ArticleBMC pregnancy and childbirth2026
Clinical epidemiology of easily recognisable congenital malformations in Gambian newborns: a descriptive cohort study embedded in a clinical trial.
Article in BMC pregnancy and childbirth, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03199547 (Pre-delivery Administration of Azithromycin to Prevent Neonatal Sepsis and Death), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Pre-delivery Administration of Azithromycin to Prevent Neonatal Sepsis and Death: a Phase III Double-blind Randomized Clinical Trial
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19 authors.
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Abstract
backgroundThe 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.
methodsThis descriptive cohort study consisted of secondary analyses of a clinical trial data (PregnAnZi-2 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.
resultsOne hundred forty 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 (OR:1.72, 95%CI:1.02-2.73, 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-min Apgar score, (OR:3.09, 95%CI:1.62-5.48, p-value < 0.001), low 5-min Apgar score (OR:6.10, 95%CI:2.10-14.62, p-value < 0.001), hospitalisation during the neonatal period (OR:4.42, 95%CI:2.77-6.83, p-value < 0.001) and mortality within 24h of delivery (OR 48.75, 95%CI:11.08-215.62, p-value < 0.001). Among 70 neonatal deaths recorded by day 28 after birth in the study, 15 (21.4%) were newborns with congenital malformation. The circulatory and skeletal systems were equally more affected among congenital malformations recorded on neonatal deaths by day 28 after birth (23.8%, 5/21).
conclusionDespite a relatively low prevalence, easily recognisable congenital malformations are associated with substantial perinatal 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 registrationNCT03199547: Clinicaltrials.gov. Registered on 23rd June 2017 DOI: https://dx.doi.org/10.18203/2349-3259.ijct20220110.
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