Trial reportBMC pregnancy and childbirth2023
Eye-masks and earplugs compared to headband in nulliparas on increasing spontaneous vaginal delivery: a randomized trial.
Trial report in BMC pregnancy and childbirth, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed, 0 citations in OpenAlex.
- Eye-mask and earplugs as sleep aid on glucose metabolism in sleep-deprived pregnancy: a randomized controlled trial.BMC pregnancy and childbirth · 2026Trial
Corrections and comments
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Authors and funding
5 authors at 2 institutions in 2 countries.
Funding
Abstract
backgroundA 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.
methodsThis 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.
resultsSpontaneous 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
conclusionEye-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 .
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