- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03403543
Chinese Pregnant Woman Cohort Study
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.
Studieoversikt
Status
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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Beijing
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Beijing, Beijing, Kina, 100730
- Peking Union Medical College Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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.)
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
preterm birth
Tidsramme: 2017.10.1-2019.3.1
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The doctors will record the delivery time
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2017.10.1-2019.3.1
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birth weight
Tidsramme: 2017.10.1-2019.3.1
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The doctors will record the birth weight
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2017.10.1-2019.3.1
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birth defects
Tidsramme: 2017.10.1-2019.3.1
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The doctors will record the birth defects
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2017.10.1-2019.3.1
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Yu Jiang, doctor, School of Public Health, Chinese Academy of Medical Sciences and Peking Union Medical College
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- PUMC-CPWCS
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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