Maternal and fetal factors associated with stillbirth in singleton pregnancies in 13 hospitals across six states in India: A prospective cohort study.

OBJECTIVE: This study aimed to investigate the incidence of and risk factors for stillbirth in an Indian population. METHODS: We conducted a secondary data analysis of a hospital-based cohort from the Maternal and Perinatal Health Research collaboration, India (MaatHRI), including pregnant women who gave birth between October 2018-September 2023. Data from 9823 singleton pregnancies recruited from 13 hospitals across six Indian states were included. Univariable and multivariable Poisson regression analysis were performed to examine the relationship between stillbirth and potential risk factors. Model prediction was assessed using the area under the receiver-operating characteristic (AUROC) curve. RESULTS: There were 216 stillbirths (48 antepartum and 168 intrapartum) in the study population, representing an overall stillbirth rate of 22.0 per 1000 total births (95% confidence interval [CI]: 19.2-25.1). Modifiable risk factors for stillbirth were: receiving less than four antenatal check-ups (adjusted relative risk [aRR]: 1.75, 95% CI: 1.25-2.47), not taking any iron and folic acid supplementation during pregnancy (aRR: 7.23, 95% CI: 2.12-45.33) and having severe anemia in the third trimester (aRR: 3.37, 95% CI: 1.97-6.11). Having pregnancy/fetal complications such as hypertensive disorders of pregnancy (aRR: 1.59, 95% CI: 1.03-2.36), preterm birth (aRR: 4.41, 95% CI: 3.21-6.08) and birth weight below the 10th percentile for gestational age (aRR: 1.35, 95% CI: 1.02-1.79) were also associated with an increased risk of stillbirth. Identified risk factors explained 78.2% (95% CI: 75.0%-81.4%) of the risk of stillbirth in the population. CONCLUSION: Addressing potentially modifiable antenatal factors could reduce the risk of stillbirths in India.

The complex relationship between iron status and anemia in pregnant and postpartum women in India: Analysis of two Indian study cohorts of uncomplicated pregnancies.

Low hemoglobin is widely used as an indicator of iron deficiency anemia in India and other low-and-middle income counties, but anemia need not accurately reflect iron deficiency. We examined the relationship between hemoglobin and biomarkers of iron status in antenatal and postnatal period. Secondary analysis of uncomplicated singleton pregnancies in two Indian study cohorts: 1132 antenatal women in third trimester and 837 postnatal women 12-72 h after childbirth. Associations of hemoglobin with ferritin in both data sets, and with sTfR, TSAT, and hepcidin in the postnatal cohort were examined using multivariable linear regression. Multinomial logistic regression was used to examine the association between severity of anemia and iron status. Regression models were adjusted for potential confounders. Over 55% of the women were anemic; 34% of antenatal and 40% of postnatal women had low ferritin, but 4% antenatal and 6% postnatal women had high ferritin. No evidence of association between hemoglobin and ferritin was observed (antenatal: adjusted coefficient [aCoef] -0.0004, 95% confidence interval [CI] -0.001, 0.001; postnatal: aCoef -0.0001, 95% CI -0.001, 0.001). We found a significant linear association of hemoglobin with sTfR (aCoef -0.04, 95% CI -0.07, -0.01), TSAT (aCoef -0.005, 95% CI -0.008, -0.002), and hepcidin (aCoef 0.02, 95% CI 0.02, 0.03) in postnatal women. Likelihood of low ferritin was more common in anemic than non-anemic women, but high ferritin was also more common in women with severe anemia in both cohorts. Causes of anemia in pregnant and postpartum women in India are multifactorial; low hemoglobin alone is not be a useful marker of iron deficiency.

Focused Cardiac Ultrasound to Guide the Diagnosis of Heart Failure in Pregnant Women in India.

BACKGROUND: Cardiac complications are a leading cause of maternal death. Cardiac imaging with echocardiography is important for prompt diagnosis, but it is not available in many low-resource settings. The aim of this study was to determine whether focused cardiac ultrasound performed by trained obstetricians and interpreted remotely by experts can identify cardiac abnormalities in pregnant women in low-resource settings. METHODS: A cross-sectional study was conducted among 301 pregnant and postpartum women recruited from 10 hospitals across three states in India. Twenty-two obstetricians were trained in image acquisition using a portable cardiac ultrasound device following a simplified protocol adapted from focus-assessed transthoracic echocardiography protocol. It included parasternal long-axis, parasternal short-axis, and apical four-chamber views on two-dimensional and color Doppler. Independent image interpretation was performed remotely by two experts, in the United Kingdom and India, using a standard semiquantitative assessment protocol. Interrater agreement between the experts was examined using Cohen's κ. Diagnostic accuracy of the method was examined in a subsample for whom both focused and conventional scans were available. RESULTS: Cardiac abnormalities identified using the focused method included valvular abnormalities (27%), rheumatic heart disease (6.6%), derangements in left ventricular size (4.7%) and function (22%), atrial dilatation (19.5%), and pericardial effusion (30%). There was substantial agreement on the cardiac parameters between the two experts, ranging from 93.6% (κ = 0.84) for left ventricular ejection fraction to 100% (κ = 1) for valvular disease. Image quality was graded as good in 79% of parasternal long-axis, 77% of parasternal short-axis and 64% of apical four-chamber views. The chance-corrected κ coefficients indicated fair to moderate agreement (κ = 0.28-0.51) for the image quality parameters. There was good agreement on diagnosis between the focused method and standard echocardiography (78% agreement), compared in 36 participants. CONCLUSIONS: The focused method accurately identified cardiac abnormalities in pregnant women and could be used for screening cardiac problems in obstetric settings.

Maternal and perinatal Health Research Collaboration, India (MaatHRI): methodology for establishing a hospital-based research platform in a low and middle income country setting.

Background: Maternal and perinatal Health Research collaboration, India (MaatHRI) is a research platform that aims to improve evidence-based pregnancy care and outcomes for mothers and babies in India, a country with the second highest burden of maternal and perinatal deaths. The objective of this paper is to describe the methods used to establish and standardise the platform and the results of the process. Methods: MaatHRI is a hospital-based collaborative research platform. It is adapted from the UK Obstetric Surveillance System (UKOSS) and built on a pilot model (IndOSS-Assam), which has been extensively standardised using the following methods: (i) establishing a network of hospitals; (ii) setting up a secure system for data collection, storage and transfer; (iii) developing a standardised laboratory infrastructure; and (iv) developing and implementing regulatory systems. Results: MaatHRI was established in September 2018. Fourteen hospitals participate across four states in India - Assam, Meghalaya, Uttar Pradesh and Maharashtra. The research team includes 20 nurses, a project manager, 16 obstetricians, two pathologists, a public health specialist, a general physician and a paediatrician. MaatHRI has advanced standardisation of data and laboratory parameters, real-time monitoring of data and participant safety, and secure transfer of data. Four observational epidemiological studies are presently being undertaken through the platform. MaatHRI has enabled bi-directional capacity building. It is overseen by a steering committee and a data safety and monitoring board, a process that is not normally used, but was found to be highly effective in ensuring data safety and equitable partnerships in the context of low and middle income countries (LMICs). Conclusion: MaatHRI is the first prototype of UKOSS and other similar platforms in a LMIC setting. The model is built on existing methods but applies new standardisation processes to develop a collaborative research platform that can be replicated in other LMICs.

IndOSS-Assam: investigating the feasibility of introducing a simple maternal morbidity surveillance and research system in Assam, India.

OBJECTIVE: To assess the feasibility of establishing a simple maternal morbidity surveillance system in Assam (Indian Obstetric Surveillance System-Assam (IndOSS-Assam)) to investigate the incidence and trends in severe maternal complications. This study presents the surveillance platform of IndOSS-Assam. DESIGN: Four tasks were undertaken: (1) setting up of a steering committee; (2) establishing priorities for the region; (3) mapping of surveillance sites; (4) piloting case-notification systems in selected centres. SETTING: Two government tertiary hospitals in the state. STUDY POPULATION: Pregnant women delivering in the hospitals between March and August 2015. MAIN OUTCOME MEASURES: Incidence and case fatality rates with 95% CIs. RESULTS: Local stakeholder ownership and a simple uncomplicated anonymous system for case notification were the key strengths of this project. Cases and deaths were reported for six conditions: eclampsia, postpartum haemorrhage, puerperal sepsis, septic abortion, uterine rupture and anaemic heart failure. Among 10 475 women delivering over 6 months, 402 had one of these conditions and 66 died (case fatality 16%). The incidence of eclampsia was 17 per 1000 deliveries (95% CI 14 to 19), postpartum haemorrhage was 11 per 1000 deliveries (95% CI 10 to 13) and anaemic heart failure was 3 per 1000 deliveries (95% CI 2 to 5). For each of the other three conditions-puerperal sepsis, septic abortion and uterine rupture-the incidence rate was 2 per 1000 deliveries. CONCLUSIONS: IndOSS-Assam was shown to be a feasible and simple system for ongoing surveillance of maternal morbidity that can be used to monitor the trends in the incidence of specific severe life-threatening conditions during pregnancy.

Association between maternal anaemia and pregnancy outcomes: a cohort study in Assam, India.

OBJECTIVES: To examine the association between maternal anaemia and adverse maternal and infant outcomes, and to assess the feasibility of conducting epidemiological studies through the Indian Obstetric Surveillance System-Assam (IndOSS-Assam). DESIGN: Retrospective cohort study using anonymised hospital records. Exposure: maternal iron deficiency anaemia; outcomes: postpartum haemorrhage (PPH), low birthweight, small-for-gestational age babies, perinatal death. SETTING: 5 government medical colleges in Assam. STUDY POPULATION: 1007 pregnant women who delivered in the 5 medical colleges from January to June 2015. MAIN OUTCOME MEASURES: ORs with 95% CIs to estimate the association between maternal iron deficiency anaemia and the adverse maternal and infant outcomes. Potential interactive roles of infections and induction of labour on the adverse outcomes were explored. RESULTS: 35% (n=351) pregnant women had moderate-severe anaemia. Women with severe anaemia had a higher odds of PPH (adjusted OR (aOR) =9.45; 95% CI 2.62 to 34.05), giving birth to low birthweight (aOR=6.19; 95% CI 1.44 to 26.71) and small-for-gestational age babies (aOR=8.72; 95% CI 1.66 to 45.67), and perinatal death (aOR=16.42; 95% CI 4.38 to 61.55). Odds of PPH increased 17-fold among women with moderate-severe anaemia who underwent induction of labour, and 19-fold among women who had infection and moderate-severe anaemia. CONCLUSIONS: Maternal iron deficiency anaemia is a major public health problem in Assam. Maternal anaemia was associated with increased risks of PPH, low birthweight, small-for-gestational age babies and perinatal death. While the best approach is prevention, a large number of women present with severe anaemia late in pregnancy and there is no clear guidance on how these women should be managed during labour and delivery.