Observational studyBMC pregnancy and childbirth2026
A multicountry study to establish rates for pregnancy and neonatal outcomes in low- and middle-income regions.
Observational study 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 NCT03614676 (A Prospective Epidemiological Study of Pregnancy Outcomes and of Events of Interest in Pregnant Women, Neonates and Infants), which is not on this map. Not yet cited in PubMed.
What it found
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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.
A Prospective Epidemiological Study of Pregnancy Outcomes and of Events of Interest in Pregnant Women, Neonates and Infants (PEPNI)
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
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Authors and funding
50 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMaternal vaccines can reduce the burden of diseases for both mother and neonate. The development and implementation of such vaccines require a thorough interpretation of safety data and standardized disease case definitions. This study aimed to evaluate the current rates for adverse pregnancy outcomes, maternal and neonatal events of interest (EOIs) that will be informative for preparing future phase III clinical trials on maternal vaccines conducted in low- and middle-income countries and further assisting in safety data interpretation (e.g., monitoring potential safety signals in clinical trials, and/or helping with the causality assessments of adverse events following immunization).
methodsWe performed a prospective cohort study on healthy 18-45-year-old women, with singleton, low-risk pregnancies, with a gestational age of ≥24
resultsOf 2311 pregnant women and 2181 neonates enrolled, 2222 and 2094 were included in the analyses, respectively. Most livebirths (2088 [94.0%]) were without apparent congenital anomalies. Preterm delivery (166 [7.5%]), non-reassuring fetal status (137 [6.2%]), and hypertensive disorders of pregnancy (125 [5.6%]) were the most frequently reported EOIs related to pregnancy. The most frequent neonatal EOIs were low birthweight (including very low birthweight) (156 [7.4%]), preterm birth (141 [6.7%]), small for gestational age (111 [5.3%]), and congenital anomalies (103 [4.9%], including mainly major external structural defects, as well as detected internal and functional defects). Overall, there were similar frequencies in pregnancy outcomes, pregnancy-related and neonatal EOIs across countries, although some variation in the reporting rate was noted.
conclusionThis multicountry study contributes to establishing the most recent background rates for pregnancy outcomes, maternal and neonatal EOIs in low- and middle-income regions. The clinical relevance in the context of the safety assessment in future trials will be applied.
trial registrationNCT03614676 (03/08/2018).
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