se of eye masks and earplugs compared with standard advice to improve sleep in pregnancy

Not Applicable

Completed

Conditions: ight sleep duration among sleep-deprived nulliparas and multiparas in their late third trimester
Pregnancy and Childbirth

Registration Number: ISRCTN19061849

Lead Sponsor: niversity Malaya Medical Centre

Brief Summary: 2023 Results article in https://doi.org/10.1093/sleep/zsad196 (added 24/06/2024)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 208

Inclusion Criteria

1. Nullipara (no prior pregnancy beyond 20 weeks gestation)
2. Multipara
3. 34 – 36 weeks of gestation
4. Self-reported sleep of fewer than 6 hours
5. Singleton pregnancy

Exclusion Criteria

1. Pre-existing sleep disorders: chronic insomnia, sleep apnea
2. Pre-existing psychiatric disorders: depression, schizophrenia etc
3. Pre-existing medical disorders: systemic lupus erythematosus, thyroid disorders, epilepsy, heart diseases etc.
4. Any ear/eye injury resulting in the participant not being able to wear the earplugs/eye-mask
5. Active smoker
6. Current alcohol consumption
7. Obesity >class II (body mass index >35)
8. Multipara with co-sleeping child/children
9. Night shift workers
10. Night care-taker of other family members
11. Gross fetal anomalies
12. Intrauterine fetal death

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ight sleep duration measured using the Actigraph wGT3X-BT device at the end of Week 1 (baseline) and Week 2 (intervention)

Secondary Outcome Measures

Name	Time	Method
1. Labour outcomes retrieved from patients’ records post-delivery:<br>1.1. Mode of delivery<br>1.2. Need for labour induction (mechanical induction, prostaglandin, amniotomy)<br>1.3. Peri-delivery blood loss<br>1.4. Epidural requirement<br>2. Neonatal outcomes retrieved from patients’ records post-delivery:<br>2.1. Birth weight<br>2.2. Cord pH and base excess<br>2.3. Apgar score at 5 minutes<br>2.4. Neonatal admission and indication<br>3. Subjects’ sleep satisfaction with the sleep aid measured using the Pittsburgh Sleep Quality Index (PSQI) during recruitment, and the modified Pittsburgh Sleep Quality Index at the end of Week 2 (after intervention)