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NCT03403543 Clinical Trial

Chinese Pregnant Woman Cohort Study

Pregnancy Clinical Trial

Official title:
Chinese Pregnant Woman Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03403543
Other study ID # PUMC-CPWCS
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 1, 2017
Est. completion date December 1, 2019

Study information
Verified date August 2018
Source Peking Union Medical College Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 5000
Est. completion date December 1, 2019
Est. primary completion date July 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 16 Years and older
Eligibility The participants were pregnant women who satisfied the following criteria: (1) =16 years old; (2) at 5-12 weeks' gestational; (3) able to complete the questionnaire; (4) permanent residents in the study locations; and (5) willing to sign the consent form.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Peking Union Medical College Hospital Beijing Beijing

Sponsors (2)
Lead Sponsor Collaborator
Peking Union Medical College Hospital Peking Union Medical College

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary preterm birth The doctors will record the delivery time 2017.10.1-2019.3.1
Primary birth weight The doctors will record the birth weight 2017.10.1-2019.3.1
Primary birth defects The doctors will record the birth defects 2017.10.1-2019.3.1
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