The Ghana PrenaBelt trial: a double-blind, sham-controlled, randomised clinical trial to evaluate the effect of maternal positional therapy during third-trimester sleep on birth weight

ObjectiveTo evaluate the effect, on birth weight and birth weight centile, of use of the PrenaBelt, a maternal positional therapy device, during sleep in the home setting throughout the third trimester of pregnancy.DesignA double-blind, sham-controlled, randomised clinical trial.SettingConducted from September 2015 to May 2016, at a single, tertiary-level centre in Accra, Ghana.ParticipantsTwo-hundred participants entered the study. One-hundred-eighty-one participants completed the study. Participants were women, 18 to 35 years of age, with low-risk, singleton, pregnancies in their third-trimester, with body mass index