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

Abstract

Objectives To update the Ghana PrenaBelt Trial’s (GPT) primary outcome data with the latest fetal growth standard and reanalyse it. To estimate the posterior probability, under various clinically relevant prior probabilities, of maternal nightly positional therapy (PT) throughout the third-trimester having a beneficial effect on customised birth weight centile (CBWC) using Bayesian analyses.Design A reanalysis of a double-blind, sham-controlled, randomised clinical trial.Setting A single, tertiary-level centre in Accra, Ghana.Participants Two-hundred participants entered, 181 completed and 167 were included in the final analysis. Participants were Ghanaian, healthy, aged 18–35 years, with low-risk, singleton pregnancies in their third-trimester, with Body Mass Index<35 kg/m2 at the first antenatal appointment for the index pregnancy and without known fetal abnormalities, pregnancy complications or medical conditions complicating sleep.Interventions Participants were randomised to receive treatment with either a PT or sham-PT device.Primary and secondary outcome measures The primary outcome was the CBWC using the latest Perinatal Institute, Gestation-Related Optimal Weight calculator. Using Bayesian methods, posterior probabilities of achieving a greater than 0%, 5% and 10% benefit in CBWC with PT were estimated. There was no secondary outcome.Results The median (IQR) CBWC was 42% (15–71) and 28% (9–52) in the PT and sham-PT groups, respectively (difference 8.4%; 95% CI −0.30 to 18.2; p=0.06). For achieving a >0%, >5% and >10% gain in CBWC with PT, the posterior probabilities were highly probable, probable and unlikely, respectively, given a range of prior probabilities reflecting varying degrees of pre-existing enthusiasm and scepticism.Conclusions Maternal nightly PT throughout the third-trimester did not have a statistically significant effect on CBWC on a frequentist analysis using the latest fetal growth standard. However, from a Bayesian analysis, clinicians can infer that PT is likely to benefit fetal growth but with a modest effect size.Trial registration number NCT02379728.