Estimating baseline rates of adverse perinatal and neonatal outcomes using a facility-based surveillance approach: A prospective observational study from the WHO Global Vaccine Safety Multi-Country Collaboration on safety in pregnancy

• Published in: EClinicalMedicine Vol. 50; p. 101506
• Main Authors: Sharan, Apoorva, Stuurman, Anke L., Jahagirdar, Shubhashri, Elango, Varalakshmi, Riera-Montes, Margarita, Kashyap, Neeraj Kumar, Biccler, Jorne, Poluru, Ramesh, Arora, Narendra Kumar, Mathai, Mathews, Mangtani, Punam, Devlieger, Hugo, Anderson, Steven, Whitaker, Barbee, Wong, Hui-Lee, Moran, Allisyn, Maure, Christine Guillard
• Format: Journal Article
• Language: English
• Published: Elsevier Ltd 01.08.2022; Elsevier
• Subjects: Baseline rates; Minimum detectable risk; Neonatal outcomes; Perinatal outcomes; Pharmacovigilance; Surveillance; Vaccines; Perinatal outcomes; Surveillance; Neonatal outcomes; Baseline rates; Vaccines; Pharmacovigilance; Minimum detectable risk
• ISSN: 2589-5370; 2589-5370
• DOI: 10.1016/j.eclinm.2022.101506

Most perinatal and neonatal deaths occur in low- and middle-income countries (LMICs), yet, quality data on burden of adverse outcomes of pregnancy is limited in such countries. A network of 21 maternity units, across seven countries, undertook surveillance for low birthweight, preterm birth, small for gestational age (SGA), stillbirths, congenital microcephaly, in-hospital neonatal deaths, and neonatal infections in a cohort of over 85,000 births from May 2019 - August 2020. For each outcome, site-specific rates per 1,000 livebirths (or per 1,000 total births for stillbirth) and 95% confidence intervals (CI) were calculated. Descriptive sensitivity analysis was conducted to gain insight regarding underreporting of four outcomes at 16 sites. Estimated rates varied across countries and sites, ranging between 43·3-329·5 and 21·4-276·6/1000 livebirths for low birthweight and preterm birth respectively and 11·8-81/1,000 livebirths for SGA. No cases of congenital microcephaly were reported by three sites while the highest estimated rate was 13/1,000 livebirths. Neonatal infection and neonatal death rates varied between 1·8-73 and 0-59·9/1000 livebirths respectively while stillbirth rates ranged between 0-57·1/1000 total births across study sites. Results from the sensitivity analysis confirmed the underreporting of congenital microcephaly and SGA in our study. Our study establishes site-specific baseline rates for important adverse perinatal and neonatal outcomes and addresses a critical evidence gap towards improved monitoring of benefits and risks of emerging pregnancy and neonatal interventions. The study was sponsored by the World Health Organization with funding from the Bill and Melinda Gates Foundation.