Trials / Unknown
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.