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Chinese Pregnant Woman Cohort Study

NCT03403543 — Unknown, 5000 participants, Peking Union Medical College Hospital
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RegistryNCT03403543
StatusUnknown
Study typeObservational
Enrollment5000 (Estimated)
SponsorPeking Union Medical College Hospital (Other); collaborators: Peking Union Medical College
ConditionsPregnancy Related, Pregnancy Disease, Pregnancy, Infant, Risk Factor
Datesstart 2017-07-01, primary completion 2018-07-01, completion 2019-12-01 (estimated), first posted 2018-01-18, last updated 2018-09-04
Locations1 site in China

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
1This cohort study only set up a group. We will follow up and observe the pregnant women's lifestyle during pregnancy in order to find the risk factors of adverse pregnancy outcomes. We will divide the participants into more than one group according to the variables（e.g. age, smoking status, drinking status, sleep pattern .etc.）

+Outcome measures

Primary outcomes

  • preterm birth [2017.10.1-2019.3.1]: The doctors will record the delivery time
  • birth weight [2017.10.1-2019.3.1]: The doctors will record the birth weight
  • birth defects [2017.10.1-2019.3.1]: The doctors will record the birth defects

+Eligibility

Sex: Female, ages: 16 Years to any, accepts healthy volunteers

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.

+Locations (1)

FacilityCityCountryStatus
Peking Union Medical College HospitalBeijing, Beijing MunicipalityChina

+Publications

  • Results publication: Sun Y, Shen Z, Zhan Y, Wang Y, Ma S, Zhang S, Liu J, Wu S, Feng Y, Chen Y, Cai S, Shi Y, Ma L, Jiang Y. Investigation of optimal gestational weight gain based on the occurrence of adverse pregnancy outcomes for Chinese women: a prospective cohort study. Reprod Biol Endocrinol. 2021 Aug 30;19(1):130. doi: 10.1186/s12958-021-00797-y. PMID 34461936
  • Results publication: Lyu T, Chen Y, Zhan Y, Shi Y, Yue H, Liu X, Meng Y, Jing A, Qu Y, Ma H, Huang P, Man D, Li X, Wu H, Zhao J, Shan G, Jiang Y. Cohort profile: the Chinese Pregnant Women Cohort Study and Offspring Follow-up (CPWCSaOF). BMJ Open. 2021 Mar 23;11(3):e044933. doi: 10.1136/bmjopen-2020-044933. PMID 33757952
  • Results publication: Sun Y, Shen Z, Zhan Y, Wang Y, Ma S, Zhang S, Liu J, Wu S, Feng Y, Chen Y, Cai S, Shi Y, Ma L, Jiang Y. Effects of pre-pregnancy body mass index and gestational weight gain on maternal and infant complications. BMC Pregnancy Childbirth. 2020 Jul 6;20(1):390. doi: 10.1186/s12884-020-03071-y. PMID 32631269

+Investigators

  • Yu Jiang, doctor, Principal investigator, School of Public Health, Chinese Academy of Medical Sciences and Peking Union Medical College

My Notes