Trial reportBMJ open2018
Modifying maternal sleep position in the third trimester of pregnancy with positional therapy: a randomised pilot trial.
Trial report in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Modifying Maternal Sleep Position in the Third Trimester of Pregnancy With Positional Therapy: A Randomized Pilot Trial
UniSA BackOff! Study: A Randomized, Controlled, Five-way, Cross-over Trial to Evaluate the Effect of a Positional Therapy Device on Maternal Sleeping Position in the Third Trimester of Pregnancy
Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Women's sleep position during pregnancy in low- and middle-income countries: a systematic review.Reproductive health · 2021Pooled it
- A Position Modification Device for the Prevention of Supine Sleep During Pregnancy: A Randomised Crossover Trial.BJOG : an international journal of obstetrics and gynaecology · 2025Trial
- Trial
- Trial
- Article
- A new frontier for positional therapy: obstetrics.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2025Article
- Sleeping posture in pregnancy.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2025Article
- Sleep conditions and sleep hygiene behaviors in early pregnancy are associated with gestational diabetes mellitus: A propensity-score matched study.Sleep & breathing = Schlaf & Atmung · 2024Article
- Vertigo During Pregnancy: A Narrative Review of the Etiology, Pathophysiology, and Treatment.Cureus · 2024Review
- Impact of maternal posture on fetal physiology in human pregnancy: a narrative review.Frontiers in physiology · 2024Review
- Vision-based detection and quantification of maternal sleeping position in the third trimester of pregnancy in the home setting-Building the dataset and model.PLOS digital health · 2023Article
- A Relation between Obstructive Sleep Apnea in Pregnancy and Delivering Small for Gestational Age Infant-A Systematic Review.Journal of clinical medicine · 2023Review
- Effects of maternal sleep position on fetal and maternal heart rate patterns using overnight home fetal ECG recordings.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2020Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo 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.
designA double-blind, randomised, sham-controlled, cross-over pilot trial.
settingConducted between March 2016 and January 2017, at a single, tertiary-level centre in Canada.
participants23 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/m
interventionsA 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.
resultsThe 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.
conclusionsThis 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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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.