Detection and risk stratification of women at high risk of preterm birth in rural communities near Nagpur, India.

BACKGROUND: Presently, preterm birth is globally the leading cause of neonatal mortality. Prompt community based identification of women at high risk for preterm births (HRPB) can either help to avert preterm births or avail effective interventions to reduce neonatal mortality due to preterm births. We evaluated the performance of a package to train community workers to detect the presence of signs or symptoms of HRPB. METHODS: Pregnant women enrolled in the intervention arm of a cluster randomized trial of Antenatal Corticosteroids (ACT Trial) conducted at Nagpur, India were informed about 4 directly observable signs and symptoms of preterm labor. Community health workers actively monitored these women from 24 to 36 weeks of gestation for these signs or symptoms. If they were present (HRPB positive) the identified women were brought to government health facilities for assessment and management. HRPB positive could also be determined by the provider if the woman presented directly to the facility. Risk stratification was based on the number of signs or symptoms present. The outcome of preterm birth was based on the clinical assessment of gestational age < 37 weeks at delivery or a birth weight of <2000 g. RESULTS: Between July 1, 2012 and 30 November, 2013, 686 of 7050 (9.7%) pregnant women studied, delivered preterm. 732 (10.4%) women were HRPB positive, of whom 333 (45.5%) delivered preterm. Of the remaining 6318(89.6%) HRPB negative women 353 (5.6%) delivered preterm. The likelihood ratio (LR) of a preterm birth in the HRPB positives was 8.14 (95% confidence interval 7.16-9.26). The LR of a preterm birth increased in women who had more signs or symptoms of HRBP (p < 0.00001). More signs or symptoms of HRPB were also associated with a shorter time to delivery, lower birth weight and higher rates of stillbirths, neonatal deaths and postnatal complications. Addition of risk stratification improved the prediction of preterm delivery (Integrated Discrimination Improvement 17% (95% CI 15-19%)). CONCLUSIONS: The package for detection of signs and symptoms of HRPB is feasible, promising and likely to improve management of preterm labor. TRIAL REGISTRATION: NCT01073475 on February 21, 2010 and NCT01084096 on March 9, 2010.

Description of inter-institutional referrals after admission for labor and delivery: a prospective population based cohort study in rural Maharashtra, India.

BACKGROUND: In 2008, the Indian government introduced financial assistance to encourage health facility deliveries. Facility births have increased, but maternal and neonatal morbidity and mortality have not decreased raising questions about the quality of care provided in facilities and access to a quality referral system. We evaluated the potential role of inter-institutional transfers of women admitted for labor and delivery on adverse maternal and neonatal outcomes in an ongoing prospective, population-based Maternal and Newborn Health Registry in Central India. METHODS: Pregnant women from 20 rural Primary Health Centers near Nagpur, Maharashtra were followed throughout pregnancy and to day 42 post-partum. Inter- institutional referral was defined as transfer of a woman from a first or second level facility where she was admitted for labor and delivery to facility providing higher level of care, after admission to the day of delivery. Maternal mortality, stillbirth, early and late neonatal mortality were compared in mothers who were and were not referred. Factors associated with inter-institutional referral were analyzed using multivariable models with generalized estimating equations, adjusted for clustering at the level of the Primary Health Center. RESULTS: Between June 2009 and June 2013, 3236 (9.4%) of 34,319 women had inter-institutional referral. Factors associated with referrals were maternal age (adjusted Relative Risk or aRR 1.1; 1.0-1.2); moderate or severe anemia (aRR 1.2; 1.2-1.4), gestational age <37 weeks (aRR 1.16; 1.05-1.27), multiple gestation (aRR 1.6; 1.2-2.1), absent fetal heart rate (aRR 1.7; 1.3-2.2), primigravida (aRR 1.4; 1.3, 1.6), primigravida with any pregnancy related maternal condition such as obstructed or prolonged labor; major antepartum or post-partum hemorrhage, hypertension or preeclampsia and breech, transverse or oblique lie (aRR 4.7; 3.8, 5.8), multigravida with any pregnancy related conditions (aRR 4.2; 3.4-5.2). Stillbirths, early neonatal,late neonatal and early infant deaths occurred in 7.3% referred mothers vs. 3.7% of not referred. CONCLUSIONS: Almost 10% of the women had an inter-institutional referral and still birth or neonatal deaths were doubled in referred women. Conditions associated with referral were often known before onset of labor and delivery. Improvements in maternal and neonatal outcomes will likely require pregnant women with conditions associated with referral to be directly admitted at facilities equipped to care for complicated pregnancies and at risk neonates, as well as prompt detection and transfer those who develop "at risk" conditions during labor and delivery. TRIAL REGISTRATION: ClinicalTrials.gov NCT01073475 .

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

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.

Maternal anemia and underweight as determinants of pregnancy outcomes: cohort study in eastern rural Maharashtra, India.

OBJECTIVES: To study the trend in the prevalence of anaemia and low BMI among pregnant women from Eastern Maharashtra and evaluate if low BMI and anaemia affect pregnancy outcomes. DESIGN: Prospective observational cohort study. SETTING: Catchment areas of 20 rural primary health centres in four eastern districts of Maharashtra State, India. PARTICIPANTS: 72 750 women from the Nagpur site of Maternal and Newborn Health Registry of NIH's Global Network, enrolled from 2009 to 2016. MAIN OUTCOME MEASURES: Mode of delivery, pregnancy related complications at delivery, stillbirths, neonatal deaths and low birth weight (LBW) in babies. RESULTS: Over 90% of the women included in the study were anaemic and over a third were underweight (BMI <18 kg/m2) and with both conditions. Mild anaemia at any time during delivery significantly increased the risk (Risk ratio; 95% confidence interval (RR;(95% CI)) of stillbirth (1.3 (1.1-1.6)), neonatal deaths (1.3 (1-1.6)) and LBW babies (1.1 (1-1.2)). The risks became even more significant and increased further with moderate/severe anaemia any time during pregnancy for stillbirth (1.4 (1.2-1.8)), neonatal deaths (1.7 (1.3-2.1)) and LBW babies (1.3 (1.2-1.4)).,. Underweight at anytime during pregnancy increased the risk of neonatal deaths (1.1 (1-1.3)) and LBW babies (1.2;(1.2-1.3)).The risk of having stillbirths (1.5;(1.2-1.8)), neonatal deaths (1.7;(1.3-2.3)) and LBW babies (1.5;(1.4-1.6)) was highest when - the anaemia and underweight co-existed in the included women. Obesity/overweight during pregnancy increased the risk of maternal complications at delivery (1.6;(1.5-1.7)) and of caesarean section (1.5;(1.4-1.6)) and reduced the risk of LBW babies 0.8 (0.8-0.9)). CONCLUSION: Maternal anaemia is associated with enhanced risk of stillbirth, neonatal deaths and LBW. The risks increased if anaemia and underweight were present simultaneously. TRIAL REGISTRATION NUMBER: NCT01073475.