A Cohort Study on Sleep Disorders During Pregnancy

Sleep Disorder Clinical Trial

Official title:

Sleep Trajectories Among Pregnant Women and Its Impact on Maternal and Infant Outcomes: a Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05765149
• Other study ID #: IRB-20220305-R
• Status: Recruiting
• Start date: February 17, 2023
• Est. completion date: February 2024

Study information

• Verified date: February 2023
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: Xiaoyan Yu, Master
• Phone: +86 13575737900
• Email: yuxy[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Parasomnias
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Other:
• No intervention
This is an observational study, no intervention will be implemented.

Locations

Country	Name	City	State
China	Women's Hospital School of Medicine Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Women's Hospital School Of Medicine Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preterm birth	Preterm birth refers to a body born before 37 weeks of gestation. It will be identified according to the medical history records.	delivery
Primary	Caesarean section	Caesarean section refers to a baby delivered through an incision in the mother's abdomen. It will be identified according to the medical history records.	delivery
Primary	Postpartum depression symptoms at 1 month after delivery	Postpartum depression symptoms at 1 month after delivery will be measured by the Edinburgh postpartum depression scale (EPDS).	1 month after delivery
Primary	Postpartum depression symptoms at 2 months after delivery	Postpartum depression symptoms at 2 months after delivery will be measured by the Edinburgh postpartum depression scale (EPDS).	2 months after delivery
Primary	Postpartum depression symptoms at 3 months after delivery	Postpartum depression symptoms at 3 months after delivery will be measured by the Edinburgh postpartum depression scale (EPDS).	3 months after delivery
Secondary	1-minute Apgar score	Apgar is a quick test performed on a baby at 1 and 5 minutes after birth. It will be identified according to the medical history records.	1 minute after delivey
Secondary	5-minute Apgar score	Apgar is a quick test performed on a baby at 1 and 5 minutes after birth. It will be identified according to the medical history records.	5 minutes after delivey
Secondary	Infant's length	It will be identified according to the medical history records.	delivey
Secondary	Infant's weight	It will be identified according to the medical history records.	delivey