Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tongji Maternal and Child Health Cohort (TMCHC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03099837
Recruitment Status : Active, not recruiting
First Posted : April 4, 2017
Last Update Posted : August 4, 2020
Sponsor:
Collaborators:
Maternal and Child Health Hospital of Hubei Province
The Central Hospital of Wuhan
Wuhan Maternal and Child Health Hospital
Information provided by (Responsible Party):
Nianhong Yang, Huazhong University of Science and Technology

Brief Summary:
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.

Condition or disease
Weight Gain Maternal; Diabetes Mellitus, Affecting Fetus Diet Habit Pregnancy Complications Birth Outcomes Breast Feeding Growth and Development

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 8649 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Maternal and Infant Health Survey
Actual Study Start Date : January 10, 2013
Estimated Primary Completion Date : January 10, 2023
Estimated Study Completion Date : January 10, 2023

Resource links provided by the National Library of Medicine


Group/Cohort
Pregnant mothers
infants
children



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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.
Criteria

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.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Nianhong Yang, Professor, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT03099837    
Other Study ID Numbers: HuazhongU-2013-02
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pregnancy Complications
Weight Gain
Body Weight Changes
Body Weight