Clinical trial NCT03403543: Chinese Pregnant Woman Cohort Study
Official title: Chinese Pregnant Woman Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy Related
Pregnancy Disease
Pregnancy
Infant
Risk Factor
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College
First posted: 2018-01-18
Enrollment: 5000
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: preterm birth
timeFrame: 2017.10.1-2019.3.1
measure: birth weight
timeFrame: 2017.10.1-2019.3.1
measure: birth defects
timeFrame: 2017.10.1-2019.3.1
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: School of Public Health, Chinese Academy of Medical Sciences and Peking Union Medical College
name: Yu Jiang, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.