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

Allan J Kember, Heather M Scott, Louise M O'Brien, Ali Borazjani, Michael B Butler, Jesse H Wells, Andre Isaac, Kaishin Chu, Jerry Coleman, Debra L Morrison, Allan J Kember, Heather M Scott, Louise M O'Brien, Ali Borazjani, Michael B Butler, Jesse H Wells, Andre Isaac, Kaishin Chu, Jerry Coleman, Debra L Morrison

Abstract

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.

Keywords: fetal medicine; maternal medicine; respiratory physiology; sleep medicine; stillbirth.

Conflict of interest statement

Competing interests: AJK and AB are officers at GIRHL, which has a patent application for the PrenaBelt (#WO2016176632A1) on which AJK, AB and KC are listed as inventors. DLM reports grants from Bresotec and grants from CIHR/Industry Grant (Phillips) outside the submitted work. HMS, JC, JHW, MBB, AI and LMO have declared no support from any organisation for the submitted work, no financial relationships with any organisations that might have an interest in the submitted work in the previous three years, and no other relationships or activities that could appear to have influenced the submitted work.

© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Photos of the PrenaBelt (left side, back and front view) and a schematic showing the PrenaBelt laid flat (front and back view).
Figure 2
Figure 2
Enrolment, allocation and analysis of trial participants. PSG, polysomnogram.
Figure 3
Figure 3
Scatter plot of proportion of sleep time supine (%) versus intervention (PrenaBelt, sham) for each participant. Each line represents one participant.
Figure 4
Figure 4
Bland-Altman plot for percentage of time spent sleeping on the left side; difference between self-reported estimate and PSG-determined values. Broken lines indicate mean difference and upper and lower limits of agreement (95% CI). PSG, polysomnogram.
Figure 5
Figure 5
Bland-Altman plot for percentage of time spent sleeping supine; difference between self-reported estimate and PSG-determined values. Broken lines indicate mean difference and upper and lower limits of agreement (95% CI). Each short red line indicates an additional data point at that location (sunflower plot). PSG, polysomnogram.
Figure 6
Figure 6
Bland-Altman plot for percentage of time spent sleeping on the right side; difference between self-reported estimate and PSG-determined values. Broken lines indicate mean difference and upper and lower limits of agreement (95% CI). Each short red line indicates an additional data point at that location (sunflower plot). PSG, polysomnogram.

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