Purpose Stillbirth is a significant public health problem in India, yet comprehensive epidemiological data on its prevalence and risk factors are lacking. This initiative develops a pooled dataset from 10 well-characterized pregnancy cohorts across urban and rural India to estimate the national prevalence of stillbirths, identify risk factors and their population-attributable fractions, and develop a predictive risk stratification model for evidence-based clinical decision-making and interventions in high-risk pregnancies. Participants Pregnant women were recruited from the health facilities and community settings during the antenatal period. Recruitment spans four urban, four rural, and two mixed urban-rural sites, ensuring diversity in geographic and demographic representation. Findings to Date The ICMR stillbirth pooled India cohort (ICMR-SPIC) comprises 229,695 pregnant women. The mean (standard deviation) maternal Age at recruitment was 23.5(3.3) years. 30.5% were underweight (BMI <18.5 kg/m 2) and 16.8% were overweight or obese (BMI ≥23 kg/m 2). Short stature (<145 cm) was observed in 6.9% of participants. The mean (SD) gestational Age at birth was 38.7 (2.5) weeks. A third of the participants (33.3%) experienced moderate to severe anaemia during pregnancy (Hb<9.5g/dL), 52.8% were multiparous, and 22.5% conceived within 18 months of their previous childbirth. Core maternal risk factors such as short stature, BMI, parity, prior stillbirths, and anaemia during pregnancy were recorded in all cohorts. Additional variables, including gestational weight gain, preeclampsia/eclampsia, antepartum hemorrhage, and fetal distress, were available for over 80% of the cohorts, ensuring robust data coverage for risk factor analysis and modeling. Future Plans ICMR-SPIC will be used to conduct individual-level pooled data analyses to estimate prevalence, identify key risk factors, and develop predictive models for stillbirths. Findings will inform policies, clinical guidelines, and targeted interventions for high-risk pregnancies. The harmonized ICMR-SPIC dataset is a landmark collaborative effort to advance maternal and newborn health in India.
Competing Interest StatementThe authors have declared no competing interest.
Funding StatementThis study was funded by the Indian Council of Medical Research to create a harmonised pooled dataset across ten pregnancy cohorts in India and to conduct secondary analysis using this dataset.
Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
Ethics committee approval was taken by each of the PIs before contributing data for this pooled data analysis. ICMR had a data sharing agreement with all the Principal Investigators sharing data for the analysis. Ten investigator groups managing pregnancy cohorts joined the ICMR-SPIC consortium; details are provided in Supplementary Table 2. The consortium commenced its work in April 2024 after confirming the involvement of researchers, the availability of ethics and regulatory approvals, and signing agreements for sharing de-identified cohort data with the ICMR.
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
Yes
I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
Yes
Data AvailabilityAll contributing research teams have acknowledged that the pooled data can only be used for collaborative activities within the ICMR-SPIC consortium, with no transfer of ownership.
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