Halifax PrenaBelt Trial
Modifying Maternal Sleep Position in the Third Trimester of Pregnancy With Positional Therapy: A Randomized Pilot Trial
1 other identifier
interventional
23
1 country
1
Brief Summary
Back and right-sided sleeping position in pregnant women has recently emerged as a potential risk factor for low birthweight (LBW) and stillbirth (SB) in the medical literature. Assuming that sleep position in pregnant women is modifiable, the same literature has indicated that this risk factor is modifiable; however, there is no evidence that this risk factor is truly modifiable. The proposed link between back and right-sided sleeping position in a pregnant woman and LBW and SB of her baby is multifactorial; however, it ultimately implicates the woman's body position in causing compression of one of the large veins that brings blood back to her heart. This compression, along with other factors relating to the woman, her placenta, and her developing fetus, may result in decreased blood flow (nutrition and oxygen) to her developing baby, which, depending on the extent and duration, could result in LBW or SB of her baby. If the back sleeping position during pregnancy has a causative role in LBW and subsequently SB, the literature indicates that up to 17% of LBW and consequently 26% of SB could potentially be prevented by changing position to avoid back sleep. Note that 20 million LBW and 2.6 million SB occur each year worldwide. Positional therapy (PT) is a safe and effective intervention for preventing people who snore or people who's breathing pauses during sleep from sleeping on their back - a position that makes their condition worse. The most basic form of PT modifies a person's sleeping position by either:
- Preventing them from sleeping on their back through restricting their movement, or
- Rather than restricting movement, significantly reducing the amount of time they spend sleeping on their back by applying pressure points to their body while they are on their back, which eventually causes them to shift into a different position and avoid lying on their back. The purpose of this study is to evaluate the ability of a PT intervention to modify the position of pregnant women from their back and right side to their left side while they sleep in late pregnancy. This study will help determine whether this potential risk factor is modifiable by way of a PT intervention, and whether it is feasible to intervene to reduce or prevent back and right-sided position sleep in late pregnancy. Demonstrating that the sleeping position of pregnant women can be modified through use of a simple, inexpensive PT intervention may be one of the keys to achieving significant reductions in LBW and late SB rates in Canada and worldwide.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2015
CompletedFirst Posted
Study publicly available on registry
March 4, 2015
CompletedStudy Start
First participant enrolled
March 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 28, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 28, 2017
CompletedResults Posted
Study results publicly available
April 2, 2020
CompletedApril 2, 2020
March 1, 2020
11 months
February 17, 2015
June 7, 2018
March 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage (%) of Sleep Time Supine
Proportion of sleeping time spent in the supine position
1 night (approximately 8 hours)
Secondary Outcomes (28)
Total Sleep Time
1 night (approximately 8 hours)
Supine Sleep Time
1 night (approximately 8 hours)
Left-lateral Sleep Time
1 night (approximately 8 hours)
Right-lateral Sleep Time
1 night (approximately 8 hours)
Percentage Sleep Left
1 night (approximately 8 hours)
- +23 more secondary outcomes
Study Arms (2)
PrenaBelt on First Sleep Test Night
EXPERIMENTALParticipants will be randomized to treatment order: sham PrenaBelt on first night, then PrenaBelt on second night, or vice versa. This will avoid the potential impact of changes to sleep across the two nights resulting from familiarization with the polysomnography equipment, which could bias the results.
Sham PrenaBelt on First Sleep Test Night
SHAM COMPARATORParticipants will be randomized to treatment order: sham PrenaBelt on first night, then PrenaBelt on second night, or vice versa. This will avoid the potential impact of changes to sleep across the two nights resulting from familiarization with the polysomnography equipment, which could bias the results.
Interventions
The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT. PT is a simple, non-invasive, inexpensive, long-established, safe, and effective intervention for preventing people with positional-dependent snoring or obstructive sleep apnea from sleeping on their back - a position that exacerbates their condition. The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back and right side of the user when she lies on her back or right side, respectively, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back or right side.
The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
Eligibility Criteria
You may qualify if:
- ≥18 years old
- low-risk singleton pregnancy
- in the last trimester of pregnancy (≥28 weeks of gestation)
- residing in the Halifax Regional Municipality
You may not qualify if:
- BMI ≥ 35 at booking (first antenatal appointment for current pregnancy)
- pregnancy complicated by obstetric complications (hypertension \[pre-eclampsia, gestational hypertension, chronic hypertension\], diabetes \[gestational or not\], or intra-uterine growth restriction \[\<10th %ile for growth\])
- sleep complicated by medical conditions (known obstructive sleep apnea, known to get \<4 hours of sleep per night due to insomnia, or musculoskeletal disorder that prevents sleeping on a certain side \[e.g., arthritic shoulder\])
- multiple pregnancy
- known fetal abnormality
- non-English speaking and reading
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allan Kemberlead
- Grand Challenges Canadacollaborator
- Innovative Canadians for Changecollaborator
- Global Innovations for Reproductive Health and Lifecollaborator
- Kaishin Chu Designcollaborator
- Nova Scotia Health Authoritycollaborator
- University of Michigancollaborator
- Harvard Universitycollaborator
Study Sites (1)
IWK Women's Health Centre
Halifax, Nova Scotia, B3K 6R8, Canada
Related Publications (7)
Owusu JT, Anderson FJ, Coleman J, Oppong S, Seffah JD, Aikins A, O'Brien LM. Association of maternal sleep practices with pre-eclampsia, low birth weight, and stillbirth among Ghanaian women. Int J Gynaecol Obstet. 2013 Jun;121(3):261-5. doi: 10.1016/j.ijgo.2013.01.013. Epub 2013 Mar 15.
PMID: 23507553BACKGROUNDStacey T, Thompson JM, Mitchell EA, Ekeroma AJ, Zuccollo JM, McCowan LM. Association between maternal sleep practices and risk of late stillbirth: a case-control study. BMJ. 2011 Jun 14;342:d3403. doi: 10.1136/bmj.d3403.
PMID: 21673002BACKGROUNDGordon A, Raynes-Greenow C, Bond D, Morris J, Rawlinson W, Jeffery H. Sleep position, fetal growth restriction, and late-pregnancy stillbirth: the Sydney stillbirth study. Obstet Gynecol. 2015 Feb;125(2):347-355. doi: 10.1097/AOG.0000000000000627.
PMID: 25568999BACKGROUNDPlatts J, Mitchell EA, Stacey T, Martin BL, Roberts D, McCowan L, Heazell AE. The Midland and North of England Stillbirth Study (MiNESS). BMC Pregnancy Childbirth. 2014 May 21;14:171. doi: 10.1186/1471-2393-14-171.
PMID: 24885461BACKGROUNDWarland J, Mitchell EA. A triple risk model for unexplained late stillbirth. BMC Pregnancy Childbirth. 2014 Apr 14;14:142. doi: 10.1186/1471-2393-14-142.
PMID: 24731396BACKGROUNDO'Brien LM, Warland J. Typical sleep positions in pregnant women. Early Hum Dev. 2014 Jun;90(6):315-7. doi: 10.1016/j.earlhumdev.2014.03.001. Epub 2014 Mar 21.
PMID: 24661447BACKGROUNDKember AJ, Scott HM, O'Brien LM, Borazjani A, Butler MB, Wells JH, Isaac A, Chu K, Coleman J, Morrison DL. Modifying maternal sleep position in the third trimester of pregnancy with positional therapy: a randomised pilot trial. BMJ Open. 2018 Aug 29;8(8):e020256. doi: 10.1136/bmjopen-2017-020256.
PMID: 30158217DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Performed in a controlled sleep laboratory setting over two nights; therefore, caution should be taken when extrapolating the results to the home setting and across the third trimester. Due to the small sample, may have been under-powered.
Results Point of Contact
- Title
- Dr. Allan Kember, Director of Programs
- Organization
- Global Innovations for Reproductive Health & Life
Study Officials
- PRINCIPAL INVESTIGATOR
Heather Scott, MD FRCSC
The IWK Health Centre
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Medical Student
Study Record Dates
First Submitted
February 17, 2015
First Posted
March 4, 2015
Study Start
March 15, 2016
Primary Completion
January 28, 2017
Study Completion
January 28, 2017
Last Updated
April 2, 2020
Results First Posted
April 2, 2020
Record last verified: 2020-03