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Clinical Trials/NCT03403543
NCT03403543
Unknown
Not Applicable

Chinese Pregnant Woman Cohort Study

Peking Union Medical College Hospital1 site in 1 country5,000 target enrollmentJuly 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy Related
Sponsor
Peking Union Medical College Hospital
Enrollment
5000
Locations
1
Primary Endpoint
preterm birth
Last Updated
7 years ago

Overview

Brief Summary

Purpose To determine the relationship between maternal lifestyle and obstetric and neonatal outcomes.

Methods and analysis This is a multicentre, prospective, cohort study including more than 5000 participants in 24 hospitals in 12 provinces from July 2017 to July 2018 in China. Maternal lifestyle (environmental exposures, diet, physical activity, sleeping, psychology and economics) and metabolic status will be collected by the electronic self-administered questionnaire at the first, second and third trimesters and 42 days postpartum, respectively. Obstetric and neonatal outcomes and metabolic status recorded by a clinical research coordinator. Descriptive statistics will be used to investigate the outcomes of maternal and newborn across China. Logistical regression and covariance analysis will be used to determine the relationship between maternal lifestyle and obstetric and neonatal outcomes. SAS statistical software will be used for data analysis.

Ethics and dissemination Permission for the study was obtained from Chinese Academy of Medical Sciences and Peking Union Medical College. Ethics approval was obtained from the Ethics Review Committee at Department of Scientific Research, Peking Union Medical College Hospital, Beijing, China. The results will be published in peer-reviewed journals or disseminated through conference presentations.

Registry
clinicaltrials.gov
Start Date
July 1, 2017
End Date
December 1, 2019
Last Updated
7 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Liangkun Ma

Obstetrics and Gynecology

Peking Union Medical College Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

preterm birth

Time Frame: 2017.10.1-2019.3.1

The doctors will record the delivery time

birth weight

Time Frame: 2017.10.1-2019.3.1

The doctors will record the birth weight

birth defects

Time Frame: 2017.10.1-2019.3.1

The doctors will record the birth defects

Study Sites (1)

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