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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03099837
Other study ID # HuazhongU-2013-02
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 10, 2013
Est. completion date January 10, 2023

Study information

Verified date August 2020
Source Huazhong University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 8649
Est. completion date January 10, 2023
Est. primary completion date January 10, 2023
Accepts healthy volunteers
Gender Female
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Huazhong University of Science and Technology Maternal and Child Health Hospital of Hubei Province, The Central Hospital of Wuhan, Wuhan Maternal and Child Health Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Effect of weight gain during pregnancy on maternal and child health 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
Primary Effect of factors in pregnancy and early postpartum period on maternal health 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
Primary Influence of prenatal and early postnatal factors on child health 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
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