A Cohort Study on Sleep Disorders During Pregnancy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Disorder
• Intervention / Treatment: Other: No intervention

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Xiaoyan Yu, Master; Phone Number: +86 13575737900; Email: yuxy@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310029
      • Recruiting
      • Women's Hospital School of Medicine Zhejiang University
      • Contact: Man Wang; Phone Number: +86 15068826022; Email: wmdouble@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The study population is mainly from maternal hospitals.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: No intervention; This is an observational study, no intervention will be implemented.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Infant's length	It will be identified according to the medical history records.	delivey
Infant's weight	It will be identified according to the medical history records.	delivey

Collaborators and Investigators

• Sponsor: Women's Hospital School Of Medicine Zhejiang University
• Investigators: Principal Investigator: Man Wang, Master, Women's Hospital School of Medicine Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2023
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders; Parasomnias
• Other Study ID Numbers: IRB-20220305-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No