Incidence and risks of adverse fetal and neonatal outcomes in the LABOR study, a prospective intrapartum cohort in four tertiary referral centers in Ghana, India, and Zambia

Abstract

Abstract Background Globally, more than two million perinatal deaths occur annually attributable to the intrapartum period, the vast majority occurring in low- and middle-income countries (LMICs). We sought to ascertain the incidence of adverse neonatal intrapartum-related outcomes and associated risk factors in tertiary referral centers in LMICs. Methods The Limiting Adverse Birth Outcomes in Resource-limited settings (LABOR) Study was a prospective intrapartum observational cohort of women and their fetuses in Ghana, India and Zambia enrolled from 2019 to 2022 and followed through 42 days postpartum. Women with a singleton pregnancy admitted to the labor ward for a vaginal birth were eligible for inclusion; additionally, women admitted for a cesarean birth were eligible if they also had signs/symptoms of labor, elevated blood pressure or fever on admission. Among the 16,369 eligible participants, all 16,369 were approached; of these, 2315 refused and 1982 were excluded. Of the 12,072 enrolled, we excluded an additional 1736 with pre-labor Cesarean birth, analyzing a cohort of 10,336 women for this manuscript. Our primary outcome was a composite of these secondary outcomes: intrapartum stillbirth, neonatal death, intrapartum-related neonatal encephalopathy and culture-proven early onset neonatal sepsis. We estimated the incidence of outcomes using binomial proportions and the adjusted risk of outcomes associated with baseline factors using generalized linear models. Results We included 10,336 women with a median age of 27; 1788 (17·3%) had preeclampsia, 181 (1·8%) had ante/intrapartum hemorrhage, 255 (2·5%) had chorioamnionitis, 3235 (31·3%) of the women gave birth via Cesarean and 1818 (17·6%) were preterm births at < 37 weeks. The overall incidence of the primary outcome was 42/1000 births (95% CI: 38, 46). Ten per 1000 births (95% CI 8, 12) were intrapartum stillbirths, 24/1000 live births (95% CI 21, 27) were neonatal deaths, 7/1000 (95% CI 6, 9) had intrapartum-related encephalopathy and 5/1000 (95% CI 4, 7) had culture-proven sepsis. Maternal co-morbidities increased the risk of the primary outcome (preeclampsia/eclampsia aRR 2·7; 95% CI 2·4, 2·9, ante/intrapartum hemorrhage aRR 4·0; 95% CI 3·2, 5·1, chorioamnionitis aRR 2·8; 95% CI 2·4, 3·4), as did preterm birth aRR 7·1; 95% CI 4·2, 11·8. Conclusions and relevance The LABOR study provides detailed estimates of adverse intrapartum-related neonatal outcomes in tertiary referral centers in LMICs. Given the high prevalence of both preeclampsia and preterm birth and their strong associations with adverse neonatal outcomes, prevention and treatment of maternal hypertensive disorders and preterm birth are high public health priorities. Trial registration Clinicaltrials.gov (United States): NCT04102644 (Registration Date: 2019-09-25). Clinical Trial Registry of India (India): CTRI/2020/01/022589.