Work

Protecting mothers and their infants through screening and comprehensive management of sexually transmitted infections in antenatal care in Zimbabwe (PROMISE): study protocol for an open label individually randomised controlled trial

Year: 2026

Type: article

Abstract: Introduction Observational studies suggest that sexually transmitted infections (STIs) during pregnancy are associated with a range of adverse outcomes for both mothers and babies, including preterm birth, low birth weight, and stillbirth. Furthermore, studies have shown a higher prevalence of STIs among those living with HIV. In low-resource settings, syndromic STI management is the standard approach which has low sensitivity as more than 80% of curable STIs are asymptomatic. The PROMISE trial evaluates whether screening and comprehensive management of three curable STIs, Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis, integrated into standard antenatal care can reduce adverse maternal and neonatal outcomes in a high HIV/STI prevalence setting. Methods and analysis PROMISE is an individually randomised controlled trial conducted in 14 antenatal clinics in Harare, Zimbabwe. Women are eligible if at <24 weeks gestation, confirmed by ultrasound. Women in the intervention arm receive screening for the three STIs two times during pregnancy (at <24 and at 32–34 weeks’ gestation), with treatment and partner management for those with positive test results. Women in the control arm and symptomatic women in the intervention arm receive standard of care (syndromic management). The primary outcome is a composite of preterm birth (<37 weeks’ gestation), low birth weight (<2500 g), and stillbirth (born ≥22 weeks without sign of life). Secondary outcomes include individual components of the composite outcome, prelabour rupture of membranes, babies that are small for gestational age, neonatal death or conjunctivitis in babies within the first 6 weeks of birth. The planned sample size is 12 780 pregnant women (6390 per arm). A cost-effectiveness analysis will estimate the incremental cost per disability-adjusted life year averted. A process evaluation will explore acceptability, feasibility, contextual influences and system-level considerations for scale-up. Ethics and dissemination Ethical approval for the trial has been granted by the Medical Research Council of Zimbabwe, the Biomedical Research and Training Institute Institutional Review Board, the Joint Research and Ethics Committee, the Sally Mugabe Central Hospital Ethics Committee and the London School of Hygiene & Tropical Medicine Research Ethics Committee. Findings will be disseminated through peer-reviewed publications, conference presentations, engagement with national and international policymakers and community dissemination workshops co-developed with the trial’s Community Advisory Board. Trial registration number PACTR202505577399427 (Pan-African Clinical Trials Registry).

Source: BMJ Open

DOI: 10.1136/bmjopen-2026-126249