Data from: Modifying maternal sleep position in the third trimester of pregnancy with positional therapy: a randomized pilot trial

OBJECTIVE: To evaluate whether the percentage of time spent supine during sleep in the third trimester of pregnancy could be reduced using a positional therapy device (PrenaBelt) compared with a sham device.
DESIGN: A double-blind, randomized, sham-controlled, crossover pilot trial.
SETTING: Conducted between March 2016 and January 2017, at a single, tertiary-level center in Canada.
PARTICIPANTS: Twenty-three participants entered the study. Twenty participants completed the study. Participants were low-risk, singleton, third-trimester pregnant women aged 18 years and older with BMI <35 at the first antenatal appointment for the index pregnancy and without known fetal abnormalities, pregnancy complications, or medical conditions complicating sleep.
INTERVENTIONS: A two-night, polysomnography study in a sleep laboratory. Participants were randomized by computer-generated, one-to-one, simple randomization to receive either a the PrenaBelt or a sham-PrenaBelt on the 1st night and were crossed over to the alternate device on the 2nd night. Allocation concealment was by unmarked, security-tinted, sealed envelopes. Participants, the recruiter, and personnel involved in setting up, conducting, scoring, and interpreting the polysomnogram were blinded to allocation.
PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the percentage of time spent supine during sleep. Secondary outcomes included maternal sleep architecture, respiration, self-reported sleep position, and feedback.
RESULTS: The median percentage of sleep time supine was reduced from 16.4% on the sham night to 3.5% on the PrenaBelt night (pseudomedian=5.8, p=0.03). We were unable to demonstrate differences in sleep architecture or respiration. Participants underestimated the time they spent sleeping supine by 7.0%, and six (30%) participants indicated they would make changes to the PrenaBelt. There were no harms in this study.
CONCLUSIONS: This study demonstrates that the percentage of sleep time supine during late pregnancy can be significantly reduced via positional therapy.
TRIAL REGISTRATION: ClinicalTrials.gov NCT02377817