antenatal care access and coverage. Our findings indicate a quality and coverage gap in antenatal care services, particularly in regards to syphilis and hemoglobin screening. We have identified site-specific gaps in access to, and delivery of, antenatal care services that can be targeted for improvement in future research and implementation efforts.
Trial registration
Registration at (ID# NCT01073475)
PMCID: PMC4464209  PMID: 26063483
Maternal-newborn health; birth registry; antenatal care; Africa; Asia; Latin America; focused antenatal care; quality of care
10.  Rates and determinants of early initiation of breastfeeding and exclusive breast feeding at 42 days postnatal in six low and middle-income countries: A prospective cohort study 
Reproductive Health  2015;12(Suppl 2):S10.
Early initiation of breastfeeding after birth and exclusive breastfeeding through six months of age confers many health benefits for infants; both are crucial high impact, low-cost interventions. However, determining accurate global rates of these crucial activities has been challenging. We use population-based data to describe: (1) rates of early initiation of breastfeeding (defined as within 1 hour of birth) and of exclusive breastfeeding at 42 days post-partum; and (2) factors associated with failure to initiate early breastfeeding and exclusive breastfeeding at 42 days post-partum.
Prospectively collected data from women and their live-born infants enrolled in the Global Network’s Maternal and Newborn Health Registry between January 1, 2010-December 31, 2013 included women-infant dyads in 106 geographic areas (clusters) at 7 research sites in 6 countries (Kenya, Zambia, India [2 sites], Pakistan, Argentina and Guatemala). Rates and risk factors for failure to initiate early breastfeeding were investigated for the entire cohort and rates and risk factors for failure to maintain exclusive breastfeeding was assessed in a sub-sample studied at 42 days post-partum.
A total of 255,495 live-born women-infant dyads were included in the study. Rates and determinants for the exclusive breastfeeding sub-study at 42 days post-partum were assessed from among a sub-sample of 105,563 subjects. Although there was heterogeneity by site, and early initiation of breastfeeding after delivery was high, the Pakistan site had the lowest rates of early initiation of breastfeeding. The Pakistan site also had the highest rate of lack of exclusive breastfeeding at 42 days post-partum. Across all regions, factors associated with failure to initiate early breastfeeding included nulliparity, caesarean section, low birth weight, resuscitation with bag and mask, and failure to place baby on the mother’s chest after delivery. Factors associated with failure to achieve exclusive breastfeeding at 42 days varied across the sites. The only factor significant in all sites was multiple gestation.
In this large, prospective, population-based, observational study, rates of both early initiation of breastfeeding and exclusive breastfeeding at 42 days post-partum were high, except in Pakistan. Factors associated with these key breastfeeding indicators should assist with more effective strategies to scale-up these crucial public health interventions.
Trial registration
Registration at the website (ID# NCT01073475).
PMCID: PMC4464210  PMID: 26063291
Early initiation of breastfeeding; exclusive breastfeeding; neonatal mortality; global health; newborn
11.  The Global Network Maternal Newborn Health Registry: a multi-national, community-based registry of pregnancy outcomes 
Reproductive Health  2015;12(Suppl 2):S1.
The Global Network for Women's and Children's Health Research (Global Network) supports and conducts clinical trials in resource-limited countries by pairing foreign and U.S. investigators, with the goal of evaluating low-cost, sustainable interventions to improve the health of women and children. Accurate reporting of births, stillbirths, neonatal deaths, maternal mortality, and measures of obstetric and neonatal care is critical to efforts to discover strategies for improving pregnancy outcomes in resource-limited settings. Because most of the sites in the Global Network have weak registration within their health care systems, the Global Network developed the Maternal Newborn Health Registry (MNHR), a prospective, population-based registry of pregnancies at the Global Network sites to provide precise data on health outcomes and measures of care.
Pregnant women are enrolled in the MNHR if they reside in or receive healthcare in designated groups of communities within sites in the Global Network. For each woman, demographic, health characteristics and major outcomes of pregnancy are recorded. Data are recorded at enrollment, the time of delivery and at 42 days postpartum.
From 2010 through 2013 Global Network sites were located in Argentina, Guatemala, Belgaum and Nagpur, India, Pakistan, Kenya, and Zambia. During this period, 283,496 pregnant women were enrolled in the MNHR; this number represented 98.8% of all eligible women. Delivery data were collected for 98.8% of women and 42-day follow-up data for 98.4% of those enrolled. In this supplement, there are a series of manuscripts that use data gathered through the MNHR to report outcomes of these pregnancies.
Developing public policy and improving public health in countries with poor perinatal outcomes is, in part, dependent upon understanding the outcome of every pregnancy. Because the worst pregnancy outcomes typically occur in countries with limited health registration systems and vital records, alternative registration systems may prove to be highly valuable in providing data. The MNHR, an international, multicenter, population-based registry, assesses pregnancy outcomes over time in support of efforts to develop improved perinatal healthcare in resource-limited areas.
Study Registration: The Maternal Newborn Health Registry is registered at (ID# NCT01073475).
PMCID: PMC4464212  PMID: 26063166
registry; perinatal mortality; neonatal mortality; stillbirth; maternal mortality
12.  A prospective population-based study of maternal, fetal, and neonatal outcomes in the setting of prolonged labor, obstructed labor and failure to progress in low- and middle-income countries 
Reproductive Health  2015;12(Suppl 2):S9.
This population-based study sought to quantify maternal, fetal, and neonatal morbidity and mortality in low- and middle-income countries associated with obstructed labor, prolonged labor and failure to progress (OL/PL/FTP).
A prospective, population-based observational study of pregnancy outcomes was performed at seven sites in Argentina, Guatemala, India (2 sites, Belgaum and Nagpur), Kenya, Pakistan and Zambia. Women were enrolled in pregnancy and delivery and 6-week follow-up obtained to evaluate rates of OL/PL/FTP and outcomes resulting from OL/PL/FTP, including: maternal and delivery characteristics, maternal and neonatal morbidity and mortality and stillbirth.
Between 2010 and 2013, 266,723 of 267,270 records (99.8%) included data on OL/PL/FTP with an overall rate of 110.4/1000 deliveries that ranged from 41.6 in Zambia to 200.1 in Pakistan. OL/PL/FTP was more common in women aged <20, nulliparous women, more educated women, women with infants >3500g, and women with a BMI >25 (RR 1.4, 95% CI 1.3 – 1.5), with the suggestion of OL/PL/FTP being less common in preterm deliveries. Protective characteristics included parity of ≥3, having an infant <1500g, and having a BMI <18. Women with OL/PL/FTP were more likely to die within 42 days (RR 1.9, 95% CI 1.4 – 2.4), be infected (RR 1.8, 95% CI 1.5 – 2.2), and have hemorrhage antepartum (RR 2.8, 95% CI 2.1 – 3.7) or postpartum (RR 2.4, 95% CI 1.8 – 3.3). They were also more likely to have a stillbirth (RR 1.6, 95% CI 1.3 – 1.9), a neonatal demise at < 28 days (RR 1.9, 95% CI 1.6 – 2.1), or a neonatal infection (RR 1.2, 95% CI 1.1 – 1.3). As compared to operative vaginal delivery and cesarean section (CS), women experiencing OL/PL/FTP who gave birth vaginally were more likely to become infected, to have an infected neonate, to hemorrhage in the antepartum and postpartum period, and to die, have a stillbirth, or have a neonatal demise. Women with OL/PL/FTP were far more likely to deliver in a facility and be attended by a physician or other skilled provider than women without this diagnosis.
Women with OL/PL/FTP in the communities studied were more likely to be primiparous, younger than age 20, overweight, and of higher education, with an infant with birthweight of >3500g. Women with this diagnosis were more likely to experience a maternal, fetal, or neonatal death, antepartum and postpartum hemorrhage, and maternal and neonatal infection. They were also more likely to deliver in a facility with a skilled provider. CS may decrease the risk of poor outcomes (as in the case of antepartum hemorrhage), but unassisted vaginal delivery exacerbates all of the maternal, fetal, and neonatal outcomes evaluated in the setting of OL/PL/FTP.
PMCID: PMC4464213  PMID: 26063492
obstructed labor; maternal mortality; maternal morbidity; neonatal mortality; neonatal morbidity; stillbirth; sub-Saharan Africa
13.  Neonatal mortality and coverage of essential newborn interventions 2010 - 2013: a prospective, population-based study from low-middle income countries 
Reproductive Health  2015;12(Suppl 2):S6.
Approximately 3 million neonatal deaths occur each year worldwide. Simple interventions have been tested and found to be effective in reducing the neonatal mortality. In order to effectively implement public health interventions, it is important to know the rates of neonatal mortality and understand the contributing risk factors. Hence, this prospective, population-based, observational study was carried out to inform these needs.
The Global Network’s Maternal Newborn Health Registry was initiated in the seven sites in 2008. Registry administrators (RAs) attempt to identify and enroll all eligible women by 20 weeks gestation and collect basic health data, and outcomes after delivery and at 6 weeks post-partum. All study data were collected, reviewed, and edited by staff at each study site. The study was reviewed and approved by each sites’ ethics review committee.
Overall, the 7-day neonatal mortality rate (NMR) was 20.6 per 1000 live births and the 28-day NMR was 25.7 per 1000 live births. Higher neonatal mortality was associated with maternal age > 35 and <20 years relative to women 20-35 years of age. Preterm births were at increased risk of both early and 28-day neonatal mortality (RR 8.1, 95% CI 7.5-8.8 and 7.5, 95% CI 6.9-8.1) compared to term as were those with low birth weight (<2500g). Neonatal resuscitation rates were 4.8% for hospital deliveries compared to 0.9% for home births. In the hospital, 26.5% of deliveries were by cesarean section with an overall cesarean section rate of 12.5%. Neonatal mortality rates were highest in the Pakistan site and lowest in Argentina.
Using prospectively collected data with high follow up rates (99%), we documented characteristics associated with neonatal mortality. Low birth weight and prematurity are among the strongest predictors of neonatal mortality. Other risk factors for neonatal deaths included male gender, multiple gestation and major congenital anomalies. Breech presentation/transverse lie, and no antenatal care were also significant risk factors for neonatal death. Coverage of interventions varied by setting of delivery, with the overall population rate of most evidence-based interventions low. This study informs about risk factors for neonatal mortality which can serve to design strategies/interventions to reduce risk of neonatal mortality.
Trial registration
The trial is registered at Trial Registration: NCT01073475
PMCID: PMC4464215  PMID: 26063125
neonatal mortality; newborn care; risk factors
14.  Establishment of a Maternal Newborn Health Registry in the Belgaum District of Karnataka, India 
Reproductive Health  2015;12(Suppl 2):S3.
Pregnancy-related vital registration is important to inform policy to reduce maternal, fetal and newborn mortality, yet few systems for capturing accurate data are available in low-middle income countries where the majority of the mortality occurs. Furthermore, methods to effectively implement high-quality registration systems have not been described. The goal of creating the registry described in this paper was to inform public health policy makers about pregnancy outcomes in our district so that appropriate interventions to improve these outcomes could be undertaken and to position the district to be a leader in pregnancy-related public health research.
We created a prospective maternal and newborn health registry in Belgaum, Karnataka State, India. To initiate this registry, we worked with the Ministry of Health to first establish estimated birth rates and define the catchment areas of the clusters, working within the existing health system and primary health centers. We also undertook household surveys to identify women likely to become pregnant. We then implemented monitoring measures to ensure high quality and completeness of the maternal newborn health registry. All pregnant women in the catchment area were identified, consented and enrolled during pregnancy, with follow-up visits to ascertain pregnancy outcomes and mother/infant status at 42-days postpartum.
From 2008 through 2014, we demonstrated continued improvements in both the coverage for enrollment and accuracy of reporting pregnancy outcomes within the defined catchment area in Belgaum, India. Nearly 100% of women enrolled had follow-up at birth and 99% had 42-day follow-up. Furthermore, we facilitated earlier enrollment of women during pregnancy while achieving more timely follow-up and decreased time of reporting from the date of the pregnancy event.
We created a pregnancy-related registry which includes demographic data, risk factors, and outcomes allowing for high rates of ascertainment and follow-up while working within the existing health system. Understanding the elements of the system used to create the registry is important to improve the quality of the results. Tracking of pregnancies and their outcomes is an important step toward reducing maternal and perinatal mortality.
PMCID: PMC4464217  PMID: 26062791
India; pregnancy registration
15.  Postpartum contraceptive use and unmet need for family planning in five low-income countries 
Reproductive Health  2015;12(Suppl 2):S11.
During the post-partum period, most women wish to delay or prevent future pregnancies. Despite this, the unmet need for family planning up to a year after delivery is higher than at any other time. This study aims to assess fertility intention, contraceptive usage and unmet need for family planning amongst women who are six weeks postpartum, as well as to identify those at greatest risk of having an unmet need for family planning during this period.
Using the NICHD Global Network for Women’s and Children’s Health Research’s multi-site, prospective, ongoing, active surveillance system to track pregnancies and births in 100 rural geographic clusters in 5 countries (India, Pakistan, Zambia, Kenya and Guatemala), we assessed fertility intention and contraceptive usage at day 42 post-partum.
We gathered data on 36,687 women in the post-partum period. Less than 5% of these women wished to have another pregnancy within the year. Despite this, rates of modern contraceptive usage varied widely and unmet need ranged from 25% to 96%. Even amongst users of modern contraceptives, the uptake of the most effective long-acting reversible contraceptives (intrauterine devices) was low. Women of age less than 20 years, parity of two or less, limited education and those who deliver at home were at highest risk for having unmet need.
Six weeks postpartum, almost all women wish to delay or prevent a future pregnancy. Even in sites where early contraceptive adoption is common, there is substantial unmet need for family planning. This is consistently highest amongst women below the age of 20 years. Interventions aimed at increasing the adoption of effective contraceptive methods are urgently needed in the majority of sites in order to reduce unmet need and to improve both maternal and infant outcomes, especially amongst young women.
Study registration (ID# NCT01073475)
PMCID: PMC4464604  PMID: 26063346
Contraception; low-middle income countries; obstetric care; family planning
16.  Trends in perinatal deaths from 2010 to 2013 in the Guatemalan Western Highlands 
Reproductive Health  2015;12(Suppl 2):S14.
While progress has been made in reducing neonatal mortality in Guatemala, stillbirth and maternal mortality rates remain high, especially among the indigenous populations, which have among the highest adverse pregnancy-related mortality rates in Guatemala.
We conducted a prospective study in the Western Highlands of Guatemala from 2010 through 2013, enrolling women during pregnancy with follow-up through 42-days postpartum. All pregnant women were identified and enrolled by study staff in the clusters in the Chimaltenango region for which we had 4 years of data. Enrolment usually occurred during the antenatal period; women were also visited following delivery and 42-days postpartum to collect outcomes. Measures of antenatal and delivery care were also obtained.
Approximately four thousand women were enrolled annually (3,869 in 2010 to 4,570 in 2013). The stillbirth rate decreased significantly, from 22.0 per 1000 births (95% CI 16.6, 29.0) in 2010 to 16.7 (95% CI 13.5, 20.6) in 2013 (p-value 0.0223). The perinatal mortality rate decreased from 43.9 per 1,000 births (95% CI 36.0, 53.6) to 31.6 (95% CI 27.2, 36.7) (p-value 0.0003). The 28-day neonatal mortality rate decreased from 28.9 per 1000 live births (95% CI 25.2, 33.2) to 21.7 (95% CI 17.5, 26.9), p-value 0.0004. The maternal mortality rate was 134 per 100,000 in 2010 vs. 113 per 100,000 in 2013. Over the same period, hospital birth rates increased from 30.0 to 50.3%.
In a relatively short time period, significant improvements in neonatal, fetal and perinatal mortality were noted in an area of Guatemala with a history of poor pregnancy outcomes. These changes were temporally related to major increases in hospital-based delivery with skilled birth attendants, as well as improvements in the quality of delivery care, neonatal care, and prenatal care.
PMCID: PMC4464607  PMID: 26062407
17.  Research results from a registry supporting efforts to improve maternal and child health in low and middle income countries 
Reproductive Health  2015;12:54.
The National Institute of Child Health and Human Development created and continues to support the Global Network for Women's and Children's Health Research, a partnership between research institutions in the US and low-middle income countries. This commentary describes a series of 15 papers emanating from the Global Network’s Maternal and Newborn Health Registry. Using data from 2010 to 2013, the series of papers describe nearly 300,000 pregnancies in 7 sites in 6 countries – India (2 sites), Pakistan, Kenya, Zambia, Guatemala and Argentina. These papers cover a wide range of topics including several dealing with efforts made to ensure data quality, and others reporting on specific pregnancy outcomes including maternal mortality, stillbirth and neonatal mortality. Topics ranging from antenatal care, adolescent pregnancy, obstructed labor, factors associated with early initiation of breast feeding and maintenance of exclusive breast feeding and contraceptive usage are presented. In addition, case studies evaluating changes in mortality over time in 3 countries - India, Pakistan and Guatemala - are presented. In order to make progress in improving pregnancy outcomes in low-income countries, data of this quality are needed.
PMCID: PMC4451746  PMID: 26032486
18.  Bile acids in a multicenter, population-based case-control study of stillbirth 
We sought to compare bile acids in women with and without stillbirth in a population-based study.
The Stillbirth Collaborative Research Network conducted a multisite, population-based case-control study of stillbirth (fetal deaths ≥20 weeks). Maternal sera were obtained at the time of enrollment and frozen at −80° until assay for bile acids.
Assays were performed in 581 women with stillbirth and 1546 women with live births. Bile acid levels were slightly higher in women with stillbirth (geometric mean [95% confidence interval {CI}] = 3.2 [3.0–3.5]) compared to live births (2.9 [2.7–3.1], P = .0327). However, the difference was not significant after adjustment for baseline risk factors for stillbirth. The proportion of women with elevated levels (≥10 or ≥40 μmol/L) was similar in stillbirths and live births. Results were similar when the analysis was limited to subsets of stillbirths and live births. In women with stillbirths not associated with fetal anomalies or obstetric complications bile acid levels were higher than in women with term live births (geometric mean [95% CI] = 3.4 [3.0–3.8] vs 2.9 [2.7–3.0], P = .0152, unadjusted; P = .06, adjusted). However, a similar proportion of women in both groups had levels ≥10 mmol/L (10.7 vs 7.2%; odds ratio [OR], 1.54; 95% CI, 0.97–2.44; adjusted OR, 1.29; 95% CI, 0.78–2.15) and ≥40 μmol/L (1.7 vs 0.7%; OR, 2.58; 95% CI, 0.85–7.84; adjusted OR, 2.28; 95% CI, 0.79–6.56).
Our data do not support testing for bile acids in cases of stillbirth in the absence of clinical evidence of intrahepatic cholestasis of pregnancy.
PMCID: PMC4413928  PMID: 24215860
bile acids; cholestasis; stillbirth
19.  Theory-driven process evaluation of a complementary feeding trial in four countries 
Health Education Research  2014;29(2):297-305.
We conducted a theory-driven process evaluation of a cluster randomized controlled trial comparing two types of complementary feeding (meat versus fortified cereal) on infant growth in Guatemala, Pakistan, Zambia and the Democratic Republic of Congo. We examined process evaluation indicators for the entire study cohort (N = 1236) using chi-square tests to examine differences between treatment groups. We administered exit interviews to 219 caregivers and 45 intervention staff to explore why caregivers may or may not have performed suggested infant feeding behaviors. Multivariate regression analysis was used to determine the relationship between caregiver scores and infant linear growth velocity. As message recall increased, irrespective of treatment group, linear growth velocity increased when controlling for other factors (P < 0.05), emphasizing the importance of study messages. Our detailed process evaluation revealed few differences between treatment groups, giving us confidence that the main trial’s lack of effect to reverse the progression of stunting cannot be explained by differences between groups or inconsistencies in protocol implementation. These findings add to an emerging body of literature suggesting limited impact on stunting of interventions initiated during the period of complementary feeding in impoverished environments. The early onset and steady progression support the provision of earlier and comprehensive interventions.
PMCID: PMC3959202  PMID: 24399265
20.  A Color-Coded Tape for Uterine Height Measurement: A Tool to Identify Preterm Pregnancies in Low Resource Settings 
PLoS ONE  2015;10(3):e0117134.
Neonatal mortality associated with preterm birth can be reduced with antenatal corticosteroids (ACS), yet <10% of eligible pregnant women in low-middle income countries. The inability to accurately determine gestational age (GA) leads to under-identification of high-risk women who could receive ACS or other interventions. To facilitate better identification in low-resource settings, we developed a color-coded tape for uterine height (UH) measurement and estimated its accuracy identifying preterm pregnancies.
We designed a series of colored-coded tapes with segments corresponding to UH measurements for 20–23.6 weeks, 24.0–35.6 weeks, and >36.0 weeks GA. In phase 1, UH measurements were collected prospectively in the Democratic Republic of Congo, India and Pakistan, using distinct tapes to address variation across regions and ethnicities. In phase 2, we tested accuracy in 250 pregnant women with known GA from early ultrasound enrolled at prenatal clinics in Argentina, India, Pakistan and Zambia. Providers masked to the ultrasound GA measured UH. Receiver operating characteristics (ROC) analysis was conducted.
1,029 pregnant women were enrolled. In all countries the tapes were most effective identifying pregnancies between 20.0–35.6 weeks, compared to the other GAs. The ROC areas under the curves and 95% confidence intervals were: Argentina 0.69 (0.63, 0.74); Zambia 0.72 (0.66, 0.78), India 0.84 (0.80, 0.89), and Pakistan 0.83 (0.78, 0.87). The sensitivity and specificity (and 95% confidence intervals) for identifying pregnancies between 20.0–35.6 weeks, respectively, were: Argentina 87% (82%–92%) and 51% (42%–61%); Zambia 91% (86%–95%) and 50% (40%–60%); India 78% (71%–85%) and 89% (83%–94%); Pakistan 63% (55%–70%) and 94% (89%–99%).
We observed moderate-good accuracy identifying pregnancies ≤35.6 weeks gestation, with potential usefulness at the community level in low-middle income countries to facilitate the preterm identification and interventions to reduce preterm neonatal mortality. Further research is needed to validate these findings on a population basis.
PMCID: PMC4379082  PMID: 25822529
21.  Stillbirths and neonatal mortality as outcomes 
Several recent studies in low-resource countries have claimed that training in—and increased use of—newborn resuscitation resulted in reduced stillbirth rates. In the present article, we explore the ability of various types of birth attendant in some low-resource country locations to gather data that accurately differentiate a stillbirth from a live birth/early neonatal death. We conclude that, in many situations, it cannot be determined whether the infant was a stillbirth or a live birth/early neonatal death, and therefore the least-biased description of study outcomes includes a combined stillbirth and live birth/neonatal death outcome. However, because defining the burden of stillbirth and neonatal death is important from a public health perspective, every effort should be made, in low-income countries and elsewhere, to distinguish between stillbirths and live births/neonatal deaths and to report the results independently.
PMCID: PMC4349406  PMID: 24050480
Perinatal mortality; Resuscitation; Stillbirth
22.  Neonatal death in Low-Middle Income Countries: A Global Network Study 
American journal of perinatology  2012;29(8):649-656.
To determine population-based neonatal mortality rates in low and middle income countries and to examine gestational age, birth-weight and timing of death to assess the potentially preventable neonatal deaths.
A prospective observational study was conducted in communities in five low-income countries (Kenya, Zambia, Guatemala, India, and Pakistan) and one mid-income country (Argentina). Over a two-year period, all pregnant women in the study communities were enrolled by trained study staff and their infants followed to 28 days of age.
Between October 2009 and March 2011, 153,728 babies were delivered and followed through day 28. Neonatal death rates ranged from 41 per 1000 births in Pakistan to 8 per 1000 in Argentina. 54% of the neonatal deaths were >37 weeks and 46% weighed 2500 grams or more. Half the deaths occurred within 24 hours of delivery.
In our population-based low and middle income country registries, the majority of neonatal deaths occurred in babies >37 weeks gestation and almost half weighed at least 2500 grams. Most deaths occurred shortly after birth. With access to better medical care and hospitalization, especially in the intrapartum and early neonatal period, many of these neonatal deaths might be prevented.
PMCID: PMC4337792  PMID: 22644832
Neonatal mortality; low-income countries; preterm birth
23.  Association Between Stillbirth and Illicit Drug Use and Smoking During Pregnancy 
Obstetrics and gynecology  2014;123(1):113-125.
To compare illicit drug and smoking use in pregnancies with and without stillbirth.
The Stillbirth Collaborative Research Network conducted a case-control study from March 2006 to September 2008, covering more than 90% of deliveries to residents of five a priori defined geographically diverse regions. The study attempted to include all stillbirths and representative liveborn controls. Umbilical cord samples from cases and controls were collected and frozen for subsequent batch analysis. Maternal serum was collected at delivery and batch analyzed for cotinine.
For 663 stillbirth deliveries, 418 (63%) had cord homogenate and 579 (87%) had maternal cotinine assays performed. For 1,932 live birth deliveries, 1,050 (54%) had cord homogenate toxicology and 1,545 (80%) had maternal cotinine assays performed. A positive cord homogenate test for any illicit drug was associated with stillbirth (OR 1.94; 95% CI 1.16, 3.27). The most common individual drug was cannabis (OR 2.34; 95% CI 1.13, 4.81), although the effect was partially confounded by smoking. Both maternal self-reported smoking history and maternal serum cotinine levels were associated in a dose-response relationship with stillbirth. Positive serum cotinine < 3 ng/ml and no reported history of smoking (proxy for passive smoke exposure) also was associated with stillbirth (OR 2.06; 95% CI 1.24, 3.41).
Cannabis, smoking, illicit drug use, and apparent exposure to second-hand smoke, separately or in combination, during pregnancy were associated with an increased risk of stillbirth. As cannabis use may be increasing with increased legalization, the relevance of these findings may increase as well.
PMCID: PMC3931517  PMID: 24463671
24.  A multi-country study of the “intrapartum stillbirth and early neonatal death indicator” in hospitals in low-resource settings 
To determine the feasibility of introducing a simple indicator of quality of obstetric and neonatal care and to determine the proportion of potentially avoidable perinatal deaths in hospitals in low-income countries.
Between September 1, 2011, and February 29, 2012, data were collected from women who had a term pregnancy and were admitted to the labor ward of 1 of 6 hospitals in 4 low-income countries. Fetal heart tones on admission were monitored, and demographic and birth data were recorded.
Data were obtained for 3555 women and 3593 neonates (including twins). The doptone was used on 97% of women admitted. The overall perinatal mortality rate was 34 deaths per 1000 deliveries. Of the perinatal deaths, 40%–45% occurred in the hospital and were potentially preventable by better hospital care.
The results demonstrated that it is possible to accurately determine fetal viability on admission via a doptone. Implementation of doptone use, coupled with a concise data record, might form the basis of a low-cost and sustainable program to monitor and evaluate efforts to improve quality of care and ultimately might to help to reduce the in-hospital component of perinatal mortality in low-income countries.
PMCID: PMC3893914  PMID: 23796259
Doptone; Fetal heart tones; Hospital-based perinatal mortality; Neonatal mortality; Perinatal mortality; Stillbirth
25.  A review of studies with chlorhexidine applied directly to the umbilical cord 
American journal of perinatology  2013;30(8):10.1055/s-0032-1329695.
Infection-related neonatal mortality due to omphalitis in developing country home births is an important public health problem. Three cluster randomized trials of 4% chlorhexidine applied to the umbilical cord stump from 1 to multiple times in the days following a home birth have evaluated this intervention compared to other types of cord care on the development of omphalitis and neonatal mortality. Each of the 3 studies showed significant reductions in either omphalitis, neonatal mortality, or both with the 4% chlorhexidine. However, the optimal dosing schedule remains uncertain. While further studies are needed to clarify this issue, from the 3 studies it is now clear that with a minimum of one application of 4% chlorhexidine to the umbilical cord stump following delivery, the incidence of omphalitis and neonatal mortality can be reduced, especially in preterm newborns. This intervention, which is safe, inexpensive and requires minimal training and skill, should strongly be considered for adoption wherever home births occur.
PMCID: PMC3875170  PMID: 23254380

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