NCT05765149

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

February 17, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

March 13, 2023

Status Verified

February 1, 2023

Enrollment Period

12 months

First QC Date

February 2, 2023

Last Update Submit

February 28, 2023

Conditions

Sleep Disorder

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (4)

  • 1-minute Apgar score

    1 minute after delivey

  • 5-minute Apgar score

    5 minutes after delivey

  • Infant's length

    delivey

  • Infant's weight

    delivey

Study Arms (1)

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

Interventions

No interventionOTHER

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

Sleep Cohort

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population is mainly from maternal hospitals.

You may qualify if:

  • Gestation age ≤ 13 weeks + 6 days
  • years old ≤ Age ≤ 40 years old
  • Singleton pregnancy
  • Give informed consent and able to participated

You may not qualify if:

  • Unmarried, divorced or widowed
  • Women who suffered severe physical or mental illness
  • Women who suffered death, abortion, stillbirth or neonatal death during the study
  • Women who are participating in other studies
  • Other reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, 310029, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Hair samples will be collected before delivery and 3 months after delivery.

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Man Wang, Master

    Women's Hospital School Of Medicine Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoyan Yu, Master

CONTACT

+86 13575737900yuxy@zju.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2023

First Posted

March 13, 2023

Study Start

February 17, 2023

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

March 13, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)