Clinical Trials Directory

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UnknownNCT03403543

Chinese Pregnant Woman Cohort Study

Status
Unknown
Phase
Study type
Observational
Enrollment
5,000 (estimated)
Sponsor
Peking Union Medical College Hospital · Academic / Other
Sex
Female
Age
16 Years
Healthy volunteers
Accepted

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.

Conditions

Timeline

Start date
2017-07-01
Primary completion
2018-07-01
Completion
2019-12-01
First posted
2018-01-18
Last updated
2018-09-04

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT03403543. Inclusion in this directory is not an endorsement.