Trial reportBMJ open2019
The Ghana PrenaBelt trial: a double-blind, sham-controlled, randomised clinical trial to evaluate the effect of maternal positional therapy during third-trimester sleep on birth weight.
Trial report in BMJ open, 2019. 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 5 papers.
What it found
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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.
A Maternal Device to Reduce the Risk of Stillbirth and Low Birth-Weight
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
5 citing papers in PubMed.
- 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
- Effectiveness and acceptability of two insertable device models for non-surgical management of obstetric fistula: protocol for a hybrid type I randomized crossover trial.BMC women's health · 2025Article
- 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
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the effect, on birth weight and birth weight centile, of use of the PrenaBelt, a maternal positional therapy device, during sleep in the home setting throughout the third trimester of pregnancy.
designA double-blind, sham-controlled, randomised clinical trial.
settingConducted from September 2015 to May 2016, at a single, tertiary-level centre in Accra, Ghana.
participantsTwo-hundred participants entered the study. One-hundred-eighty-one participants completed the study. Participants were women, 18 to 35 years of age, with low-risk, singleton, pregnancies in their third-trimester, with body mass index <35 kg/m
interventionsParticipants were randomised by computer-generated, one-to-one, simple randomisation to receive either the PrenaBelt or sham-PrenaBelt. Participants were instructed to wear their assigned device to sleep every night for the remainder of their pregnancy (approximately 12 weeks in total) and were provided a sleep diary to track their use. Allocation concealment was by unmarked, security-tinted, sealed envelopes. Participants and the outcomes assessor were blinded to allocation. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcomes were birth weight and birth weight centile. Secondary outcomes included adherence to using the assigned device nightly, sleeping position, pregnancy outcomes and feedback from participants and maternity personnel.
resultsOne-hundred-sixty-seven participants were included in the primary analysis. The adherence to using the assigned device nightly was 56%. The mean ±SD birth weight in the PrenaBelt group (n=83) was 3191g±483 and in the sham-PrenaBelt group (n=84) was 3081g±484 (difference 110 g, 95% CI -38 to 258, p=0.14). The median (IQR) customised birth weight centile in the PrenaBelt group was 43% (18 to 67) and in the sham-PrenaBelt group was 31% (14 to 58) (difference 7%, 95% CI -2 to 17, p=0.11).
conclusionsThe PrenaBelt did not have a statistically significant effect on birth weight or birth weight centile in comparison to the sham-PrenaBelt. TRIAL REGISTRATION NUMBER: NCT02379728.
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Registered trials
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