A trial of a new pillow to prevent sleeping on the back during pregnancy
- Conditions
- Sleep position in pregnancyfetal heart rate decelerations on fetal heart rate monitoringReproductive Health and Childbirth - Normal pregnancy
- Registration Number
- ACTRN12620000371998
- Lead Sponsor
- Institute for Breathing and Sleep
- Brief Summary
Background Self-reported going-to-sleep on the back during late pregnancy is related to an increase in stillbirth risk, possibly due to the enlarged uterus compressing major blood vessels supplying the placenta. This study aimed to test the effectiveness of a pillow designed to decrease supine sleep in pregnant women. Methods Thirty-five women in the third trimester of pregnancy used their own pillows for a control week and the intervention pillow for a week, in randomised order. Sleep position and total sleep time for each night of both weeks was monitored with the Night Shift Sleep Positioner, with a sleep study (WatchPat300) on the last night of each week to measure the impact of the intervention on sleep-disordered breathing. Results There was no difference in sleep time spent on the back overnight between the control or intervention pillow week, and hence no difference in the severity of sleep-disordered breathing across conditions. However, an increased percentage of back-sleeping overnight was significantly related to a higher degree of sleep-disordered breathing. Total sleep time was significantly longer while using the intervention pillow. Conclusion We found that the adoption of a pillow designed to discourage back sleeping was not effective in late pregnancy. Considering the reasonably high amount of back sleeping in our participants, alternative devices should be investigated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 42
Participants enrolled into the study will be low risk women with a singleton pregnancy in the third trimester (>28 weeks gestation) without known fetal abnormalities, who are aged 18 years or older, and capable of giving informed consent.
Known fetal abnormalities, aged 18 years or less, unable to give informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Percentage of total sleep time spent in the supine position, confirmed on sleep study position sensor and Night Shift position sensor[ Intervention and Control week - third trimester of pregnancy]
- Secondary Outcome Measures
Name Time Method Sleep quality as measured on WatchPAT300, including total sleep time, percentage of REM and slow wave sleep. This is a composite outcome.[ last night of intervention and control week - third trimester of pregnancy];subjective sleep quality as measured on a study specific questionnaire - sleep duration, rating of sleep quality from 1-10. This is a composite outcome.[ each night of intervention and control week - third trimester of pregnancy];sleep-disordered breathing indices as measured on WatchPAT300, including apnea/hypopnoea index and oxygen desaturation index[ Last night of intervention and control week - third trimester of pregnancy];fetal heart rate decelerations as measured on cardiotocography with the Monica AN24 (Monica Healthcare)[ Last night of intervention and control week - third trimester of pregnancy];Acceptability of the intervention pillow, as measured with a study specific questionnaire[ Each night of the intervention week - third trimester of pregnancy.]