Abstract
BACKGROUND: The rate of caesarean sections (C-sections) is increasing globally, with many procedures being performed without clinical indication. We aimed to explore whether implementing the eight antenatal care visits that include health education and four ultrasonographic examinations (intervention group (IG)) recommended by the World Health Organization (WHO) would reduce unnecessary C-sections among Bangladeshi pregnant women in comparison to the usual four antenatal care and two ultrasonogram exams (comparison group (CG)) currently in use within the country's healthcare system. METHODS: We designed a randomised controlled trial that included two tertiary and two non-tertiary hospitals in Bangladesh. The randomisation was done at the hospital level, whereby we randomly allocated the hospitals to the IG or CG, with one tertiary and one non-tertiary hospital in each arm. We conducted this trial between November 2021 and December 2022. Pregnant women of all ages without any complications requiring C-sections were enrolled in the allocated IG and CG hospitals. The primary outcome was the reduction in the number of unnecessary C-sections. We considered unnecessary C-sections when there was no proper indication for caesarean delivery. Alongside descriptive analysis, we used adjusted log-linear regression models to investigate the relationship between unnecessary C-sections and various contributing factors. RESULTS: We enrolled 288 pregnant women from two intervention and two comparison hospitals, with 144 assigned to the IG and 144 to the CG (72 from each hospital). There were 183 complete, successful deliveries in total (50.27% in IG vs. 49.73% in CG; P = 0.903). Of these, 106 resulted in C-sections (39.62% in IG and 60.38% in CG; P = 0.001), with 70 assessed as being necessary (47.14% in IG and 52.86% in CG; P = 0.027) and 36 as being unnecessary (25% in IG and 75% in CG). There were significantly fewer unnecessary C-sections among the women in the IG (P = 0.027), who also had a significantly lower risk ratio of 0.64 (95% confidence interval = 0.54-0.77, P < 0.001) compared to the CG. CONCLUSIONS: Our findings indicate that the WHO-recommended antenatal visits and their interventions were effective in reducing unnecessary C-sections by 50%. REGISTRATION: Clinicaltrials.gov: NCT05135026.