Publications by authors named "Patricia L Hibberd"

141 Publications

Assessing the Respiratory Effects of Air Pollution from Biomass Cookstoves on Pregnant Women in Rural India.

Int J Environ Res Public Health 2020 12 29;18(1). Epub 2020 Dec 29.

Department of Global Health, Boston University School of Public Health, Boston, MA 02118, USA.

Background: In India, biomass fuel is burned in many homes under inefficient conditions, leading to a complex milieu of particulate matter and environmental toxins known as household air pollution (HAP). Pregnant women are particularly vulnerable as they and their fetus may suffer from adverse consequences of HAP. Fractional exhaled nitric oxide (FeNO) is a noninvasive, underutilized tool that can serve as a surrogate for airway inflammation. We evaluated the prevalence of respiratory illness, using pulmonary questionnaires and FeNO measurements, among pregnant women in rural India who utilize biomass fuel as a source of energy within their home.

Methods: We prospectively studied 60 pregnant women in their 1st and 2nd trimester residing in villages near Nagpur, Central India. We measured FeNO levels in parts per billion (ppb), St. George's Respiratory Questionnaire (SGRQ-C) scores, and the Modified Medical Research Council (mMRC) Dyspnea Scale. We evaluated the difference in the outcome distributions between women using biomass fuels and those using liquefied petroleum gas (LPG) using two-tailed t-tests.

Results: Sixty-five subjects (32 in Biomass households; 28 in LPG households; 5 unable to complete) were enrolled in the study. Age, education level, and second-hand smoke exposure were comparable between both groups. FeNO levels were higher in the Biomass vs. LPG group (25.4 ppb vs. 8.6 ppb; -value = 0.001). There was a difference in mean composite SGRQ-C score (27.1 Biomass vs. 10.8 LPG; -value < 0.001) including three subtotal scores for Symptoms (47.0 Biomass vs. 20.2 LPG; -value< 0.001), Activity (36.4 Biomass vs. 16.5 LPG; -value < 0.001) and Impact (15.9 Biomass vs. 5.2 LPG; -value < 0.001). The mMRC Dyspnea Scale was higher in the Biomass vs. LPG group as well (2.9 vs. 0.5; < 0.001).

Conclusion: Increased FeNO levels and higher dyspnea scores in biomass-fuel-exposed subjects confirm the adverse respiratory effects of this exposure during pregnancy. More so, FeNO may be a useful, noninvasive biomarker of inflammation that can help better understand the physiologic effects of biomass smoke on pregnant women. In the future, larger studies are needed to characterize the utility of FeNO in a population exposed to HAP.
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http://dx.doi.org/10.3390/ijerph18010183DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7795669PMC
December 2020

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

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

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

Does distance from a clinic and poverty impact visit adherence for noncommunicable diseases? A retrospective cohort study using electronic medical records in rural Haiti.

BMC Public Health 2020 Oct 14;20(1):1545. Epub 2020 Oct 14.

Boston Medical Center, 72 East Concord St., Boston, MA, 02118, USA.

Background: Adherence to regular outpatient visits is vital to managing noncommunicable diseases (NCDs), a growing burden in low and middle-income countries. We characterized visit adherence among patients with NCDs in rural Haiti, hypothesizing higher poverty and distance from the clinic were associated with lower adherence.

Methods: We analyzed electronic medical records from a cohort of adults in an NCD clinic in Mirebalais, Haiti (April 2013 to June 2016). Visit adherence was: 1) visit constancy (≥1 visit every 3 months), 2) no gaps in care (> 60 days between visits), 3) ≥1 visit in the last quarter, and 4) ≥6 visits per year. We incorporated an adapted measure of intensity of multidimensional poverty. We calculated distance from clinic as Euclidean distance or self-reported transit time. We used multivariable logistic regressions to assess the association between poverty, distance, and visit adherence.

Results: We included 463 adult patients, mean age 57.8 years (SE 2.2), and 72.4% women. Over half of patients had at least one visit per quarter (58.1%), but a minority (19.6%) had no gaps between visits. Seventy percent of patients had a visit in the last quarter, and 73.9% made at least 6 visits per year. Only 9.9% of patients met all adherence criteria. In regression models, poverty was not associated with any adherence measures, and distance was only associated with visit in the last quarter (OR 0.87, 95% CI [0.78 to 0.98], p = 0.03) after adjusting for age, sex, and hardship financing.

Conclusions: Visit adherence was low in this sample of adult patients presenting to a NCD Clinic in Haiti. Multidimensional poverty and distance from clinic were not associated with visit adherence measures among patients seen in the clinic, except for visit in the last quarter. Future research should focus on identifying and addressing barriers to visit adherence.
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http://dx.doi.org/10.1186/s12889-020-09652-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7556963PMC
October 2020

Early identification of preterm neonates at birth with a Tablet App for the Simplified Gestational Age Score (T-SGAS) when ultrasound gestational age dating is unavailable: A validation study.

PLoS One 2020 31;15(8):e0238315. Epub 2020 Aug 31.

Department of Global Health, Boston University School of Public Health, Boston, Massachusetts Avenue, United States of America.

Background: In low resource settings recall of the date of the mother's last menstrual period may be unreliable and due to limited availability of prenatal ultrasound, gestational age of newborns may not be assessed reliably. Preterm babies are at high risk of morbidity and mortality so an alternative strategy is to identify them soon after birth is needed for early referral and management.

Objective: The objective of this study was to assess the accuracy in assessing prematurity of newborn, over and above birthweight, using a pictorial Simplified Gestational Age Score adapted for use as a Tablet App.

Methods: Two trained nurse midwives, blinded to each other's assessment and the actual gestational age of the baby used the app to assess gestational age at birth in 3 hospitals based on the following 4 parameters-newborn's posture, skin texture, breast and genital development. Inter-observer variation was evaluated and the optimal scoring cut-off to detect preterm birth was determined. Sensitivity and specificity of gestational age score using the tablet was estimated using combinations of last menstrual period and ultrasound as reference standards to assess preterm birth. The predictive accuracy of the score using the area under a receiver operating characteristic curve was also determined. To account for potential reference standard bias, we also evaluated the score using latent class models.

Results: A total of 8,591 live singleton births whose gestational age by last menstrual period and ultrasound was within 1 weeks of each other were enrolled. There was strong agreement between assessors (concordance correlation coefficient 0.77 (95% CI 0.76-0.78) and Fleiss' kappa was 0.76 (95% CI 0.76-0.78). The optimal cut-off for the score to predict preterm was 13. Irrespective of the reference standard, the specificity of the score was 90% and sensitivity varied from 40-50% and the predictive accuracy between 74%-79% for the reference standards. The likelihood ratio of a positive score varied between 3.75-4.88 while the same for a negative likelihood ratio consistently varied between 0.57-0.72. Latent class models showed similar results indicating no reference standard bias.

Conclusion: Gestational age scores had strong inter-observer agreement, robust prediction of preterm births simplicity of use by nurse midwives and can be a useful tool in resource-limited scenarios.

Trial Registration: The Tablet App for the Simplified Gestational Age Score (T-SGAS) study was registered at ClinicalTrials.gov NCT02408783.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0238315PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7458295PMC
October 2020

Caesarean birth by maternal request: a poorly understood phenomenon in low- and middle-income countries.

Int Health 2021 Jan;13(1):63-69

University of Colorado School of Medicine, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Room 4211, Aurora, CO 80045, USA.

Background: While trends in caesarean birth by maternal request in low- and middle-income countries are unclear, age, education, multiple gestation and hypertensive disease appear associated with the indication when compared with caesarean birth performed for medical indications.

Methods: We performed a secondary analysis of a prospectively collected population-based study of home and facility births using descriptive statistics, bivariate comparisons and multilevel mixed-effects logistic regression.

Results: Of 28 751 patients who underwent caesarean birth and had a documented primary indication for the surgery, 655 (2%) were attributed to caesarean birth by maternal request. The remaining 98% were attributed to maternal and foetal indications and prior caesarean birth. In a multilevel mixed effects logistic regression adjusted for site and cluster of birth, when compared with caesareans performed for medical indications, caesarean birth performed for maternal request had a higher odds of being performed among women ≥35 y of age, with a university or higher level of education, with multiple gestations and with pregnancies complicated by hypertension (P < 0.01). Caesarean birth by maternal request was associated with a two-times increased odds of breastfeeding within 1 h of delivery, but no adverse outcomes (when compared with women who underwent caesarean birth for medical indications; P < 0.01).

Conclusion: Caesarean performed by maternal request is more common in older and more educated women and those with multifoetal gestation or hypertensive disease. It is also associated with higher rates of breastfeeding within 1 h of delivery.
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http://dx.doi.org/10.1093/inthealth/ihaa020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7807237PMC
January 2021

Low-dose aspirin for the prevention of preterm delivery in nulliparous women with a singleton pregnancy (ASPIRIN): a randomised, double-blind, placebo-controlled trial.

Lancet 2020 01;395(10220):285-293

RTI International, Research Triangle Park, NC, USA.

Background: Preterm birth remains a common cause of neonatal mortality, with a disproportionately high burden in low-income and middle-income countries. Meta-analyses of low-dose aspirin to prevent pre-eclampsia suggest that the incidence of preterm birth might also be decreased, particularly if initiated before 16 weeks of gestation.

Methods: ASPIRIN was a randomised, multicountry, double-masked, placebo-controlled trial of low-dose aspirin (81 mg daily) initiated between 6 weeks and 0 days of pregnancy, and 13 weeks and 6 days of pregnancy, in nulliparous women with an ultrasound confirming gestational age and a singleton viable pregnancy. Participants were enrolled at seven community sites in six countries (two sites in India and one site each in the Democratic Republic of the Congo, Guatemala, Kenya, Pakistan, and Zambia). Participants were randomly assigned (1:1, stratified by site) to receive aspirin or placebo tablets of identical appearance, via a sequence generated centrally by the data coordinating centre at Research Triangle Institute International (Research Triangle Park, NC, USA). Treatment was masked to research staff, health providers, and patients, and continued until 36 weeks and 7 days of gestation or delivery. The primary outcome of incidence of preterm birth, defined as the number of deliveries before 37 weeks' gestational age, was analysed in randomly assigned women with pregnancy outcomes at or after 20 weeks, according to a modified intention-to-treat (mITT) protocol. Analyses of our binary primary outcome involved a Cochran-Mantel-Haenszel test stratified by site, and generalised linear models to obtain relative risk (RR) estimates and associated confidence intervals. Serious adverse events were assessed in all women who received at least one dose of drug or placebo. This study is registered with ClinicalTrials.gov, NCT02409680, and the Clinical Trial Registry-India, CTRI/2016/05/006970.

Findings: From March 23, 2016 to June 30, 2018, 14 361 women were screened for inclusion and 11 976 women aged 14-40 years were randomly assigned to receive low-dose aspirin (5990 women) or placebo (5986 women). 5780 women in the aspirin group and 5764 in the placebo group were evaluable for the primary outcome. Preterm birth before 37 weeks occurred in 668 (11·6%) of the women who took aspirin and 754 (13·1%) of those who took placebo (RR 0·89 [95% CI 0·81 to 0·98], p=0·012). In women taking aspirin, we also observed significant reductions in perinatal mortality (0·86 [0·73-1·00], p=0·048), fetal loss (infant death after 16 weeks' gestation and before 7 days post partum; 0·86 [0·74-1·00], p=0·039), early preterm delivery (<34 weeks; 0·75 [0·61-0·93], p=0·039), and the incidence of women who delivered before 34 weeks with hypertensive disorders of pregnancy (0·38 [0·17-0·85], p=0·015). Other adverse maternal and neonatal events were similar between the two groups.

Interpretation: In populations of nulliparous women with singleton pregnancies from low-income and middle-income countries, low-dose aspirin initiated between 6 weeks and 0 days of gestation and 13 weeks and 6 days of gestation resulted in a reduced incidence of preterm delivery before 37 weeks, and reduced perinatal mortality.

Funding: Eunice Kennedy Shriver National Institute of Child Health and Human Development.
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http://dx.doi.org/10.1016/S0140-6736(19)32973-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7168353PMC
January 2020

Duration of solid fuel cookstove use is associated with increased risk of acute lower respiratory infection among children under six months in rural central India.

PLoS One 2019 24;14(10):e0224374. Epub 2019 Oct 24.

Department of Global Health, Boston University School of Public Health, Boston, Massachusetts, United States of America.

Introduction: India has a higher number of deaths due to acute lower respiratory infections (ALRIs) in children <5 years than any other country. The underlying cause of half of ALRI deaths is household air pollution from burning of solid fuels, according to the World Health Organization. If there is a direct association between duration of exposure and increased ALRI risk, a potential strategy might be to limit the child's exposure to burning solid fuel.

Methods And Materials: Children born to pregnant women participating in the Global Network for Women and Children's Health Maternal and Newborn Health Registry near Nagpur, India were followed every two weeks from birth to six months to diagnose ALRI. The number of hours per day that the child's mother spent in front of a burning solid fuel cookstove was recorded. Children of mothers using only clean cookstoves were classified as having zero hours of exposure. Odds Ratios with 95% confidence intervals were obtained from Generalized Estimating Equations logistic models that assessed the relationship of exposure to solid fuels with risk of ≥1 ALRI, adjusted for sex of the child, household smoking, wealth, maternal age, birth weight and parity.

Results: Between August 2013 and March 2014, 302 of 1,586 children (19%) had ≥1 episode of ALRI. Results from the multivariable analysis indicate that the odds of ALRI significantly increased from 1.2 (95% CI: 0.7-2.2) for <1 hour of exposure to 2.1 (95% CI: 1.4-3.3) for >3 hours of exposure to solid fuel cookstoves compared with no exposure (p<0.01). Additionally, decreasing wealth [middle: 1.2 (0.9, 1.6); poor: 1.4 (1.2-1.7); p<0.001] was associated with ALRIs.

Conclusions: Our study findings indicate that increasing the time mothers spend cooking near solid fuel cookstoves while children are in the house may be associated with development of ≥1 ALRI in children <6 months.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0224374PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6812868PMC
March 2020

Household air pollution-related lung disease: protecting the children.

Thorax 2019 11;74(11):1018-1019

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

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http://dx.doi.org/10.1136/thoraxjnl-2019-214134DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6995330PMC
November 2019

Comparison of perinatal outcomes in facilities before and after Global Network's Helping Babies Breathe Implementation Study in Nagpur, India.

BMC Pregnancy Childbirth 2019 Sep 4;19(1):324. Epub 2019 Sep 4.

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

Background: The Helping Babies Breathe (HBB) educational program focuses on training of first-level birth attendants in neonatal resuscitation skills for the first minute of life (The Golden Minute). Pre-post studies of HBB implementation in sub-Saharan Africa and Asia have shown reductions in facility-based very early neonatal mortality and stillbirth rates. However, the Global Network pre-post HBB Implementation Study (GN-HBB-IS) found no difference in day 7 perinatal mortality rates (PMR-D7) among births to women participating in the Global Network's Maternal and Newborn Health Registry. To address potential differences in perinatal outcomes in births occurring in facilities that implemented HBB vs. all births occurring in the communities served by facilities that implemented HBB, we compared day-1 perinatal mortality rates (PMR-D1) among births occurring pre and post HBB implementation in facilities in Nagpur, India, one of the 3 sites participating in the GN-HBB-IS.

Methods: We hypothesized that there would be a 20% decrease in the Nagpur facility based PMR-D1 in the 12 months post GN HBB implementation from the pre-period. We explored pre-post differences in stillbirth rates (SBR) and day-1 neonatal mortality rates (NMR-D1).

Results: Of the 15 facilities trained for the GN-HBB-IS, 13 participated in the Nagpur HBB Facility Study (Nagpur-HBB-FS). There were 38,078 facility births in the 12 months before the GN-HBB-IS and 40,870 facility births in the 12 months after the GN-HBB-IS. There was 11% overlap between the registry births analyzed in the GN-HBB-IS and the facility births analyzed in the Nagpur-HBB-FS. In the Nagpur-HBB-FS, there was a pre-post reduction of 16% in PMR-D1 (p = 0.0001), a 14% reduction in SBR (p = 0.002) and a 20% reduction NMR-D1 (p = 0.006).

Conclusions: In the Nagpur-HBB-FS, PMR-D1, stillbirths and NMR-D1 were significantly lower after HBB implementation. These benefits did not translate to improvements in PMR-D7 in communities served by these facilities, possibly because facilities in which HBB was implemented covered an insufficient proportion of community births or because additional interventions are needed after day 1 of life. Further studies are needed to determine how to translate facility-based improvements in PMR-D1 to improved neonatal survival in the community.

Trial Registration: The Global Network HBB Implementation Study (GN-HBB-IS) was registered at ClinicalTrials.gov: NCT01681017 .
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http://dx.doi.org/10.1186/s12884-019-2480-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6724302PMC
September 2019

Trends and determinants of increasing caesarean sections from 2010 to 2013 in a prospective population-based registry in eastern rural Maharashtra, India.

BMJ Open 2019 08 5;9(8):e024654. Epub 2019 Aug 5.

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

Objective: Our objective was to describe trends in caesarean section (CS) rates, characteristics of women delivering by CS, reasons for CS and impact of CS on perinatal mortality, in a rural Indian population.

Design: Secondary data analysis using a prospective population-based registry.

Setting: Four districts in Eastern Maharashtra, India, 2010 to 2013.

Participants: 39 026 pregnant women undergoing labour and delivery.

Main Outcomes: CS, single most likely reason, perinatal mortality.

Results: Overall, 20% of the women delivered by CS. Rates increased from 17.4% in 2010 to 22.7% in 2013 (p<0.001) with an absolute risk increase from 1% to 5% during this time-period. Women aged 25+ years old, being nulliparous, having at least a secondary school education, a body mass index 25+ and a multiple gestation pregnancy were more likely to deliver by CS. Perinatal mortality was higher among babies delivered vaginally than those delivered by CS (4.5% vs 2.7%, p<0.001). Prolonged and obstructed labour as the reported reason for CS increased over time for both nulliparous and multiparous women (p<0.001), and 6% to 10% women had no clear reason for CS. Perinatal mortality was higher among babies born vaginally than those delivered by CS (adjusted OR: 0.65, 95% CI 0.56 to 0.76, p<0.001).

Conclusion: Rates of CS increased over time in rural Maharashtra, exceeding WHO recommendations. Characteristics associated with CS and outcomes of CS were similar to previous reports. Further studies are needed to ensure accuracy of reported reasons for CS, why obstructed and prolonged labour leading to CS is increasing in this population and what leads to CS without a clear indication. Such information may be helpful for implementing the Indian Government mandate that no CS be performed without strict medical indications, while ensuring that the overall CS rates are appropriate.

Trial Registration Number: NCT01073475.
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http://dx.doi.org/10.1136/bmjopen-2018-024654DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6687025PMC
August 2019

Trends of antenatal care during pregnancy in low- and middle-income countries: Findings from the global network maternal and newborn health registry.

Semin Perinatol 2019 08 16;43(5):297-307. Epub 2019 Mar 16.

Columbia University, New York, NY, United States.

Background: Antenatal care (ANC) is an important opportunity to diagnose and treat pregnancy-related complications and to deliver interventions aimed at improving health and survival of both mother and the infant. Multiple individual studies and national surveys have assessed antenatal care utilization at a single point in time across different countries, but ANC trends have not often been studied in rural areas of low-middle income countries (LMICs). The objective of this analysis was to study the trends of antenatal care use in LMICs over a seven-year period.

Methods: Using a prospective maternal and newborn health registry study, we analyzed data collected from 2011 to 2017 across five countries (Guatemala, India [2 sites], Kenya, Pakistan, and Zambia). Utilization of any ANC along with use of select services, including vitamins/iron, tetanus toxoid vaccine and HIV testing, were assessed. We used a generalized linear regression model to examine the trends of women receiving at least one and at least four antenatal care visits by site and year, controlling for maternal age, education and parity.

Results: Between January 2011 and December 2017, 313,663 women were enrolled and included in the analysis. For all six sites, a high proportion of women received at least one ANC visit across this period. Over the years, there was a trend for an increasing proportion of women receiving at least one and at least four ANC visits in all sites, except for Guatemala where a decline in ANC was observed. Regarding utilization of specific services, in India almost 100% of women reported receiving tetanus toxoid vaccine, vitamins/iron supplementation and HIV testing services for all study years. In Kenya, a small increase in the proportion of women receiving tetanus toxoid vaccine was observed, while for Zambia, tetanus toxoid use declined from 97% in 2011 to 89% in 2017. No trends for tetanus toxoid use were observed for Pakistan and Guatemala. Across all countries an increasing trend was observed for use of vitamins/iron and HIV testing. However, HIV testing remained very low (<0.1%) for Pakistan.

Conclusion: In a range of LMICs, from 2011 to 2017 nearly all women received at least one ANC visit, and a significant increase in the proportion of women who received at least four ANC visits was observed across all sites except Guatemala. Moreover, there were variations regarding the utilization of preventive care services across all sites except for India where rates were generally high. More research is required to understand the quality and influences of ANC.
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http://dx.doi.org/10.1053/j.semperi.2019.03.020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7027164PMC
August 2019

Early Identification of Preterm Neonates at Birth With a Tablet App for the Simplified Gestational Age Score (T-SGAS) When Ultrasound Gestational Age Dating Is Unavailable: Protocol for a Validation Study.

JMIR Res Protoc 2019 Mar 12;8(3):e11913. Epub 2019 Mar 12.

Department of Global Health, Boston University School of Public Health, Boston, MA, United States.

Background: Although rates of preterm birth continue to increase globally, identification of preterm from low birth weight infants remains a challenge. The burden of low birth weight vs preterm is greatest in resource-limited settings, where gestational age (GA) prior to delivery is frequently not known because ultrasound in early pregnancy is not available and estimates of the date of the mother's last menstrual period (LMP) may not be reliable. An alternative option is to assess GA at birth to optimize referral and care of preterm newborns. We previously developed and pilot-tested a system to measure the simplified gestational age score (SGAS) based on 4 easily observable neonatal characteristics.

Objective: The objective of this study is to adapt the scoring system as a tablet app (potentially scalable approach) to assess feasibility of use and to validate whether the scoring system accurately predicts prematurity by itself, over and above birth weight in a large sample of newborns.

Methods: The study is based in Nagpur, India, at the Research Unit of the National Institute of Child Health and Human Development's Global Network for Women's and Children's Health Research. The Android tablet app for the SGAS (T-SGAS) displays de-identified photographs of skin, breasts, and genitalia across a range of GAs and line drawings of infant posture. Each item is associated with a score. The user is trained to choose the photograph or line drawing that most closely matches the newborn being evaluated, and the app determines the neonate's GA category (preterm or term) from the cumulative score. The validation study will be conducted in 3 second level care facilities (most deliveries in India occur in hospitals, and women known to be at risk of preterm birth are referred to second level care facilities). Within 24 hours of delivery, women and their babies who are stable will be enrolled in the study. Two auxiliary nurse midwives (ANMs) blinded to prior GA assessments will use the T-SGAS to estimate the GA status of the newborn. An independent data collector will abstract the GA from the ultrasound recorded in the hospital chart and record the date of the mother's LMP. Eligibility for analysis is determined by the ultrasound and LMP data being collected within 1 week of each other to have a rigorous assessment of true GA.

Results: Publication of the results of the study is anticipated in 2019.

Conclusions: Until GA dating by ultrasound is universally available and easy to use in resource-limited settings, and where there are restrictions on ultrasound use due to their use for sex determination and abortion of female fetuses, this study will determine whether the T-SGAS app can accurately assess GA in risk categories at birth.

Trial Registration: ClinicalTrials.gov NCT02408783; https://clinicaltrials.gov/ct2/show/NCT02408783 (Archived by Webcite at http://www.webcitation.org/75S2kmr3T).

International Registered Report Identifier (irrid): DERR1-10.2196/11913.
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http://dx.doi.org/10.2196/11913DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6434403PMC
March 2019

Malpresentation in low- and middle-income countries: Associations with perinatal and maternal outcomes in the Global Network.

Acta Obstet Gynecol Scand 2019 03 20;98(3):300-308. Epub 2018 Dec 20.

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

Introduction: Uncertainty exists regarding the impact of malpresentation on pregnancy outcomes and the optimal mode of delivery in low- and middle-income countries. We sought to compare outcomes between cephalic and non-cephalic pregnancies.

Material And Methods: Using the NICHD Global Network's prospective, population-based registry of pregnancy outcomes from 2010 to 2016, we studied outcomes in 436 112 singleton pregnancies. Robust Poisson regressions were used to estimate the risk of adverse outcomes associated with malpresentation. We examined rates of cesarean delivery for malpresentation and compared outcomes between cesarean and vaginal delivery by region.

Results: Across all regions, stillbirth and neonatal mortality rates were higher among deliveries with malpresentation. In adjusted analysis, malpresentation was significantly associated with stillbirth (adjusted relative risk [aRR] 4.0, 95% confidence interval [CI] 3.7-4.5) and neonatal mortality (aRR 2.3, 95% CI 2.1-2.6). Women with deliveries complicated by malpresentation had higher rates of morbidity and mortality. Rates of cesarean delivery for malpresentation ranged from 27% to 87% among regions. Compared with cesarean delivery, vaginal delivery for malpresentation was associated with increased maternal risk, especially postpartum hemorrhage (aRR 5.0, 95% CI; 3.6-7.1).

Conclusions: In a cohort of deliveries in low- and middle-income countries, malpresentation was associated with increased perinatal and maternal risk. Further research is needed to determine the best management of these pregnancies.
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http://dx.doi.org/10.1111/aogs.13502DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6422525PMC
March 2019