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