Pregnancy Clinical Trial
Official title:
Modifying Maternal Sleep Position in the Third Trimester of Pregnancy With Positional Therapy: A Randomized Pilot Trial
Verified date | March 2020 |
Source | IWK Health Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 23 |
Est. completion date | January 28, 2017 |
Est. primary completion date | January 28, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | IWK Women's Health Centre | Halifax | Nova Scotia |
Lead Sponsor | Collaborator |
---|---|
Allan Kember | Global Innovations for Reproductive Health and Life, Grand Challenges Canada, Harvard University, Innovative Canadians for Change, Kaishin Chu Design, Nova Scotia Health Authority, University of Michigan |
Canada,
Gordon 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):347-55. doi: 10.1097/AOG.0000000000000627. — View Citation
O'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. — View Citation
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. — View Citation
Platts 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. — View Citation
Stacey 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. — View Citation
Warland 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage (%) of Sleep Time Supine | Proportion of sleeping time spent in the supine position | 1 night (approximately 8 hours) | |
Secondary | Total Sleep Time | This is a standard polysomnography measure of the amount of time the participant spent sleeping during the sleep test. | 1 night (approximately 8 hours) | |
Secondary | Supine Sleep Time | The time (in minutes) spent sleeping in the supine position. | 1 night (approximately 8 hours) | |
Secondary | Left-lateral Sleep Time | Time (in minutes) spent sleeping in the left-lateral position. | 1 night (approximately 8 hours) | |
Secondary | Right-lateral Sleep Time | Time (in minutes) spent sleeping in the right-lateral position. | 1 night (approximately 8 hours) | |
Secondary | Percentage Sleep Left | Percentage (%) of sleeping time in the left-lateral position. | 1 night (approximately 8 hours) | |
Secondary | Percentage Sleep Right | Percentage (%) of sleeping time in the right-lateral position. | 1 night (approximately 8 hours) | |
Secondary | Sleep Latency | This is a standard polysomnography measure of the amount of time (in minutes) that it takes a participant to transition from full wakefulness to sleep. | 1 night (approximately 8 hours) | |
Secondary | Sleep Efficiency | This is a standard polysomnography measure of the percentage (%) of time the participant was asleep during the sleep test. | 1 night (approximately 8 hours) | |
Secondary | Total Arousal Index | This is a standard polysomnography measure of the number of times the participant was aroused from a deeper stage of NREM sleep to a lighter stage, or from REM sleep toward wakefulness. This is reported as a 'total arousal index', which is an average of the number of arousals per hour, and is further classified as a spontaneous, periodic leg movement, or respiratory arousal index. | 1 night (approximately 8 hours) | |
Secondary | Spontaneous Arousal Index | This is a standard polysomnography measure of the number of times the participant was spontaneously aroused from a deeper stage of NREM sleep to a lighter stage, or from REM sleep toward wakefulness. This is reported as an 'arousal index', which is an average of the number of arousals per hour. | 1 night (approximately 8 hours) | |
Secondary | Periodic Limb Movement Arousal Index | This is a standard polysomnography measure of the number of times the participant was aroused from a deeper stage of NREM sleep to a lighter stage, or from REM sleep toward wakefulness due to periodic limb movements (PLMs). This is reported as an 'arousal index', which is an average of the number of arousals per hour. | 1 night (approximately 8 hours) | |
Secondary | Respiratory Arousal Index | This is a standard polysomnography measure of the number of times the participant was aroused from a deeper stage of NREM sleep to a lighter stage, or from REM sleep toward wakefulness due to respiratory events. This is reported as an 'arousal index', which is an average of the number of arousals per hour. | 1 night (approximately 8 hours) | |
Secondary | Percent Stage 1 Sleep | Percent (%) of total sleep time in sleep stage 1. | 1 night (approximately 8 hours) | |
Secondary | Percent Stage 2 Sleep | Percent (%) of total sleep time in sleep stage 2. | 1 night (approximately 8 hours) | |
Secondary | Percent Stage 3 Sleep | Percent (%) of total sleep time in sleep stage 3. | 1 night (approximately 8 hours) | |
Secondary | Percent REM Sleep | Percent (%) of total sleep time in rapid eye movement (REM) sleep | 1 night (approximately 8 hours) | |
Secondary | Apnea Hypopnea Index | Apnea hypopnea index (AHI) is a standard polysomnography measure to indicate the severity of sleep apnea. AHI is the average number of apnea and hypopnea events per hour. Will be reported as a total AHI in units of 'events per hour'. | 1 night (approximately 8 hours) | |
Secondary | Respiratory Effort-Related Arousal Index | Respiratory Effort-Related Arousal (RERA) index is a standard polysomnography measure to indicate arousals from respiratory effort. Will be reported in units of 'arousals per hour'. | 1 night (approximately 8 hours) | |
Secondary | Respiratory Disturbance Index (RDI) | This is a standard polysomnography measure. Like the AHI, RDI reports on respiratory events during sleep, but unlike the AHI, it also includes respiratory-effort related arousals (RERAs). RERAs are arousals from sleep that do not technically meet the definitions of apneas or hypopneas, but do disrupt sleep. Will be reported as a total RDI as well as RDI while supine and RDI while non-supine. | 1 night (approximately 8 hours) | |
Secondary | Peripheral Blood Oxygen Saturation (SpO2) | SpO2 measured by fingertip pulse oximetry is a standard measure to indicate the oxygen saturation. Mean SpO2, Min SpO2, and Max SpO2 during Rapid Eye Movement (REM), and Non-REM (NREM) states. | 1 night (approximately 8 hours) | |
Secondary | Number of Participants With Snoring | This is a standard polysomnography measure of the presence of snoring via nasal cannula (pressure transducer) and by objective report of the research assistant (real-time audio feed). | 1 night (approximately 8 hours) | |
Secondary | PrenaBelt User Feedback Questionnaire - Satisfaction | Each participant will complete the PrenaBelt User Feedback Questionnaire. On a scale of 1 to 10, participant's level of satisfaction with the PrenaBelt. Note: 1 = extremely dissatisfied 5-6 = acceptable 10 = extremely satisfied |
1 night (approximately 8 hours) | |
Secondary | PrenaBelt User Feedback Questionnaire - Comfort | Each participant will complete the PrenaBelt User Feedback Questionnaire. On a scale of 1 to 10, participant's level of comfort while wearing and sleeping with the PrenaBelt. Note: 1 = extremely uncomfortable 5-6 = acceptable 10 = extremely comfortable |
1 night (approximately 8 hours) | |
Secondary | PrenaBelt User Feedback Questionnaire - Intention to Use | Each participant will complete the PrenaBelt User Feedback Questionnaire. On a scale of 1 to 10, participant's intention to use the PrenaBelt during a subsequent pregnancy if it was available to her. Note: 1 = participant would never use it again 5-6 = participant would consider using it again 10 = participant would certainly use it again |
1 night (approximately 8 hours) | |
Secondary | Sleep Onset Position | To determine the accuracy of self-reported sleep behaviours against the gold-standard, polysomnography. This is the sleep onset position (left, supine, right) per the participant's self report and is compared with the sleep onset position (left, supine, right) per the polysomnography data. | 1 night (approximately 8 hours) | |
Secondary | Waking Position | To determine the accuracy of self-reported sleep behaviours against the gold-standard, polysomnography. This is the participant's waking position (left, supine, right, prone) per the participant's self report and is compared with the waking position (left, supine, right, prone) per the polysomnography data. | 1 night (approximately 8 hours) | |
Secondary | Number of Position Changes | To determine the accuracy of self-reported sleep behaviours against the gold-standard, polysomnography. This is the number of times the participant changed body position (e.g., supine to left side) per the participant's self report and is compared with the number of times the participant changed body position per the polysomnography data. | 1 night (approximately 8 hours) | |
Secondary | Percentage of Total Sleep Time in Each Position | To determine the accuracy of self-reported sleep behaviours against the gold-standard, polysomnography. This is the percentage (%) of total sleep time in each position (left, supine, right, prone) per the participant's self report and is compared with the percentage (%) of total sleep time in each position (left, supine, right, prone) per the polysomnography data. | 1 night (approximately 8 hours) |
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