Chinese Pregnant Woman Cohort Study

NCT03403543 | Unknown DMC

• 1 other identifier: PUMC-CPWCS
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Pregnancy Disease; Pregnancy; Infant; Risk Factor

Outcome Measures

Primary Outcomes (3)

• preterm birth

  The doctors will record the delivery time

  2017.10.1-2019.3.1

• birth weight

  The doctors will record the birth weight

  2017.10.1-2019.3.1

• birth defects

  The doctors will record the birth defects

  2017.10.1-2019.3.1

Study Arms (1)

1

This 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.）

Eligibility Criteria

• Age: 16 Years+
• Gender Eligibility Details: only pregnant women at 5-12weeks gestationnal will be included in this study
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

More than 5000 pregnant women will be recruited from July 2017 to July 2018 during their routine antenatal check at the first trimester. Maternal lifestyle (environmental exposure, diet, nutrient, physical activity, sleep quality, psychology and economics) are collected by electronic self-administered questionnaire at the first, second, third and 42 days postpartum. A clinical research coordinator will record the metabolic status (pre-pregnancy BMI and GWG) and obstetric and neonatal outcomes will be recorded.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Peking Union Medical College: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (3)

• 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 DERIVED

• 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 DERIVED

• 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 DERIVED

Study Officials

• Yu Jiang, doctor

  School of Public Health, Chinese Academy of Medical Sciences and Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Obstetrics and Gynecology

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 18, 2018
• Study Start: July 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: December 1, 2019
• Last Updated: September 4, 2018

Record last verified: 2018-08

Locations

CN (1)