Department of Obstetrics and Gynecology, Faculty of Medicine, Universiti Malaya, Jalan Profesor Diraja Ungku Aziz, 50603, Kuala Lumpur, Malaysia.
Trinity College Dublin, University of Dublin, Dublin 2, College Green, D02 PN40, Ireland.
BMC Pregnancy Childbirth. 2023 May 24;23(1):378. doi: 10.1186/s12884-023-05685-4.
A majority of pregnant women experience sleep disruption during pregnancy, especially in the third trimester. Lack of sleep is associated with preterm birth, prolonged labor and higher cesarean section rate. Six or less hours of night sleep in the last month of pregnancy is associated with a higher rate of caesarean births. Eye-masks and earplugs compared to headband improve night sleep by 30 or more minutes. We sought to evaluate eye-mask and earplugs compared to sham/placebo headbands on spontaneous vaginal delivery.
This randomized trial was conducted from December 2019-June 2020. 234 nulliparas, 34-36 weeks' gestation with self-reported night sleep < 6 h were randomized to eye-mask and earplugs or sham/placebo headband (both characterized as sleep aids) to be worn each night to delivery. After two weeks, interim outcome data of the average night sleep duration and the trial sleep related questionnaire was answered through the telephone.
Spontaneous vaginal delivery rates were 60/117(51.3%) vs. 52/117(44.4%) RR 1.15 95% CI 0.88-1.51 P = 0.30 for eye-mask and earplugs or headband respectively. At 2-weeks into the intervention period, the eye-mask and earplugs arm reported longer night sleep duration 7.0 ± 1.2 vs. 6.6 ± 1.5 h P = 0.04, expressed increased satisfaction with the allocated aid 7[6.0-8.0] vs. 6[5.0-7.5] P < 0.001, agreed they slept better 87/117(74.4%) vs. 48/117(41.0%) RR 1.81 95% CI 1.42-2.30 NNT 4 (2.2-4.7) P < 0.001 and higher compliance median[interquartile range] 5[3-7] vs. 4[ 2-5] times per week of sleep aid use P = 0.002.
Eye-mask and earplugs use at home in late third trimester do not increase the spontaneous vaginal delivery rate even though self-reported night sleep duration, sleep quality, satisfaction and compliance with allocated sleep aid were significantly better than for sham/placebo headband. Trial registration This trial was registered with ISRCTN on June 11, 2019 with trial identification number: ISRCTN99834087 .
大多数孕妇在怀孕期间会出现睡眠中断，尤其是在孕晚期。睡眠不足与早产、产程延长和剖宫产率升高有关。在妊娠最后一个月，每晚睡眠时间少于 6 小时与更高的剖宫产率有关。眼罩和耳塞与头带相比，可将夜间睡眠时间延长 30 分钟或更长时间。我们旨在评估眼罩和耳塞与假/安慰剂头带在自然分娩方面的效果。
这是一项于 2019 年 12 月至 2020 年 6 月进行的随机试验。纳入了 234 名初产妇，孕周为 34-36 周，自我报告夜间睡眠时间<6 小时，将她们随机分为眼罩和耳塞组或假/安慰剂头带组（均被归类为助眠工具），每晚佩戴至分娩。两周后，通过电话回答平均夜间睡眠时间和试验睡眠相关问卷的中期结果数据。
自然分娩率分别为 60/117（51.3%）和 52/117（44.4%），眼罩和耳塞组与头带组的 RR 为 1.15，95%CI 为 0.88-1.51，P=0.30。在干预期的两周内，眼罩和耳塞组报告的夜间睡眠时间更长，为 7.0±1.2 小时，而头带组为 6.6±1.5 小时，P=0.04。对分配的辅助工具的满意度更高，眼罩和耳塞组为 7[6.0-8.0]，而头带组为 6[5.0-7.5]，P<0.001。报告睡眠质量更好的比例更高，眼罩和耳塞组为 87/117（74.4%），而头带组为 48/117（41.0%），RR 为 1.81，95%CI 为 1.42-2.30，NNT 为 4（2.2-4.7），P<0.001。眼罩和耳塞组的每周使用助眠工具的依从性中位数[四分位间距]为 5[3-7]次，而头带组为 4[2-5]次，P=0.002。
尽管自我报告的夜间睡眠时间、睡眠质量、对分配的助眠工具的满意度和使用依从性均明显优于假/安慰剂头带，但在孕晚期使用家庭用的眼罩和耳塞并不能提高自然分娩率。
该试验于 2019 年 6 月 11 日在 ISRCTN 注册，试验编号为 ISRCTN99834087。
