Clinical epidemiology of easily recognisable congenital malformations in Gambian newborns: A descriptive cohort study embedded in a clinical trial

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Abstract Background The prevalence of congenital malformations remains high and significantly contributes to neonatal morbidity and mortality in West Africa. However, there is a gap in the existing literature regarding the clinical epidemiology of congenital malformations in the African subregion. This study aimed to describe the clinical presentation, prevalence, risk factors, and adverse neonatal outcomes of newborns with easily recognisable congenital malformations in urban Gambia. Methods This descriptive cohort study consisted of secondary analyses of a clinical trial data (PregnAnZi2 trial) for liveborn neonates delivered between October 2017 to May 2021 at two public health facilities in The Gambia. Congenital malformations were detected by clinical examination at birth with active and passive surveillance for 28 days after delivery. Congenital malformations were classified according to ICD11 definitions, with sub-classification into major or minor malformations as per WHO guidance. Results 140 out of 6750 neonates (2.1%) had at least one congenital malformation, with 29.3% (44/150) of these malformations classified as major. The musculoskeletal system was most frequently affected (58%, 87/150) with talipes equinovarus as the most common major malformation identified (43%, 19/44). A history of previous miscarriage was associated with an increased risk of congenital malformations (aOR 1.72, 95% CI 1.02 to 2.73, p value=0.04). Newborns with a congenital malformation were more likely to experience adverse neonatal outcomes than newborns without, with higher odds of low 1 minute Apgar score, (cOR 3.09, 95% CI 1.62 to 5.48, p <0.001), low 5 min Apgar score (cOR 6.10, 95% CI 2.10 to 14.62, p <0.001), hospitalisation during the neonatal period (cOR 4.42, 95% CI 2.77 to 6.83, p <0.001) and mortality within 24hrs of delivery (cOR 48.75, 95% CI 11.08 to 215.62, p <0.001). Among 70 neonatal deaths recorded by day 28 after birth, 15 (21.4%) were newborns with congenital malformation. The circulatory and skeletal systems were equally affected among congenital malformations recorded in neonatal deaths by day 28 (23.8%, 5/21). Conclusion Despite a relatively low prevalence, easily recognisable congenital malformations are associated with substantial neonatal morbidity and mortality. Improved antenatal diagnosis of congenital malformations is urgently required to optimise delivery strategies and improve perinatal outcomes, especially for women experiencing previous miscarriage. Trial Registration NCT03199547: Clinicaltrials.gov. Registered on 23rd June 2017

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