Capability and feasibility of the Global Alignment of Immunisation Safety Assessment in pregnancy criteria for the assessment of pregnancy and birth outcomes in Kinshasa, Democratic Republic of the Congo: a prospective cohort study

Abstract

Introduction There is an urgent need to investigate the capabilities of active surveillance in strengthening the development of pharmacovigilance (PV) systems in low-resource settings. Here, we assess the capability and feasibility of prospectively collected data to document maternal immunisation and adverse birth outcomes across delivery centres in Kinshasa, Democratic Republic of the Congo (DRC) according to the Global Alignment of Immunisation Safety Assessment in pregnancy (GAIA) definitions.Methods We conducted a facility-based prospective cohort study that enrolled mothers via convenience sampling either during their antenatal care visit or following their delivery. Demographic and clinical information as well as postpartum details related to the index pregnancy were collected after delivery; all mothers were also contacted via telephone 30 days postdelivery to determine if certain outcomes occurred after health facility discharge. Adverse birth outcomes of interest and maternal tetanus immunisation were categorised according to the GAIA criteria, and the level and impact of loss to follow-up (LTFU) was also evaluated.Results The study population consisted of 2675 mothers. The proportion of adverse birth outcomes ranged from 1.6% (for neonatal death) to 15.8% (for small for gestational age). Evidence of maternal tetanus immunisation during the index pregnancy was found for 637 mothers of newborns with any adverse birth outcome. GAIA diagnostic certainty was high for low birth weight and preterm birth, but much lower for stillbirth and neonatal bloodstream infections. Additionally, LTFU was high: only 47.9% of all mothers were successfully followed up via phone call.Conclusion Our investigation highlighted some of the challenges associated with the utilisation of the GAIA criteria in (prospective) observational studies within health facilities in Kinshasa, DRC (eg, data quality, LTFU and selection bias). Nevertheless, active surveillance remains a promising tool for future PV activities in DRC and beyond.