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N/A N=23 Randomized Quadruple-blind Prevention

Halifax PrenaBelt Trial

Sleep · Pregnancy · Stillbirth · Infant, Low Birth Weight · Infant, Small for Gestational Age

Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Percentage (%) of Sleep Time Supine — 3.5; 16.4 percentage of sleep time (%)

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
PrenaBelt (Device); Sham PrenaBelt (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Allan Kember
Primary completion
Jan 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage (%) of Sleep Time Supine
3.5; 16.4
SECONDARY
Total Sleep Time
353; 350
SECONDARY
Supine Sleep Time
12.3; 56.8
SECONDARY
Left-lateral Sleep Time
185.6; 176.1
SECONDARY
Right-lateral Sleep Time
108.9; 101.9
SECONDARY
Percentage Sleep Left
57.0; 52.2
SECONDARY
Percentage Sleep Right
31.3; 29.3
SECONDARY
Sleep Latency
11.7; 14.5
SECONDARY
Sleep Efficiency
81; 83
SECONDARY
Total Arousal Index
11.2; 12.0
SECONDARY
Spontaneous Arousal Index
10.5; 10.3
SECONDARY
Periodic Limb Movement Arousal Index
0; 0.1
SECONDARY
Respiratory Arousal Index
0.4; 0.4
SECONDARY
Percent Stage 1 Sleep
9.1; 9.6
SECONDARY
Percent Stage 2 Sleep
64.5; 61.0
SECONDARY
Percent Stage 3 Sleep
10.9; 11.5
SECONDARY
Percent REM Sleep
15.5; 18.0
SECONDARY
Apnea Hypopnea Index
0.5; 0.5
SECONDARY
Respiratory Effort-Related Arousal Index
0; 0
SECONDARY
Respiratory Disturbance Index (RDI)
0.65; 0.55; 0; 0; 0.2; 0.5
SECONDARY
Peripheral Blood Oxygen Saturation (SpO2)
98; 98.5; 96; 96.3; 92.5; 92
SECONDARY
Number of Participants With Snoring
15; 11
SECONDARY
PrenaBelt User Feedback Questionnaire - Satisfaction
7.5; 7.5
SECONDARY
PrenaBelt User Feedback Questionnaire - Comfort
9.0; 9
SECONDARY
PrenaBelt User Feedback Questionnaire - Intention to Use
8; 7.0
SECONDARY
Sleep Onset Position
31; 29; 2; 3; 7; 8
SECONDARY
Waking Position
28; 22; 0; 5; 12; 13
SECONDARY
Number of Position Changes
3; 6
SECONDARY
Percentage of Total Sleep Time in Each Position
59.9; 54.4; 7.8; 14.8; 31.3; 30.8

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.

Eligibility Criteria

Inclusion Criteria

  • ≥18 years old
  • low-risk singleton pregnancy
  • in the last trimester of pregnancy (≥28 weeks of gestation)
  • residing in the Halifax Regional Municipality

Exclusion Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02377817). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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