A Cohort Study on Sleep Disorders During Pregnancy

Women's Hospital School Of Medicine Zhejiang University

Status: Enrolling

Conditions: Sleep Disorder

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05765149

IRB-20220305-R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Gestation age ≤ 13 weeks + 6 days
2. 20 years old ≤ Age ≤ 40 years old
3. Singleton pregnancy
4. Give informed consent and able to participated

Exclusion criteria

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

Trial design

1,000 participants in 1 patient group

Sleep Cohort

Description:

This is an observational study. We plan to recruit 1000 pregnant women during 10-13 weeks gestational age to build a sleep cohort. Their sleep changes during pregnancy will be recorded for identifying similar groups.

Treatment:

Other: No intervention