- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03099837
Tongji Maternal and Child Health Cohort (TMCHC)
August 1, 2020 updated by: Nianhong Yang, Huazhong University of Science and Technology
Maternal and Infant Health Survey
This is a population-based study to obtain data for the evaluation of current used recommendations for weight gain during pregnancy released by IOM (2007) and investigate the association between maternal diet and the health outcomes of mother and offspring.
Study Overview
Status
Unknown
Detailed Description
This is an ongoing population-based prospective cohort study to obtain data for the evaluation of current used recommendations for weight gain during pregnancy released by IOM (2007) and investigate the association between maternal diet and the health outcomes of mother and offspring.
8649 pregnant have been recuited from the first trimester of pregnancy.
All datas including the general information, sociodemographic facts, physical exam (body weight, height, blood pressure, etc), laboratory test (hemoglobin, glucose concentration, etc.) and dietary survey (FFQ, 24h food recall) have been collected during the cohort study.
Blood sample leftover from the clinical use are remained and stored at -80℃for further measurements.
Obstetric characteristics, maternal and perinatal outcomes have been observed and recorded.
Growth and development paremeters such as weight, length and head circumference as well as disease information of infants have been collected , feeding pattern and feeding history will be surveyed.
All data collected will be used for group analysis only and all private and individual records will be kept secret.
Study Type
Observational
Enrollment (Actual)
8649
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
The Tongji Maternal and Child Health enrolled healthy pregnant women at 8-16 weeks gestation when they attended their first antenatal visit at a maternity clinic in one of these following hospitals in Wuhan, China: Hubei Maternal and Child Health Hospital (HMCHH), The Central Hospital of Wuhan(CHW), Wuhan Maternal and Child Health Hospital (WMCHH), Jiang'an Maternal and Child Health Hospital(JMCHH).
Babies born from these mothers will be followed up until the child is at least 10 years of age.
Description
Inclusion Criteria:
- Pregnant women attending the first visit (<16 weeks ) at at a maternity clinic in one of these following hospitals in Wuhan, China: HMCHH, CHW,WMCHH,JMCHH.
Intention to visit the maternity clinic regularly in HMCHH or CHW or WMCHH or JMCHH.
- Intention to eventually deliver in HMCHH or CHW or WMCHH.
- The pregnant woman and her husband are Chinese.
Exclusion Criteria:
- Pregnant women on chemotherapy.
- Exclude women on certain medications - e.g. psychotropic drugs.
- Exclude women with significant medical conditions e.g. psychosis etc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
children
|
|
Pregnant mothers
|
|
infants
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of weight gain during pregnancy on maternal and child health
Time Frame: During pregnancy, infancy period and childhood, assessed up to 120 months
|
To regularly measure the weight gains of pregnant women during pregnancy, and examine their association with maternal and child health.
|
During pregnancy, infancy period and childhood, assessed up to 120 months
|
|
Effect of factors in pregnancy and early postpartum period on maternal health
Time Frame: During pregnancy and postpartum period, assessed up to 12 months
|
To examine the role of maternal nutrition, lifestyle, emotional health, and other environmental factors in pregnancy or postpartum period that can influence future maternal risk of metabolic disorders and even lead to complications of pregnancy, such as gestational diabetes mellitus.
|
During pregnancy and postpartum period, assessed up to 12 months
|
|
Influence of prenatal and early postnatal factors on child health
Time Frame: During pregnancy, infancy period and childhood, assessed up to 120 months
|
To examine the role of maternal nutrition, lifestyle, emotional health, breastfeeding, and other environmental factors in infancy that can influence the development of phenotypes in childhood which confer risk for later metabolic and mental disorders.
|
During pregnancy, infancy period and childhood, assessed up to 120 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Zhong C, Xiong G, Lin L, Li Q, Chen X, Zhang X, Zhang Y, Xu S, Wang X, Gao D, Wu M, Yang S, Han W, Sun G, Yang X, Hao L, Jin Z, Yang N. The association of maternal vaginal bleeding and progesterone supplementation in early pregnancy with offspring outcomes: a prospective cohort study. BMC Pregnancy Childbirth. 2022 May 5;22(1):390. doi: 10.1186/s12884-022-04711-1.
- Li Y, Zhou X, Zhang Y, Zhong C, Huang L, Chen X, Chen R, Wu J, Li Q, Sun G, Yin H, Xiong G, Hao L, Yang N, Yang X. Association of Maternal Dietary Patterns With Birth Weight and the Mediation of Gestational Weight Gain: A Prospective Birth Cohort. Front Nutr. 2021 Nov 26;8:782011. doi: 10.3389/fnut.2021.782011. eCollection 2021.
- Xiong T, Wu Y, Huang L, Chen X, Zhang Y, Zhong C, Gao Q, Hong M, Hu X, Yang X, Yang N, Hao L. Association of the maternal serum albumin level with fetal growth and fetal growth restriction in term-born singletons: a prospective cohort study. Fertil Steril. 2022 Feb;117(2):368-375. doi: 10.1016/j.fertnstert.2021.09.016. Epub 2021 Oct 20.
- Gao Q, Zhong C, Zhou X, Chen R, Xiong T, Hong M, Li Q, Kong M, Xiong G, Han W, Sun G, Yang X, Yang N, Hao L. Inverse association of total polyphenols and flavonoids intake and the intake from fruits with the risk of gestational diabetes mellitus: A prospective cohort study. Clin Nutr. 2021 Feb;40(2):550-559. doi: 10.1016/j.clnu.2020.05.053. Epub 2020 Jun 13.
- Zhou X, Chen R, Zhong C, Wu J, Li X, Li Q, Cui W, Yi N, Xiao M, Yin H, Xiong G, Han W, Hao L, Yang X, Yang N. Fresh fruit intake in pregnancy and association with gestational diabetes mellitus: A prospective cohort study. Nutrition. 2019 Apr;60:129-135. doi: 10.1016/j.nut.2018.09.022. Epub 2018 Oct 24.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 10, 2013
Primary Completion (ANTICIPATED)
January 10, 2023
Study Completion (ANTICIPATED)
January 10, 2023
Study Registration Dates
First Submitted
March 17, 2017
First Submitted That Met QC Criteria
March 28, 2017
First Posted (ACTUAL)
April 4, 2017
Study Record Updates
Last Update Posted (ACTUAL)
August 4, 2020
Last Update Submitted That Met QC Criteria
August 1, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HuazhongU-2013-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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