Publications by authors named "Shivaprasad S Goudar"

115 Publications

Blood pressure thresholds in pregnancy for identifying maternal and infant risk: a secondary analysis of Community-Level Interventions for Pre-eclampsia (CLIP) trial data.

Lancet Glob Health 2021 Aug 5;9(8):e1119-e1128. Epub 2021 Jul 5.

Department of Obstetrics and Gynaecology and BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.

Background: Blood pressure measurement is a marker of antenatal care quality. In well resourced settings, lower blood pressure cutoffs for hypertension are associated with adverse pregnancy outcomes. We aimed to study the associations between blood pressure thresholds and adverse outcomes and the diagnostic test properties of these blood pressure cutoffs in low-resource settings.

Methods: We did a secondary analysis of data from 22 intervention clusters in the Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised trials (NCT01911494) in India (n=6), Mozambique (n=6), and Pakistan (n=10). We included pregnant women aged 15-49 years (12-49 years in Mozambique), identified in their community by trained community health workers, who had data on blood pressure measurements and outcomes. The trial was unmasked. Maximum blood pressure was categorised as: normal blood pressure (systolic blood pressure [sBP] <120 mm Hg and diastolic blood pressure [dBP] <80 mm Hg), elevated blood pressure (sBP 120-129 mm Hg and dBP <80 mm Hg), stage 1 hypertension (sBP 130-139 mm Hg or dBP 80-89 mm Hg, or both), non-severe stage 2 hypertension (sBP 140-159 mm Hg or dBP 90-109 mm Hg, or both), or severe stage 2 hypertension (sBP ≥160 mm Hg or dBP ≥110 mm Hg, or both). We classified women according to the maximum blood pressure category reached across all visits for the primary analyses. The primary outcome was a maternal, fetal, or neonatal mortality or morbidity composite. We estimated dose-response relationships between blood pressure category and adverse outcomes, as well as diagnostic test properties.

Findings: Between Nov 1, 2014, and Feb 28, 2017, 21 069 women (6067 in India, 4163 in Mozambique, and 10 839 in Pakistan) contributed 103 679 blood pressure measurements across the three CLIP trials. Only women with non-severe or severe stage 2 hypertension, as discrete diagnostic categories, experienced more adverse outcomes than women with normal blood pressure (risk ratios 1·29-5·88). Using blood pressure categories as diagnostic thresholds (women with blood pressure within the category or any higher category vs those with blood pressure in any lower category), dose-response relationships were observed between increasing thresholds and adverse outcomes, but likelihood ratios were informative only for severe stage 2 hypertension and maternal CNS events (likelihood ratio 6·36 [95% CI 3·65-11·07]) and perinatal death (5·07 [3·64-7·07]), particularly stillbirth (8·53 [5·63-12·92]).

Interpretation: In low-resource settings, neither elevated blood pressure nor stage 1 hypertension were associated with maternal, fetal, or neonatal mortality or morbidity adverse composite outcomes. Only the threshold for severe stage 2 hypertension met diagnostic test performance standards. Current diagnostic thresholds for hypertension in pregnancy should be retained.

Funding: University of British Columbia, the Bill & Melinda Gates Foundation.
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http://dx.doi.org/10.1016/S2214-109X(21)00219-9DOI Listing
August 2021

Maternal and Fetal Vascular Lesions of Malperfusion in the Placentas Associated with Fetal and Neonatal Death: Results of a Prospective Observational Study.

Am J Obstet Gynecol 2021 Jun 7. Epub 2021 Jun 7.

Columbia University, New York NY USA.

Background: Fetal death, one of the major adverse pregnancy outcomes, is especially common in low and middle-income countries. Placental lesions may play an important role in the etiology of fetal and possibly neonatal death. Prior research relating placental lesions to fetal death causation was often hindered by the lack of agreement on a placental classification scheme. The Amsterdam Consensus statement, published in 2016, focused attention on malperfusions in the maternal and fetal placental circulations.

Objectives: Our purpose was to investigate the relationships of placental maternal vascular (MVM) and fetal vascular malperfusion (FVM) to fetal and neonatal death with a focus on the most important maternal clinical conditions in the pathway to fetal and neonatal death; maternal hypertension, antepartum haemorrhage and decreased fetal growth.

Study Design: This was a prospective, observational cohort study conducted at two Asian sites. Data collected included clinical history, gross and histologic evaluation of the placenta, and a number of other investigations to determine cause of death. The placenta was evaluated at both sites using the Amsterdam Consensus framework. We estimated the risk of placental MVM and FVM among fetal and neonatal deaths.

Results: Between July 2018 and January 2020 in India and Pakistan, 814 women with a fetal death, 618 with a preterm live birth and subsequent neonatal death, and 201 term live births, all with a placenta available for study, provided consent. The prevalence of MVM was higher in placentas of fetal deaths (58.4%) and preterm neonatal deaths (31.1%) compared to the term live births (15.4%). Adjusting for site, MVM had a RR of 3.88 (95% CI 2.70-5.59) among fetal deaths vs. term live births and a RR of 2.07 (95% CI 1.41-3.02) for preterm neonatal deaths vs. term live births. Infarcts and distal villous hypoplasia were the most common histological components of MVM. FVM was found less frequently in the placentas of fetal deaths (19.0%) than was MVM (58.4%). However, there were higher frequencies of FVM in fetal death placentas (19.0%) than in placentas from neonatal deaths (8.3%) or in the term live birth placentas (5.0%). Adjusting for site, FVM had a RR of 4.09 (95% CI 2.15-7.75) among fetal deaths vs. term live births and RR 1.77 (95% CI 0.90-3.49) for preterm neonatal deaths vs. term live births. There was a higher incidence of MVM in cases of maternal hypertension (71.4%), SGA (69.9%) and antepartum hemorrhage (59.1%) compared to the incidence of MVM in fetal deaths with none of these conditions (43.3%). There were no significant differences in the occurrence of FVM among the four clinical categories.

Conclusion(s): Histological examination of the placenta, especially for malperfusion disorders, is crucial in elucidating pathways to fetal death and likely for neonatal death in preterm infants. Possibly more important is the potential to focus on placental MVM and FVM during pregnancy as a means to identify fetuses at risk and to reduce the risk of fetal death by early delivery. It is our additional hope that the increased risk of fetal and neonatal death in these pregnancies can be reduced by development of an intervention to reduce the likelihood of developing MVM and/or FVM in the first place.
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http://dx.doi.org/10.1016/j.ajog.2021.06.001DOI Listing
June 2021

Safety of daily low-dose aspirin use during pregnancy in low-income and middle-income countries.

AJOG Glob Rep 2021 Feb 27;1(1). Epub 2021 Jan 27.

Department of Obstetrics/Gynecology, Thomas Jefferson University, Philadelphia, PA (Drs Short and Derman); Department of Obstetrics and Gynecology, Christiana Care, Newark, DE (Dr Hoffman); KLE Academy of Higher Education and Research Jawaharlal Nehru Medical College, Belagavi, Karnataka, India (Drs Metgud, Kavi, and Goudar); Kinshasa School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of the Congo (Drs Okitawutshu and Tshefu); University of North Carolina at Chapel Hill, Chapel Hill, NC (Dr Bose); University Teaching Hospital, Lusaka, Zambia (Drs Mwenechanya and Chomba); Department of Obstetrics/Gynecology, University of Alabama at Birmingham, Birmingham, AL (Dr Carlo); Instituto de Nutrición de Centro América y Panamá, Guatemala City, Guatemala (Drs Figueroa and Garces); University of Colorado School of Medicine, Aurora, CO (Dr Krebs); Aga Khan University, Karachi, Pakistan (Drs Jessani and Saleem); Department of Obstetrics/Gynecology, Columbia University, New York, NY (Dr Goldenberg); Lata Medical Research Foundation, Nagpur, India (Drs Das and Patel); Department of Global Health, Boston University School of Public Health, Boston, MA (Dr Hibbert); Department of Child Health and Paediatrics, Moi University School of Medicine, Eldoret, Kenya (Ms Achieng, Mr Nyongesa, and Dr Esamai); Indiana University School of Medicine, Indianapolis, IN (Dr Bucher); Research Triangle Institute International, Research Triangle Park, NC (Ms Nowak); Social, Statistical and Environmental Health Sciences, Research Triangle Institute International, Research Triangle Park, NC (Mr Goco, and Drs Nolen and McClure); Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (Drs Koso-Thomas and Miodovnik).

Background: The daily use of low-dose aspirin may be a safe, widely available, and inexpensive intervention for reducing the risk of preterm birth. Data on the potential side effects of low-dose aspirin use during pregnancy in low- and middle-income countries are needed.

Objective: This study aimed to assess differences in unexpected emergency medical visits and potential maternal side effects from a randomized, double-blind, multicountry, placebo-controlled trial of low-dose aspirin use (81 mg daily, from 6 to 36 weeks' gestation).

Study Design: This study was a secondary analysis of data from the Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas trial, a trial of the Global Network for Women's and Children's Health conducted in India (2 sites), Pakistan, Guatemala, Democratic Republic of the Congo, Kenya, and Zambia. The outcomes for this analysis were unexpected emergency medical visits and the occurrence of the following potential side effects-overall and separately-nausea, vomiting, rash or hives, diarrhea, gastritis, vaginal bleeding, allergic reaction, and any other potential side effects. Analyses were performed overall and by geographic region.

Results: Between the aspirin (n=5943) and placebo (n=5936) study groups, there was no statistically significant difference in the risk of unexpected emergency medical visits or the risk of any potential side effect (overall). Of the 8 potential side effects assessed, only 1 (rash or hives) presented a different risk by treatment group (4.2% in the aspirin group vs 3.5% in the placebo group; relative risk, 1.20; 95% confidence interval, 1.01-1.43; =.042).

Conclusion: The daily use of low-dose aspirin seems to be a safe intervention for reducing the risk of preterm birth and well tolerated by nulliparous pregnant women between 6 and 36 weeks' gestation in low- and middle-income countries.
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http://dx.doi.org/10.1016/j.xagr.2021.100003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8171270PMC
February 2021

Improved first trimester maternal iodine status with preconception supplementation: The Women First Trial.

Matern Child Nutr 2021 May 25:e13204. Epub 2021 May 25.

Department of Pediatrics, Section of Nutrition, University of Colorado School of Medicine, Aurora, Colorado, USA.

Maternal iodine (I) status is critical in embryonic and foetal development. We examined the effect of preconception iodine supplementation on maternal iodine status and on birth outcomes. Non-pregnant women in Guatemala, India and Pakistan (n ~ 100 per arm per site) were randomized ≥ 3 months prior to conception to one of three intervention arms: a multimicronutrient-fortified lipid-based nutrient supplement containing 250-μg I per day started immediately after randomization (Arm 1), the same supplement started at ~12 weeks gestation (Arm 2) and no intervention supplement (Arm 3). Urinary I (μg/L) to creatinine (mg/dl) ratios (I/Cr) were determined at 12 weeks for Arm 1 versus Arm 2 (before supplement started) and 34 weeks for all arms. Generalized linear models were used to assess the relationship of I/Cr with arm and with newborn anthropometry. At 12 weeks gestation, adjusted mean I/Cr (μg/g) for all sites combined was significantly higher for Arm 1 versus Arm 2: (203 [95% CI: 189, 217] vs. 163 [95% CI: 152, 175], p < 0.0001). Overall adjusted prevalence of I/Cr < 150 μg/g was also lower in Arm 1 versus Arm 2: 32% (95% CI: 26%, 38%) versus 43% (95% CI: 37%, 49%) (p = 0.0052). At 34 weeks, adjusted mean I/Cr for Arm 1 (235, 95% CI: 220, 252) and Arm 2 (254, 95% CI: 238, 272) did not differ significantly but were significantly higher than Arm 3 (200, 95% CI: 184, 218) (p < 0.0001). Nominally significant positive associations were observed between I/Cr at 12 weeks and birth length and head circumference z-scores (p = 0.028 and p = 0.005, respectively). These findings support the importance of first trimester iodine status and suggest need for preconception supplementation beyond salt iodization alone.
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http://dx.doi.org/10.1111/mcn.13204DOI Listing
May 2021

Economic and cost-effectiveness analysis of the Community-Level Interventions for Pre-eclampsia (CLIP) trials in India, Pakistan and Mozambique.

BMJ Glob Health 2021 05;6(5)

Department of Obstetrics and Gynaecology, The University of British Columbia, Vancouver, British Columbia, Canada

Background: The Community-Level Interventions for Pre-eclampsia (CLIP) trials (NCT01911494) in India, Pakistan and Mozambique (February 2014-2017) involved community engagement and task sharing with community health workers for triage and initial treatment of pregnancy hypertension. Maternal and perinatal mortality was less frequent among women who received ≥8 CLIP contacts. The aim of this analysis was to assess the incremental costs and cost-effectiveness of the CLIP intervention overall in comparison to standard of care, and by PIERS (Pre-eclampsia Integrated Estimate of RiSk) On the Move (POM) mobile health application visit frequency.

Methods: Included were all women enrolled in the three CLIP trials who had delivered with known outcomes by trial end. According to the number of POM-guided home contacts received (0, 1-3, 4-7, ≥8), costs were collected from annual budgets and spending receipts, with inclusion of family opportunity costs in Pakistan. A decision tree model was built to determine the cost-effectiveness of the intervention (vs usual care), based on the primary clinical endpoint of years of life lost (YLL) for mothers and infants. A probabilistic sensitivity analysis was used to assess uncertainty in the cost and clinical outcomes.

Results: The incremental per pregnancy cost of the intervention was US$12.66 (India), US$11.51 (Pakistan) and US$13.26 (Mozambique). As implemented, the intervention was not cost-effective due largely to minimal differences in YLL between arms. However, among women who received ≥8 CLIP contacts (four in Pakistan), the probability of health system and family (Pakistan) cost-effectiveness was ≥80% (all countries).

Conclusion: The intervention was likely to be cost-effective for women receiving ≥8 contacts in Mozambique and India, and ≥4 in Pakistan, supporting WHO guidance on antenatal contact frequency.

Trial Registration Number: NCT01911494.
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http://dx.doi.org/10.1136/bmjgh-2020-004123DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8149358PMC
May 2021

The impact of low-dose aspirin on markers of inflammation and placental function: an ancillary study of the ASPIRIN trial.

J Matern Fetal Neonatal Med 2021 May 20:1-5. Epub 2021 May 20.

Department of Physiology, J N Medical College, KLE Academy of Higher Education and Research, Belagavi, India.

Objective: To determine the impact of low-dose aspirin (81 mg) on markers of maternal inflammation and placental function.

Setting: Rural Southern India.

Population: Nulliparous women with a singleton pregnancy dated by ultrasound who were enrolled in the ASPIRIN (Aspirin Supplementation for Pregnancy Indicated risk Reduction In Nulliparas) Trial.

Methods: We performed a case-control study to elucidate the impact of low dose aspirin (LDA) on markers of placental function and maternal inflammation among women who delivered prematurely compared to term controls in women enrolled in the ASPIRIN trial. Women were prospectively enrolled in an ancillary observational trial wherein maternal serum was collected and measured between 10 to 13 weeks and 17 to 21 weeks of gestation after initiation of aspirin or an identical placebo.

Results: From 2016-18 with a total of 666 n women enrolled in this ancillary trial of whom 269 were selected for analyte analysis. Women who received LDA had lower levels of Alpha Feto-Protein (AFP) at 10 to 13 weeks than women who received placebo (Placebo) (LDA 18.3 ng/mL vs 21.4 ng/mL -P 0.001). AFP was similar between the two groups at 17 to 21 weeks. No other differences were seen in C-Reactive protein or Anti-Mullerian Hormone.

Conclusion: Low-dose aspirin administration lowers AFP early in pregnancy.
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http://dx.doi.org/10.1080/14767058.2021.1929160DOI Listing
May 2021

Pregnancy Outcomes and Blood Pressure Visit-to-Visit Variability and Level in Three Less-Developed Countries.

Hypertension 2021 May 29;77(5):1714-1722. Epub 2021 Mar 29.

Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine (L.A.M., H.L.N., A.H.S., P.v.D.), King's College London, United Kingdom.

[Figure: see text].
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http://dx.doi.org/10.1161/HYPERTENSIONAHA.120.16851DOI Listing
May 2021

Feasibility, acceptability, and preliminary impact of an mHealth supported breastfeeding peer counselor intervention in rural India.

Int J Gynaecol Obstet 2021 Jan 17. Epub 2021 Jan 17.

Thomas Jefferson University, Philadelphia, PA, USA.

Objective: To evaluate the feasibility of an mHealth-supported breastfeeding peer counselor intervention implemented in rural India and the preliminary impact of the intervention on maternal breastfeeding behaviors, including exclusive breastfeeding (EBF).

Methods: In this quasi-experimental pilot study, participants received either the intervention plus usual care (n = 110) or usual care alone (n = 112). The intervention group received nine in-home visits during and after pregnancy from peer counselors who provided education about and support for EBF and other optimal infant feeding practices and were aided with an mHealth tool. The control group received routine prenatal and postnatal health education. Progress notes and surveys were used to assess feasibility. Logistic regression models were used for between-group comparisons of optimal infant feeding outcomes, including EBF for 6 months.

Results: The intervention was delivered as intended, maintained over the study period, and had high acceptability ratings. There were statistically significant differences in all outcomes between groups. The intervention group had a significantly higher likelihood of EBF at 6 months compared to the control group (adjusted odds ratio 3.57, 95% confidence interval 1.80-7.07).

Conclusion: Integration of mHealth with community-based peer counselors to educate women about EBF is feasible and acceptable in rural India and impacts maternal breastfeeding behaviors.
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http://dx.doi.org/10.1002/ijgo.13599DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8285457PMC
January 2021

Regional trends in birth weight in low- and middle-income countries 2013-2018.

Reprod Health 2020 Dec 17;17(Suppl 3):176. Epub 2020 Dec 17.

Moi University School of Medicine, Eldoret, Kenya.

Background: Birth weight (BW) is a strong predictor of neonatal outcomes. The purpose of this study was to compare BWs between global regions (south Asia, sub-Saharan Africa, Central America) prospectively and to determine if trends exist in BW over time using the population-based maternal and newborn registry (MNHR) of the Global Network for Women'sand Children's Health Research (Global Network).

Methods: The MNHR is a prospective observational population-based registryof six research sites participating in the Global Network (2013-2018), within five low- and middle-income countries (Kenya, Zambia, India, Pakistan, and Guatemala) in threeglobal regions (sub-Saharan Af rica, south Asia, Central America). The birth weights were obtained for all infants born during the study period. This was done either by abstracting from the infants' health facility records or from direct measurement by the registry staff for infants born at home. After controlling for demographic characteristics, mixed-effect regression models were utilized to examine regional differences in birth weights over time.

Results: The overall BW meanswere higher for the African sites (Zambia and Kenya), 3186 g (SD 463 g) in 2013 and 3149 g (SD 449 g) in 2018, ascompared to Asian sites (Belagavi and Nagpur, India and Pakistan), 2717 g (SD450 g) in 2013 and 2713 g (SD 452 g) in 2018. The Central American site (Guatemala) had a mean BW intermediate between the African and south Asian sites, 2928 g (SD 452) in 2013, and 2874 g (SD 448) in 2018. The low birth weight (LBW) incidence was highest in the south Asian sites (India and Pakistan) and lowest in the African sites (Kenya and Zambia). The size of regional differences varied somewhat over time with slight decreases in the gap in birth weights between the African and Asian sites and slight increases in the gap between the African and Central American sites.

Conclusions: Overall, BWmeans by global region did not change significantly over the 5-year study period. From 2013 to 2018, infants enrolled at the African sites demonstrated the highest BW means overall across the entire study period, particularly as compared to Asian sites. The incidence of LBW was highest in the Asian sites (India and Pakistan) compared to the African and Central American sites. Trial registration The study is registered at clinicaltrials.gov. ClinicalTrial.gov Trial Registration: NCT01073475.
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http://dx.doi.org/10.1186/s12978-020-01026-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7745347PMC
December 2020

Association of parity with birthweight and neonatal death in five sites: The Global Network's Maternal Newborn Health Registry study.

Reprod Health 2020 Dec 17;17(Suppl 3):182. Epub 2020 Dec 17.

University of Colorado School of Medicine, Denver, CO, USA.

Background: Nulliparity has been associated with lower birth weight (BW) and other adverse pregnancy outcomes, with most of the data coming from high-income countries. In this study, we examined birth weight for gestational age z-scores and neonatal (28-day) mortality in a large prospective cohort of women dated by first trimester ultrasound from multiple sites in low and middle-income countries.

Methods: Pregnant women were recruited during the first trimester of pregnancy and followed through 6 weeks postpartum from Maternal Newborn Health Registry (MNHR) sites in the Democratic Republic of Congo (DRC), Guatemala, Belagavi and Nagpur, India, and Pakistan from 2017 and 2018. Data related to the pregnancy and its outcomes were collected prospectively. First trimester ultrasound was used for determination of gestational age; (BW) was obtained in grams within 48 h of delivery and later transformed to weight for age z-scores (WAZ) adjusted for gestational age using the INTERGROWTH-21st standards.

Results: 15,121 women were eligible and included. Infants of nulliparous women had lower mean BWs (males: 2676 gr, females: 2587 gr, total: 2634 gr) and gestational age adjusted weight for age z-scores (males: - 0.73, females: - 0.77, total: - 0.75,) than women with one or more previous pregnancies. The largest differences were between zero and one previous pregnancies among female infants. The associations of parity with BW and z-scores remained even after adjustment for maternal age, maternal height, maternal education, antenatal care visits, hypertensive disorders, and socioeconomic status. Nulliparous women also had a significantly higher < 28-day neonatal mortality rate (27.7 per 1,000 live births) than parous women (17.2 and 20.7 for parity of 1-3 and ≥ 4 respectively). Risk of preterm birth was higher among women with ≥ 4 previous pregnancies (15.5%) compared to 11.3% for the nulliparous group and 11.8% for women with one to three previous pregnancies (p = 0.0072).

Conclusions: In this large sample from diverse settings, nulliparity was independently associated with both lower BW and WAZ scores as well as higher neonatal mortality compared to multiparity.
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http://dx.doi.org/10.1186/s12978-020-01025-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7745358PMC
December 2020

Development of the Global Network for Women's and Children's Health Research's socioeconomic status index for use in the network's sites in low and lower middle-income countries.

Reprod Health 2020 Dec 17;17(Suppl 3):193. Epub 2020 Dec 17.

Department of Global Health, Boston University School of Public Health, Boston, MA, USA.

Background: Socioeconomic status (SES) is an important determinant of health globally and an important explanatory variable to assess causality in epidemiological research. The 10th Sustainable Development Goal is to reduce disparities in SES that impact health outcomes globally. It is easier to study SES in high-income countries because household income is representative of the SES. However, it is well recognized that income is poorly reported in low- and middle- income countries (LMIC) and is an unreliable indicator of SES. Therefore, there is a need for a robust index that will help to discriminate the SES of rural households in a pooled dataset from LMIC.

Methods: The study was nested in the population-based Maternal and Neonatal Health Registry of the Global Network for Women's and Children's Health Research which has 7 rural sites in 6 Asian, sub-Saharan African and Central American countries. Pregnant women enrolling in the Registry were asked questions about items such as housing conditions and household assets. The characteristics of the candidate items were evaluated using confirmatory factor analyses and item response theory analyses. Based on the results of these analyses, a final set of items were selected for the SES index.

Results: Using data from 49,536 households of pregnant women, we reduced the data collected to a 10-item index. The 10 items were feasible to administer, covered the SES continuum and had good internal reliability and validity. We developed a sum score-based Item Response Theory scoring algorithm which is easy to compute and is highly correlated with scores based on response patterns (r = 0.97), suggesting minimal loss of information with the simplified approach. Scores varied significantly by site (p < 0.001). African sites had lower mean SES scores than the Asian and Central American sites. The SES index demonstrated good internal consistency reliability (Cronbach's alpha = 0.81). Higher SES scores were significantly associated with formal education, more education, having received antenatal care, and facility delivery (p < 0.001).

Conclusions: While measuring SES in LMIC is challenging, we have developed a Global Network Socioeconomic Status Index which may be useful for comparisons of SES within and between locations. Next steps include understanding how the index is associated with maternal, perinatal and neonatal mortality. Trial Registration NCT01073475 Socioeconomic status (SES) is an important determinant of health globally, and improving SES is important to reduce disparities in health outcomes. It is easier to study SES in high-income countries because it can be measured by income and what income is spent on, but this concept does not translate easily to low and middle income countries. We developed a questionnaire that includes 10 items to determine SES in low-resource settings that was added to an ongoing Maternal and Neonatal Health Registry that is funded by the National Institutes of Child Health and Human Development's Global Network. The Registry includes sites that collect outcomes of pregnancies in women and their babies in rural areas in 6 countries in South Asia, sub-Saharan Africa and Central America. The Registry is population based and tracks women from early in pregnancy to day 42 post-partum. The questionnaire is easy to administer and has good reliability and validity. Next steps include understanding how the index is associated with maternal, fetal and neonatal mortality.
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http://dx.doi.org/10.1186/s12978-020-01034-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7745356PMC
December 2020

Gender variations in neonatal and early infant mortality in India and Pakistan: a secondary analysis from the Global Network Maternal Newborn Health Registry.

Reprod Health 2020 Dec 17;17(Suppl 3):178. Epub 2020 Dec 17.

Thomas Jefferson University, Philadelphia, PA, USA.

Background: To determine the gender differences in neonatal mortality, stillbirths, and perinatal mortality in south Asia using the Global Network data from the Maternal Newborn Health Registry.

Methods: This study is a secondary analysis of prospectively collected data from the three south Asian sites of the Global Network. The maternal and neonatal demographic, clinical characteristics, rates of stillbirths, early neonatal mortality (1-7 days), late neonatal mortality (8-28 days), mortality between 29-42 days and the number of infants hospitalized after birth were compared between the male and female infants.

Results: Between 2010 and 2018, 297,509 births [154,790 males (52.03%) and 142,719 females (47.97%)] from two Indian sites and one Pakistani site were included in the analysis [288,859 live births (97.1%) and 8,648 stillbirths (2.9%)]. The neonatal mortality rate was significantly higher in male infants (33.2/1,000 live births) compared to their female counterparts (27.4/1,000, p < 0.001). The rates of stillbirths (31.0 vs. 26.9/1000 births) and early neonatal mortality (27.1 vs 21.6/1000 live births) were also higher in males. However, there were no significant differences in late neonatal mortality (6.3 vs. 5.9/1000 live births) and mortality between 29-42 days (2.1 vs. 1.9/1000 live births) between the two groups. More male infants were hospitalized within 42 days after birth (1.8/1000 vs. 1.3/1000 live births, p < 0.001) than females.

Conclusion: The risks of stillbirths, and early neonatal mortality were higher among male infants than their female counterparts. However, there was no gender difference in mortality after 7 days of age. Our results highlight the importance of stratifying neonatal mortality into early and late neonatal period to better understand the impact of gender on neonatal mortality. The information from this study will help in developing strategies and identifying measures that can reduce differences in sex-specific mortality.
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http://dx.doi.org/10.1186/s12978-020-01028-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7745348PMC
December 2020

Rates and risk factors for preterm birth and low birthweight in the global network sites in six low- and low middle-income countries.

Reprod Health 2020 Dec 17;17(Suppl 3):187. Epub 2020 Dec 17.

School of Public Health, Boston University, Boston, MA, USA.

Background: Preterm birth continues to be a major public health problem contributing to 75% of the neonatal mortality worldwide. Low birth weight (LBW) is an important but imperfect surrogate for prematurity when accurate assessment of gestational age is not possible. While there is overlap between preterm birth and LBW newborns, those that are both premature and LBW are at the highest risk of adverse neonatal outcomes. Understanding the epidemiology of preterm birth and LBW is important for prevention and improved care for at risk newborns, but in many countries, data are sparse and incomplete.

Methods: We conducted data analyses using the Global Network's (GN) population-based registry of pregnant women and their babies in rural communities in six low- and middle-income countries (Democratic Republic of Congo, Kenya, Zambia, Guatemala, India and Pakistan). We analyzed data from January 2014 to December 2018. Trained study staff enrolled all pregnant women in the study catchment area as early as possible during pregnancy and conducted follow-up visits shortly after delivery and at 42 days after delivery. We analyzed the rates of preterm birth, LBW and the combination of preterm birth and LBW and studied risk factors associated with these outcomes across the GN sites.

Results: A total of 272,192 live births were included in the analysis. The overall preterm birth rate was 12.6% (ranging from 8.6% in Belagavi, India to 21.8% in the Pakistani site). The overall LBW rate was 13.6% (ranging from 2.7% in the Kenyan site to 21.4% in the Pakistani site). The overall rate of both preterm birth and LBW was 5.5% (ranging from 1.2% in the Kenyan site to 11.0% in the Pakistani site). Risk factors associated with preterm birth, LBW and the combination were similar across sites and included nulliparity [RR - 1.27 (95% CI 1.21-1.33)], maternal age under 20 [RR 1.41 (95% CI 1.32-1.49)] years, severe antenatal hemorrhage [RR 5.18 95% CI 4.44-6.04)], hypertensive disorders [RR 2.74 (95% CI - 1.21-1.33], and 1-3 antenatal visits versus four or more [RR 1.68 (95% CI 1.55-1.83)].

Conclusions: Preterm birth, LBW and their combination continue to be common public health problems at some of the GN sites, particularly among young, nulliparous women who have received limited antenatal care services. Trial registration The identifier of the Maternal and Newborn Health Registry at ClinicalTrials.gov is NCT01073475.

Trial Registration: The identifier of the Maternal and Newborn Health Registry at ClinicalTrials.gov is NCT01073475.
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http://dx.doi.org/10.1186/s12978-020-01029-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7745351PMC
December 2020

Cesarean birth in the Global Network for Women's and Children's Health Research: trends in utilization, risk factors, and subgroups with high cesarean birth rates.

Reprod Health 2020 Dec 17;17(Suppl 3):165. Epub 2020 Dec 17.

Department of Obstetrics and Gynecology, Columbia University School of Medicine, New York, NY, USA.

Background: The objectives of this analysis were to document trends in and risk factors associated with the cesarean birth rate in low- and middle-income country sites participating in the Global Network for Women's and Children's Health Research (Global Network).

Methods: This is a secondary analysis of a prospective, population-based study of home and facility births conducted in the Global Network sites.

Results: Cesarean birth rates increased uniformly across all sites between 2010 and 2018. Across all sites in multivariable analyses, women younger than age twenty had a reduced risk of cesarean birth (RR 0.9 [0.9, 0.9]) and women over 35 had an increased risk of cesarean birth (RR 1.1 [1.1, 1.1]) compared to women aged 20 to 35. Compared to women with a parity of three or more, less parous women had an increased risk of cesarean (RR 1.2 or greater [1.2, 1.4]). Four or more antenatal visits (RR 1.2 [1.2, 1.3]), multiple pregnancy (RR 1.3 [1.3, 1.4]), abnormal progress in labor (RR 1.1 [1.0, 1.1]), antepartum hemorrhage (RR 2.3 [2.0, 2.7]), and hypertensive disease (RR 1.6 [1.5, 1.7]) were all associated with an increased risk of cesarean birth, p < 0.001. For multiparous women with a history of prior cesarean birth, rates of vaginal birth after cesarean were about 20% in the Latin American and Southeast Asian sites and about 84% at the sub-Saharan African sites. In the African sites, proportions of cesarean birth in the study were highest among women without a prior cesarean and a single, cephalic, term pregnancy. In the non-African sites, groups with the greatest proportion of cesarean births were nulliparous women with a single, cephalic, term pregnancy and all multiparous women with at least one previous uterine scar with a term, cephalic pregnancy.

Conclusion: Cesarean birth rates continue to rise within the Global Network. The proportions of cesarean birth are higher among women with no history of cesarean birth in the African sites and among women with primary elective cesarean, primary cesarean after induction, and repeat cesarean in the non-African sites.
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http://dx.doi.org/10.1186/s12978-020-01021-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7745346PMC
December 2020

Maternal mortality in six low and lower-middle income countries from 2010 to 2018: risk factors and trends.

Reprod Health 2020 Dec 17;17(Suppl 3):173. Epub 2020 Dec 17.

Department of Pediatrics, University of North Carolina School of Medicine, 101 Manning Drive, CB 7596, Chapel Hill, NC, 27599-7596, USA.

Background: Maternal mortality is a public health problem that disproportionately affects low and lower-middle income countries (LMICs). Appropriate data sources are lacking to effectively track maternal mortality and monitor changes in this health indicator over time.

Methods: We analyzed data from women enrolled in the NICHD Global Network for Women's and Children's Health Research Maternal Newborn Health Registry (MNHR) from 2010 through 2018. Women delivering within research sites in the Democratic Republic of Congo, Guatemala, India (Nagpur and Belagavi), Kenya, Pakistan, and Zambia are included. We evaluated maternal and delivery characteristics using log-binomial models and multivariable models to obtain relative risk estimates for mortality. We used running averages to track maternal mortality ratio (MMR, maternal deaths per 100,000 live births) over time.

Results: We evaluated 571,321 pregnancies and 842 maternal deaths. We observed an MMR of 157 / 100,000 live births (95% CI 147, 167) across all sites, with a range of MMRs from 97 (76, 118) in the Guatemala site to 327 (293, 361) in the Pakistan site. When adjusted for maternal risk factors, risks of maternal mortality were higher with maternal age > 35 (RR 1.43 (1.06, 1.92)), no maternal education (RR 3.40 (2.08, 5.55)), lower education (RR 2.46 (1.54, 3.94)), nulliparity (RR 1.24 (1.01, 1.52)) and parity > 2 (RR 1.48 (1.15, 1.89)). Increased risk of maternal mortality was also associated with occurrence of obstructed labor (RR 1.58 (1.14, 2.19)), severe antepartum hemorrhage (RR 2.59 (1.83, 3.66)) and hypertensive disorders (RR 6.87 (5.05, 9.34)). Before and after adjusting for other characteristics, physician attendance at delivery, delivery in hospital and Caesarean delivery were associated with increased risk. We observed variable changes over time in the MMR within sites.

Conclusions: The MNHR is a useful tool for tracking MMRs in these LMICs. We identified maternal and delivery characteristics associated with increased risk of death, some might be confounded by indication. Despite declines in MMR in some sites, all sites had an MMR higher than the Sustainable Development Goals target of below 70 per 100,000 live births by 2030.

Trial Registration: The MNHR is registered at NCT01073475 .
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http://dx.doi.org/10.1186/s12978-020-00990-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7745363PMC
December 2020

Institutional deliveries and stillbirth and neonatal mortality in the Global Network's Maternal and Newborn Health Registry.

Reprod Health 2020 Dec 17;17(Suppl 3):179. Epub 2020 Dec 17.

Thomas Jefferson University, Philadelphia, PA, USA.

Background: Few studies have shown how the move toward institutional delivery in low and middle-income countries (LMIC) impacts stillbirth and newborn mortality.

Objectives: The study evaluated trends in institutional delivery in research sites in Belagavi and Nagpur India, Guatemala, Kenya, Pakistan, and Zambia from 2010 to 2018 and compared them to changes in the rates of neonatal mortality and stillbirth.

Methods: We analyzed data from a nine-year interval captured in the Global Network (GN) Maternal Newborn Health Registry (MNHR). Mortality rates were estimated from generalized estimating equations controlling for within-cluster correlation. Cluster-level analyses were performed to assess the association between institutional delivery and mortality rates.

Results: From 2010 to 2018, a total of 413,377 deliveries in 80 clusters across 6 sites in 5 countries were included in these analyses. An increase in the proportion of institutional deliveries occurred in all sites, with a range in 2018 from 57.7 to 99.8%. In 2010, the stillbirth rates ranged from 19.3 per 1000 births in the Kenyan site to 46.2 per 1000 births in the Pakistani site and by 2018, ranged from 9.7 per 1000 births in the Belagavi, India site to 40.8 per 1000 births in the Pakistani site. The 2010 neonatal mortality rates ranged from 19.0 per 1000 live births in the Kenyan site to 51.3 per 1000 live births in the Pakistani site with the 2018 neonatal mortality rates ranging from 9.2 per 1000 live births in the Zambian site to 50.2 per 1000 live births in the Pakistani site. In multivariate modeling, in some but not all sites, the reductions in stillbirth and neonatal death were significantly associated with an increase in the institutional deliveries.

Conclusions: There was an increase in institutional delivery rates in all sites and a reduction in stillbirth and neonatal mortality rates in some of the GN sites over the past decade. The relationship between institutional delivery and a decrease in mortality was significant in some but not all sites. However, the stillbirth and neonatal mortality rates remain at high levels. Understanding the relationship between institutional delivery and stillbirth and neonatal deaths in resource-limited environments will enable development of targeted interventions for reducing the mortality burden.

Trial Registration: The study is registered at clinicaltrials.gov . ClinicalTrial.gov Trial Registration: NCT01073475 .
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http://dx.doi.org/10.1186/s12978-020-01001-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7745350PMC
December 2020

Why are the Pakistani maternal, fetal and newborn outcomes so poor compared to other low and middle-income countries?

Reprod Health 2020 Dec 17;17(Suppl 3):190. Epub 2020 Dec 17.

Department of Obstetrics and Gynecology, Columbia University School of Medicine, New York, NY, USA.

Background: Pakistan has among the poorest pregnancy outcomes worldwide, significantly worse than many other low-resource countries. The reasons for these differences are not clear. In this study, we compared pregnancy outcomes in Pakistan to other low-resource countries and explored factors that might help explain these differences.

Methods: The Global Network (GN) Maternal Newborn Health Registry (MNHR) is a prospective, population-based observational study that includes all pregnant women and their pregnancy outcomes in defined geographic communities in six low-middle income countries (India, Pakistan, Democratic Republic of Congo, Guatemala, Kenya, Zambia). Study staff enroll women in early pregnancy and follow-up soon after delivery and at 42 days to ascertain delivery, neonatal, and maternal outcomes. We analyzed the maternal mortality ratios (MMR), neonatal mortality rates (NMR), stillbirth rates, and potential explanatory factors from 2010 to 2018 across the GN sites.

Results: From 2010 to 2018, there were 91,076 births in Pakistan and 456,276 births in the other GN sites combined. The MMR in Pakistan was 319 per 100,000 live births compared to an average of 124 in the other sites, while the Pakistan NMR was 49.4 per 1,000 live births compared to 20.4 in the other sites. The stillbirth rate in Pakistan was 53.5 per 1000 births compared to 23.2 for the other sites. Preterm birth and low birthweight rates were also substantially higher than the other sites combined. Within weight ranges, the Pakistani site generally had significantly higher rates of stillbirth and neonatal mortality than the other sites combined, with differences increasing as birthweights increased. By nearly every measure, medical care for pregnant women and their newborns in the Pakistan sites was worse than at the other sites combined.

Conclusion: The Pakistani pregnancy outcomes are much worse than those in the other GN sites. Reasons for these poorer outcomes likely include that the Pakistani sites' reproductive-aged women are largely poorly educated, undernourished, anemic, and deliver a high percentage of preterm and low-birthweight babies in settings of often inadequate maternal and newborn care. By addressing the issues highlighted in this paper there appears to be substantial room for improvements in Pakistan's pregnancy outcomes.
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http://dx.doi.org/10.1186/s12978-020-01023-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7745345PMC
December 2020

Evaluating the effect of care around labor and delivery practices on early neonatal mortality in the Global Network's Maternal and Newborn Health Registry.

Reprod Health 2020 Nov 30;17(Suppl 2):156. Epub 2020 Nov 30.

School of Public Health, Boston University, Boston, MA, USA.

Background: Neonatal deaths in first 28-days of life represent 47% of all deaths under the age of five years globally and are a focus of the United Nation's (UN's) Sustainable Development Goals. Pregnant women are delivering in facilities but that does not indicate quality of care during delivery and the postpartum period. The World Health Organization's Essential Newborn Care (ENC) package reduces neonatal mortality, but lacks a simple and valid composite index that measures its effectiveness.

Methods: Data on 5 intra-partum and 3 post-partum practices (indicators) recommended as part of ENC, routinely collected in NICHD's Global Network's (GN) Maternal Newborn Health Registry (MNHR) between 2010 and 2013, were included. We evaluated if all 8 practices (Care around Delivery - CAD), combined as an index was associated with reduced early neonatal mortality rates (days 0-6 of life).

Results: A total of 150,848 live births were included in the analysis. The individual indicators varied across sites. All components were present in 19.9% births (range 0.4 to 31% across sites). Present indicators (8 components) were associated with reduced early neonatal mortality [adjusted RR (95% CI):0.81 (0.77, 0.85); p < 0.0001]. Despite an overall association between CAD and early neonatal mortality (RR < 1.0 for all early mortality): delivery by skilled birth attendant; presence of fetal heart and delayed bathing were associated with increased early neonatal mortality.

Conclusions: Present indicators (8 practices) of CAD were associated with a 19% reduction in the risk of neonatal death in the diverse health facilities where delivery occurred within the GN MNHR. These indicators could be monitored to identify facilities that need to improve compliance with ENC practices to reduce preventable neonatal deaths. Three of the 8 indicators were associated with increased neonatal mortality, due to baby being sick at birth. Although promising, this composite index needs refinement before use to monitor facility-based quality of care in association with early neonatal mortality. Trial registration The identifier of the Maternal Newborn Health Registry at ClinicalTrials.gov is NCT01073475.
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http://dx.doi.org/10.1186/s12978-020-01010-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7708898PMC
November 2020

The relationship between birth intervals and adverse maternal and neonatal outcomes in six low and lower-middle income countries.

Reprod Health 2020 Nov 30;17(Suppl 2):157. Epub 2020 Nov 30.

Department of Pediatrics, University of North Carolina at Chapel Hill, School of Medicine, 101 Manning Drive, Chapel Hill, NC, CB 7596, USA.

Background: Due to high fertility rates in some low and lower-middle income countries, the interval between pregnancies can be short, which may lead to adverse maternal and neonatal outcomes.

Methods: We analyzed data from women enrolled in the NICHD Global Network Maternal Newborn Health Registry (MNHR) from 2013 through 2018. We report maternal characteristics and outcomes in relationship to the inter-delivery interval (IDI, time from previous delivery [live or stillborn] to the delivery of the index birth), by category of 6-17 months (short), 18-36 months (reference), 37-60 months, and 61-180 months (long). We used non-parametric tests for maternal characteristics, and multivariable logistic regression models for outcomes, controlling for differences in baseline characteristics.

Results: We evaluated 181,782 women from sites in the Democratic Republic of Congo, Zambia, Kenya, Guatemala, India, and Pakistan. Women with short IDI varied by site, from 3% in the Zambia site to 20% in the Pakistan site. Relative to a 18-36 month IDI, women with short IDI had increased risk of neonatal death (RR = 1.89 [1.74, 2.05]), stillbirth (RR = 1.70 [1.56, 1.86]), low birth weight (RR = 1.38 [1.32, 1.44]), and very low birth weight (RR = 2.35 [2.10, 2.62]). Relative to a 18-36 month IDI, women with IDI of 37-60 months had an increased risk of maternal death (RR 1.40 [1.05, 1.88]), stillbirth (RR 1.14 [1.08, 1.22]), and very low birth weight (RR 1.10 [1.01, 1.21]). Relative to a 18-36 month IDI, women with long IDI had increased risk of maternal death (RR 1.54 [1.10, 2.16]), neonatal death (RR = 1.25 [1.14, 1.38]), stillbirth (RR = 1.50 [1.38, 1.62]), low birth weight (RR = 1.22 [1.17, 1.27]), and very low birth weight (RR = 1.47 [1.32,1.64]). Short and long IDIs were also associated with increased risk of obstructed labor, hemorrhage, hypertensive disorders, fetal malposition, infection, hospitalization, preterm delivery, and neonatal hospitalization.

Conclusions: IDI varies by site. When compared to 18-36 month IDI, women with both short IDI and long IDI had increased risk of adverse maternal and neonatal outcomes.

Trial Registration: The MNHR is registered at NCT01073475 .
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http://dx.doi.org/10.1186/s12978-020-01008-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7708104PMC
November 2020

Stillbirth 2010-2018: a prospective, population-based, multi-country study from the Global Network.

Reprod Health 2020 Nov 30;17(Suppl 2):146. Epub 2020 Nov 30.

Department of Obstetrics and Gynecology, Columbia University School of Medicine, New York, NY, USA.

Background: Stillbirth rates are high and represent a substantial proportion of the under-5 mortality in low and middle-income countries (LMIC). In LMIC, where nearly 98% of stillbirths worldwide occur, few population-based studies have documented cause of stillbirths or the trends in rate of stillbirth over time.

Methods: We undertook a prospective, population-based multi-country research study of all pregnant women in defined geographic areas across 7 sites in low-resource settings (Kenya, Zambia, Democratic Republic of Congo, India, Pakistan, and Guatemala). Staff collected demographic and health care characteristics with outcomes obtained at delivery. Cause of stillbirth was assigned by algorithm.

Results: From 2010 through 2018, 573,148 women were enrolled with delivery data obtained. Of the 552,547 births that reached 500 g or 20 weeks gestation, 15,604 were stillbirths; a rate of 28.2 stillbirths per 1000 births. The stillbirth rates were 19.3 in the Guatemala site, 23.8 in the African sites, and 33.3 in the Asian sites. Specifically, stillbirth rates were highest in the Pakistan site, which also documented a substantial decrease in stillbirth rates over the study period, from 56.0 per 1000 (95% CI 51.0, 61.0) in 2010 to 44.4 per 1000 (95% CI 39.1, 49.7) in 2018. The Nagpur, India site also documented a substantial decrease in stillbirths from 32.5 (95% CI 29.0, 36.1) to 16.9 (95% CI 13.9, 19.9) per 1000 in 2018; however, other sites had only small declines in stillbirth over the same period. Women who were less educated and older as well as those with less access to antenatal care and with vaginal assisted delivery were at increased risk of stillbirth. The major fetal causes of stillbirth were birth asphyxia (44.0% of stillbirths) and infectious causes (22.2%). The maternal conditions that were observed among those with stillbirth were obstructed or prolonged labor, antepartum hemorrhage and maternal infections.

Conclusions: Over the study period, stillbirth rates have remained relatively high across all sites. With the exceptions of the Pakistan and Nagpur sites, Global Network sites did not observe substantial changes in their stillbirth rates. Women who were less educated and had less access to antenatal and obstetric care remained at the highest burden of stillbirth.

Study Registration: Clinicaltrials.gov (ID# NCT01073475).
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http://dx.doi.org/10.1186/s12978-020-00991-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7706249PMC
November 2020

Neonatal deaths in infants born weighing ≥ 2500 g in low and middle-income countries.

Reprod Health 2020 Nov 30;17(Suppl 2):158. Epub 2020 Nov 30.

Department of Obstetrics and Gynecology, Columbia University School of Medicine, New York, NY, USA.

Background: Babies born weighing ≥ 2500 g account for more than 80% of the births in most resource-limited locations and for nearly 50% of the 28-day neonatal deaths. In contrast, in high-resource settings, 28-day neonatal mortality among this group represents only a small fraction of the neonatal deaths. Yet mortality risks for birth weight of ≥ 2500 g is limited. Knowledge regarding the factors associated with mortality in these babies will help in identifying interventions that can reduce mortality.

Methods: The Global Network's Maternal Newborn Health Registry (MNHR) is a prospective, population-based observational study that includes all pregnant women and their pregnancy outcomes in defined geographic communities that has been conducted in research sites in six low-middle income countries (India, Pakistan, Democratic Republic of Congo, Guatemala, Kenya and Zambia). Study staff enroll all pregnant women as early as possible during pregnancy and conduct follow-up visits to ascertain delivery and 28-day neonatal outcomes. We analyzed the neonatal mortality rates (NMR) and risk factors for deaths by 28 days among all live-born babies with a birthweight ≥ 2500 g from 2010 to 2018 across the Global Network sites.

Results: Babies born in the Global Network sites from 2010 to 2018 with a birthweight ≥ 2500 g accounted for 84.8% of the births and 45.4% of the 28-day neonatal deaths. Among this group, the overall NMR was 13.1/1000 live births. The overall 28-day NMR for ongoing clusters was highest in Pakistan (29.7/1000 live births) and lowest in the Zambian/Kenyan sites (9.3/1000) for ≥ 2500 g infants. ≥ 2500 g NMRs declined for Zambia/Kenya and India. For Pakistan and Guatemala, the NMR remained almost unchanged over the period. The ≥ 2500 g risks related to maternal, delivery and newborn characteristics varied by site. Maternal factors that increased risk and were common for all sites included nulliparity, hypertensive disease, previous stillbirth, maternal death, obstructed labor, severe postpartum hemorrhage, and abnormal fetal presentation. Neonatal characteristics including resuscitation, hospitalization, congenital anomalies and male sex, as well as lower gestational ages and birthweights were also associated with increased mortality.

Conclusions: Nearly half of neonatal deaths in the Global Network sites occurred in infants born weighing ≥ 2500 g. The NMR for those infants was 13.1 per 1000 live births, much higher than rates usually seen in high-income countries. The changes in NMR over time varied across the sites. Even among babies born ≥ 2500 g, lower gestational age and birthweight were largely associated with increased risk of mortality. Since many of these deaths should be preventable, attention to preventing mortality in these infants should have an important impact on overall NMR.

Trial Registration: https://ClinicalTrials.gov Identifier: NCT01073475.
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http://dx.doi.org/10.1186/s12978-020-01013-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7706246PMC
November 2020

Looking beyond the numbers: quality assurance procedures in the Global Network for Women's and Children's Health Research Maternal Newborn Health Registry.

Reprod Health 2020 Nov 30;17(Suppl 2):159. Epub 2020 Nov 30.

University of Colorado School of Medicine, Denver, CO, USA.

Background: Quality assurance (QA) is a process that should be an integral part of research to protect the rights and safety of study participants and to reduce the likelihood that the results are affected by bias in data collection. Most QA plans include processes related to study preparation and regulatory compliance, data collection, data analysis and publication of study results. However, little detailed information is available on the specific procedures associated with QA processes to ensure high-quality data in multi-site studies.

Methods: The Global Network for Women's and Children's Health Maternal Newborn Health Registy (MNHR) is a prospective population-based registry of pregnancies and deliveries that is carried out in 8 international sites. Since its inception, QA procedures have been utilized to ensure the quality of the data. More recently, a training and certification process was developed to ensure that standardized, scientifically accurate clinical definitions are used consistently across sites. Staff complete a web-based training module that reviews the MNHR study protocol, study forms and clinical definitions developed by MNHR investigators and are certified through a multiple choice examination prior to initiating study activities and every six months thereafter. A standardized procedure for supervision and evaluation of field staff is carried out to ensure that research activites are conducted according to the protocol across all the MNHR sites.

Conclusions: We developed standardized QA processes for training, certification and supervision of the MNHR, a multisite research registry. It is expected that these activities, together with ongoing QA processes, will help to further optimize data quality for this protocol.
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http://dx.doi.org/10.1186/s12978-020-01009-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7708152PMC
November 2020

Neonatal deaths in rural Karnataka, India 2014-2018: a prospective population-based observational study in a low-resource setting.

Reprod Health 2020 Nov 30;17(Suppl 2):161. Epub 2020 Nov 30.

Women's and Children's Health Research Unit JN Medical College, KLE Academy of Higher Education and Research Belagavi, Belagavi, Karnataka, India.

Background: Neonatal mortality causes a substantial proportion of the under-5 mortality in low and middle-income countries (LMIC).

Methods: We undertook a prospective, population-based research study of pregnant women residing in defined geographic areas in the Karnataka State of India, a research site of the Global Network for Women's and Children's Health Research. Study staff collected demographic and health care characteristics on eligible women enrolled with neonatal outcomes obtained at delivery and day 28. Cause of neonatal mortality at day 28 was assigned by algorithm using prospectively defined variables.

Results: From 2014 to 2018, the neonatal mortality rate was 24.5 per 1,000 live births. The cause of the 28-day neonatal deaths was attributed to prematurity (27.9%), birth asphyxia (25.1%), infection (23.7%) and congenital anomalies (18.4%). Four or more antenatal care (ANC) visits was associated with a lower risk of neonatal death compared to fewer ANC visits. In the adjusted model, compared to liveborn infants ≥ 2500 g, infants born weighing < 1000 g RR for mortality was 25.6 (95%CI 18.3, 36.0), for 1000-1499 g infants the RR was 19.8 (95% CI 14.2, 27.5) and for 1500-2499 g infants the RR was 3.1 (95% CI 2.7, 3.6). However, more than one-third (36.8%) of the deaths occurred among infants with a birthweight ≥ 2500 g. Infants born preterm (< 37 weeks) were also at higher risk for 28-day mortality (RR 7.9, 95% CI 6.9, 9.0) compared to infants ≥ 37 weeks. A one-week decrease in gestational age at delivery was associated with a higher risk of mortality with a RR of 1.3 (95% CI 1.3, 1.3). More than 70% of all the deliveries occurred at a hospital. Among infants who died, 50.3% of the infants had received bag/mask ventilation, 47.3% received antibiotics, and 55.6% received oxygen.

Conclusions: Consistent with prior research, the study found that infants who were preterm and low-birth weight remained at highest risk for 28-day neonatal mortality in India. Although most of births now occur within health facilities, a substantial proportion are not receiving basic life-saving interventions. Further efforts to understand the impact of care on infant outcomes are needed. Study registration The trial is registered at clinicaltrials.gov. ClinicalTrial.gov Trial Registration: NCT01073475.
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http://dx.doi.org/10.1186/s12978-020-01014-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7708103PMC
November 2020

Hemoglobin concentrations and adverse birth outcomes in South Asian pregnant women: findings from a prospective Maternal and Neonatal Health Registry.

Reprod Health 2020 Nov 30;17(Suppl 2):154. Epub 2020 Nov 30.

Department of Obstetrics and Gynecology, Columbia University, New York, NY, USA.

Background: While the relationship between hemoglobin (Hb) concentrations and pregnancy outcomes has been studied often, most reports have focused on a specific Hb cutoff used to define anemia. Fewer studies have evaluated pregnancy outcomes across the entire range of Hb values. Moreover, to date, most studies of the relationship of Hb concentrations to pregnancy outcomes have been done in high-income countries. Thus, we have sought to determine the relationship between the range of maternal Hb concentrations and adverse birth outcomes among South Asian pregnant women.

Methods: For this study, we used data collected from two South Asian countries (Pakistan - Sindh Province and two sites in India - Belagavi and Nagpur) in a prospective maternal and newborn health registry study. To assess the association between Hb concentrations and various maternal and fetal outcomes, we classified the Hb concentrations into seven categories. Regression analyses adjusting for multiple potential confounders were performed to assess adverse pregnancy outcomes across the range of Hb concentrations.

Findings: Between January 2012 and December 2018, 130,888 pregnant women were enrolled in the South Asian sites had a Hb measurement available, delivered and were included in the analyses. Overall, the mean Hb concentration of pregnant women from the sites was 9.9 g/dL, 10.0 g/dL in the Indian sites and 9.5 g/dL in the Pakistan site. Hb concentrations < 7 g/dL were observed in 6.9% of the pregnant Pakistani women and 0.2% of the Indian women. In both the Pakistani and Indian sites, women with higher parity and women with no formal education had lower Hb concentrations. In the Pakistani site, women > 35 years of age, women with ≥4 children and those who enrolled in the third trimester were more likely to have Hb concentrations of < 7 g/dL but these associations were not found for the Indian sites. When adjusting for potential confounders, for both India and Pakistan, lower Hb concentrations were associated with stillbirth, preterm birth, lower mean birthweight, and increased risk of low birthweight. In the Pakistani site, there was evidence of a U-shaped relationship between Hb concentrations and low birth weight, and neonatal mortality, and in India with hypertensive disease.

Interpretation: This study documented the relationship between maternal Hb concentrations and adverse pregnancy outcomes in women from the Pakistani and Indian sites across the range of Hb values. Both low and high Hb concentrations were associated with risk of at least some adverse outcomes. Hence, both low and high values of Hb should be considered risk factors for the mother and fetus.
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http://dx.doi.org/10.1186/s12978-020-01006-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7706196PMC
November 2020

The Global Network Maternal Newborn Health Registry: a multi-country, community-based registry of pregnancy outcomes.

Reprod Health 2020 Nov 30;17(Suppl 2):184. Epub 2020 Nov 30.

Department of Obstetrics and Gynecology, Columbia University School of Medicine, New York, NY, USA.

Background: The Global Network for Women's and Children's Health Research (Global Network) conducts clinical trials in resource-limited countries through partnerships among U.S. investigators, international investigators based in in low and middle-income countries (LMICs) and a central data coordinating center. The Global Network's objectives include evaluating low-cost, sustainable interventions to improve women's and children's health in LMICs. Accurate reporting of births, stillbirths, neonatal deaths, maternal mortality, and measures of obstetric and neonatal care is critical to determine strategies for improving pregnancy outcomes. In response to this need, the Global Network developed the Maternal Newborn Health Registry (MNHR), a prospective, population-based registry of pregnant women, fetuses and neonates receiving care in defined catchment areas at the Global Network sites. This publication describes the MNHR, including participating sites, data management and quality and changes over time.

Methods: Pregnant women who reside in or receive healthcare in select communities are enrolled in the MNHR of the Global Network. For each woman and her offspring, sociodemographic, health care, and the major outcomes through 42-days post-delivery are recorded. Study visits occur at enrollment during pregnancy, at delivery and at 42 days postpartum.

Results: From 2010 through 2018, the Global Network MNHR sites were located in Guatemala, Belagavi and Nagpur, India, Pakistan, Democratic Republic of Congo, Kenya, and Zambia. During this period at these sites, 579,140 pregnant women were consented and enrolled in the MNHR, nearly 99% of all eligible women. Delivery data were collected for 99% of enrolled women and 42-day follow-up data for 99% of those delivered. In this supplement, the trends over time and assessment of differences across geographic regions are analyzed in a series of 18 manuscripts utilizing the MNHR data.

Conclusions: Improving maternal, fetal and newborn health in countries with poor outcomes requires an understanding of the characteristics of the population, quality of health care and outcomes. 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. Trial Registration The Maternal Newborn Health Registry is registered at Clinicaltrials.gov (ID# NCT01073475). Registered February 23, 2019. https://clinicaltrials.gov/ct2/show/NCT01073475.
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http://dx.doi.org/10.1186/s12978-020-01020-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7708188PMC
November 2020

Maternal infection and stillbirth: a review.

J Matern Fetal Neonatal Med 2020 Nov 24:1-9. Epub 2020 Nov 24.

Department of Obstetrics and Gynecology, Columbia University, New York, NY, USA.

Maternal infections likely are an important cause of stillbirths, especially in sub-Saharan Africa and south Asia, where the burden is highest. Due to the lack of routine testing for infection, which can be complex and often expensive, the prevalence of infection during pregnancy and the association of many infections with stillbirth are not well-documented, especially in low-resource countries. Following an extensive literature review of infection and stillbirth initially published in 2010, we conducted a review of literature in the last 10 years to identify infections associated with stillbirth, focused on those in low-resource settings. During the last 10 years, over 40 bacterial, viral and other pathogens have been associated with stillbirth. Newly emerging viral infections such as Denge as well as several well-established, but not yet eliminated infections such as rubella have been associated with stillbirth. Two of the maternal infections most strongly associated with stillbirth, each with about a 2-fold risk, are malaria and syphilis but others have been associated with risk in a range of studies. With a lack of routine antenatal screening, many pathogens are identified as associated with stillbirth only through case reports. Infection remains an important, yet understudied, cause of stillbirth. Research studies to determine definitive associations between various infections and stillbirth are important to better understand the role of infections and strategies to reduce infection-related stillbirth. This review explores the association between infections and stillbirths focusing on low-income country studies published in the last 10 years. Much information about these relationships comes from case reports. Research resulting in a better understanding of the causes and strategies to reduce infection-related stillbirth is necessary.
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http://dx.doi.org/10.1080/14767058.2020.1852206DOI Listing
November 2020

Predictive Modeling for Perinatal Mortality in Resource-Limited Settings.

JAMA Netw Open 2020 11 2;3(11):e2026750. Epub 2020 Nov 2.

University of Alabama at Birmingham.

Importance: The overwhelming majority of fetal and neonatal deaths occur in low- and middle-income countries. Fetal and neonatal risk assessment tools may be useful to predict the risk of death.

Objective: To develop risk prediction models for intrapartum stillbirth and neonatal death.

Design, Setting, And Participants: This cohort study used data from the Eunice Kennedy Shriver National Institute of Child Health and Human Development Global Network for Women's and Children's Health Research population-based vital registry, including clinical sites in South Asia (India and Pakistan), Africa (Democratic Republic of Congo, Zambia, and Kenya), and Latin America (Guatemala). A total of 502 648 pregnancies were prospectively enrolled in the registry.

Exposures: Risk factors were added sequentially into the data set in 4 scenarios: (1) prenatal, (2) predelivery, (3) delivery and day 1, and (4) postdelivery through day 2.

Main Outcomes And Measures: Data sets were randomly divided into 10 groups of 3 analysis data sets including training (60%), test (20%), and validation (20%). Conventional and advanced machine learning modeling techniques were applied to assess predictive abilities using area under the curve (AUC) for intrapartum stillbirth and neonatal mortality.

Results: All prenatal and predelivery models had predictive accuracy for both intrapartum stillbirth and neonatal mortality with AUC values 0.71 or less. Five of 6 models for neonatal mortality based on delivery/day 1 and postdelivery/day 2 had increased predictive accuracy with AUC values greater than 0.80. Birth weight was the most important predictor for neonatal death in both postdelivery scenarios with independent predictive ability with AUC values of 0.78 and 0.76, respectively. The addition of 4 other top predictors increased AUC to 0.83 and 0.87 for the postdelivery scenarios, respectively.

Conclusions And Relevance: Models based on prenatal or predelivery data had predictive accuracy for intrapartum stillbirths and neonatal mortality of AUC values 0.71 or less. Models that incorporated delivery data had good predictive accuracy for risk of neonatal mortality. Birth weight was the most important predictor for neonatal mortality.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.26750DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7675108PMC
November 2020

Antenatal Dexamethasone for Early Preterm Birth in Low-Resource Countries.

N Engl J Med 2020 12 23;383(26):2514-2525. Epub 2020 Oct 23.

The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).

Background: The safety and efficacy of antenatal glucocorticoids in women in low-resource countries who are at risk for preterm birth are uncertain.

Methods: We conducted a multicountry, randomized trial involving pregnant women between 26 weeks 0 days and 33 weeks 6 days of gestation who were at risk for preterm birth. The participants were assigned to intramuscular dexamethasone or identical placebo. The primary outcomes were neonatal death alone, stillbirth or neonatal death, and possible maternal bacterial infection; neonatal death alone and stillbirth or neonatal death were evaluated with superiority analyses, and possible maternal bacterial infection was evaluated with a noninferiority analysis with the use of a prespecified margin of 1.25 on the relative scale.

Results: A total of 2852 women (and their 3070 fetuses) from 29 secondary- and tertiary-level hospitals across Bangladesh, India, Kenya, Nigeria, and Pakistan underwent randomization. The trial was stopped for benefit at the second interim analysis. Neonatal death occurred in 278 of 1417 infants (19.6%) in the dexamethasone group and in 331 of 1406 infants (23.5%) in the placebo group (relative risk, 0.84; 95% confidence interval [CI], 0.72 to 0.97; P = 0.03). Stillbirth or neonatal death occurred in 393 of 1532 fetuses and infants (25.7%) and in 444 of 1519 fetuses and infants (29.2%), respectively (relative risk, 0.88; 95% CI, 0.78 to 0.99; P = 0.04); the incidence of possible maternal bacterial infection was 4.8% and 6.3%, respectively (relative risk, 0.76; 95% CI, 0.56 to 1.03). There was no significant between-group difference in the incidence of adverse events.

Conclusions: Among women in low-resource countries who were at risk for early preterm birth, the use of dexamethasone resulted in significantly lower risks of neonatal death alone and stillbirth or neonatal death than the use of placebo, without an increase in the incidence of possible maternal bacterial infection. (Funded by the Bill and Melinda Gates Foundation and the World Health Organization; Australian and New Zealand Clinical Trials Registry number, ACTRN12617000476336; Clinical Trials Registry-India number, CTRI/2017/04/008326.).
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http://dx.doi.org/10.1056/NEJMoa2022398DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7660991PMC
December 2020

Growth from Birth Through Six Months for Infants of Mothers in the "Women First" Preconception Maternal Nutrition Trial.

J Pediatr 2021 02 18;229:199-206.e4. Epub 2020 Sep 18.

RTI International, Durham, NC.

Objective: To evaluate whether the fetal linear growth effects of maternal nutrition supplementation would be maintained through 6 months postnatal age.

Study Design: The Women First trial was a multicountry, individually randomized clinical trial that compared the impact of maternal nutrition supplementation initiated preconception (Arm 1) vs at ∼11 weeks of gestation (Arm 2), vs no supplement (Arm 3); the intervention was discontinued at delivery. Trial sites were in Democratic Republic of Congo, Guatemala, India, and Pakistan. Analysis includes 2421 infants born to 2408 randomized women. Primary outcome was the trajectory of length-for-age z scores (LAZ) by arm, based on assessments at birth and 1, 3, and 6 months. We fitted longitudinal models on growth from birth to 6 months using generalized estimating equations; maternal intervention effects were evaluated, adjusting for site and baseline maternal covariates.

Results: Linear growth for Arms 1 and 2 was statistically greater than for Arm 3 in 3 of the 4 countries, with average pairwise mean differences in LAZ of 0.25 (95% CI 0.15-0.35; P < .001) and 0.19 (95% CI 0.09-0.28; P < .001), respectively. Compared with Arm 3, average overall adjusted relative risks (95% CI) for stunting (LAZ <-2) were lower for Arms 1 and 2: 0.76 (0.66-0.87; P < .001) and 0.77 (0.67-0.88; P < .001), respectively.

Conclusions: Improved linear growth in early infancy observed for the 2 intervention arms supports the critical importance of maternal nutrition before conception and in the early phase of gestation.

Trial Registration: ClinicalTrials.gov: NCT01883193.
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http://dx.doi.org/10.1016/j.jpeds.2020.09.032DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7855785PMC
February 2021
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