A Cohort Study on Sleep Disorders During Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-17

Study Completion Date

2024-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Napping in Pregnant Women With Sleep Disturbances on Offspring Neurodevelopment

NCT06514833

Sleep

NOT_YET_RECRUITING NA

Sleep Health Care in Pregnancy: A Randomized Controlled Trial

NCT05694780

Pregnancy Related

RECRUITING NA

Effect of Clinical Insomnia and Sleep Deprivation on Maternal-fetal Outcome Among Egyptian Females in 3rd Trimester

NCT04612361

Effect of Insomnia and Sleep Deprivation in 3rdtrimester

UNKNOWN

Sleep Disordered Breathing, Endothelial Function, and Adverse Events in Pregnancy

NCT05908591

RECRUITING

Evaluation of Inpatient Sleep and Activity Following Childbirth

NCT05065203

Sleep

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sleep Cohort

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.

No intervention

Intervention Type OTHER

This is an observational study, no intervention will be implemented.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No intervention

This is an observational study, no intervention will be implemented.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes