Maternal positional therapy for fetal growth and customised birth weight centile benefit in a Bayesian reanalysis of a double-blind, sham-controlled, randomised clinical trial

• DOI: 10.1136/bmjopen-2023-078315
• Publication Date: 2024-04-29T07:00:28Z
• Authors: Jerry Coleman; Sahibjot Grewal; Jane Warland; Sebastian Hobson; Kuan Liu; Allan Kember
• Keywords: Adult; Adolescent; Pregnancy Trimester, Third; R; Infant, Newborn; Bayes Theorem; Ghana; Fetal Development; Young Adult; 03 medical and health sciences; 0302 clinical medicine; Double-Blind Method; Pregnancy; Obstetrics and Gynaecology; Medicine; Humans; Birth Weight; Female

Objectives To update the Ghana PrenaBelt Trial’s (GPT) primary outcome data with latest fetal growth standard and reanalyse it. estimate posterior probability, under various clinically relevant prior probabilities, of maternal nightly positional therapy (PT) throughout third-trimester having a beneficial effect on customised birth weight centile (CBWC) using Bayesian analyses. Design A reanalysis double-blind, sham-controlled, randomised clinical trial. Setting single, tertiary-level centre in Accra, Ghana. Participants Two-hundred participants entered, 181 completed 167 were included final analysis. Ghanaian, healthy, aged 18–35 years, low-risk, singleton pregnancies their third-trimester, Body Mass Index<35 kg/m 2 at first antenatal appointment for index pregnancy without known abnormalities, complications or medical conditions complicating sleep. Interventions to receive treatment either PT sham-PT device. Primary secondary measures The was CBWC Perinatal Institute, Gestation-Related Optimal Weight calculator. Using methods, probabilities achieving greater than 0%, 5% 10% benefit estimated. There no outcome. Results median (IQR) 42% (15–71) 28% (9–52) groups, respectively (difference 8.4%; 95% CI −0.30 18.2; p=0.06). For >0%, >5% >10% gain PT, highly probable, probable unlikely, respectively, given range reflecting varying degrees pre-existing enthusiasm scepticism. Conclusions Maternal did not have statistically significant frequentist analysis standard. However, from analysis, clinicians can infer that is likely but modest size. Trial registration number NCT02379728 .