Modifying maternal sleep position in the third trimester of pregnancy with positional therapy: a randomised 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, randomised, sham-controlled, cross-over pilot trial.

Setting

Conducted between March 2016 and January 2017, at a single, tertiary-level centre in Canada.

Participants

23 participants entered the study. 20 participants completed the study. Participants were low-risk, singleton, third-trimester pregnant women aged 18 years and older 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

A two-night, polysomnography study in a sleep laboratory. Participants were randomised by computer-generated, one-to-one, simple randomisation to receive either a PrenaBelt or a sham-PrenaBelt on the first night and were crossed over to the alternate device on the second 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 number

NCT02377817; Results.

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