Skip to content

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05765149
Enrollment
1000
Registered
2023-03-13
Start date
2023-02-17
Completion date
2024-02-29
Last updated
2023-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Disorder

Brief 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.

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.

Interventions

OTHERNo intervention

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

Sponsors

Women's Hospital School Of Medicine Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Postpartum depression symptoms at 3 months after delivery3 months after deliveryPostpartum depression symptoms at 3 months after delivery will be measured by the Edinburgh postpartum depression scale (EPDS).
Preterm birthdeliveryPreterm birth refers to a body born before 37 weeks of gestation. It will be identified according to the medical history records.
Caesarean sectiondeliveryCaesarean section refers to a baby delivered through an incision in the mother's abdomen. It will be identified according to the medical history records.
Postpartum depression symptoms at 1 month after delivery1 month after deliveryPostpartum depression symptoms at 1 month after delivery will be measured by the Edinburgh postpartum depression scale (EPDS).
Postpartum depression symptoms at 2 months after delivery2 months after deliveryPostpartum depression symptoms at 2 months after delivery will be measured by the Edinburgh postpartum depression scale (EPDS).

Secondary

MeasureTime frameDescription
5-minute Apgar score5 minutes after deliveyApgar 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.
Infant's lengthdeliveyIt will be identified according to the medical history records.
Infant's weightdeliveyIt will be identified according to the medical history records.
1-minute Apgar score1 minute after deliveyApgar 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.

Countries

China

Contacts

Primary ContactXiaoyan Yu, Master
yuxy@zju.edu.cn+86 13575737900

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026