A Cohort Study on Sleep Disorders During Pregnancy

Phase

N/A

Condition

Insomnia

Sleep Disorders

Restless Leg Syndrome

Treatment

N/A

Clinical Study ID

NCT05765149

IRB-20220305-R

Ages 20-40
Female
Accepts Healthy Volunteers

Study Summary

The goal of this observational study is to: 1) determine the prevalence of sleep disorders in pregnancy and the early postpartum; 2) identify factors associated with sleep disturbance during pregnancy and the early postpartum; 3) describe the progression of sleep quality and quantity as gestational age; 4) determine if sleep is associated with adverse perinatal outcomes. Participants were asked to wear a forehead sleep recorder for 4 consecutive days and to complete a sleep questionnaire at ten timepoints: at 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, and 9 months pregnant and at 1 month, 2 months and 3 months postpartum.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Gestation age ≤ 13 weeks + 6 days
20 years old ≤ Age ≤ 40 years old
Singleton pregnancy
Give informed consent and able to participated

Exclusion

Exclusion Criteria:

Unmarried, divorced or widowed
Women who suffered severe physical or mental illness
Women who suffered death, abortion, stillbirth or neonatal death during the study
Women who are participating in other studies
Other reasons

Study Design

February 17, 2023

February 29, 2024

Study Description

There is a high incidence of sleep disturbances globally, especially among pregnant women. Long-term sleep disorders seriously affect the quality life of individuals, and it becomes undoubtedly an important public health problem. Studies have shown that sleep disorders during pregnancy can have short-term and long-term adverse effects on both mothers and their babies. In addition, sleep during pregnancy exhibits different characteristics at different stages. Most of the existing studies are based on the overall development trend to study sleep characteristics, ignoring potential individual differences. Based on the concept of precision medicine, this study intends to establish a cohort focusing on the sleep health of pregnant women, and carry out continuous home sleep monitoring of pregnant women from both subjective and objective perspectives. The aim of this study is, firstly, to explore the longitudinal change characteristics, potential classification and influencing factors of sleep during pregnancy; secondly, to analyze the differences in maternal and infant adverse outcomes among pregnant women with different sleep development trajectories. The final goal is to reveal the exposure window of maternal and infant adverse outcomes caused by sleep, thus improving the accuracy of outcome prediction, and promoting the development of accurate and personalized sleep management programs.

Connect with a study center

Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang 310029
China
Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.