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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03922087
Other study ID # HZT2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 20, 2018
Est. completion date September 30, 2023

Study information

Verified date November 2023
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Huizhou mother-infant cohort was set up to investigate the effect of dietary factors and environmental exposures during pregnancy on health consequences of mothers and offsprings in Huizhou, China.


Description:

Huizhou mother-infant cohort (No-worry Baby Project) is a scientific research/public health project jointly initiated by Huizhou First Maternity and Child Healthcare Hospital and School of Public Health, Sun Yat-sen University. The project plans to recruit 10,000 participants since early pregnancy and follow up for three years after birth in the first stage. Biological samples, data from questionnaires survey and clinical information will be collected for both mothers and infants. The study is aimed to investigate the effects of dietary factors and environmental exposures during pregnancy on infants' health as well as the prognosis of diseased mothers. The study will have essentially both clinical and public health implications to find effective strategies for prevention and management of a range of chronic disorders (above mentioned) during pregnancy and exploration of the possible impacts on offspring health. The cohort will provide scientific basic for improvement of mother and infant's health.


Recruitment information / eligibility

Status Completed
Enrollment 5216
Est. completion date September 30, 2023
Est. primary completion date April 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 49 Years
Eligibility Inclusion Criteria: - Pregnant women who have plan to delivery and participate in child care in Huizhou hospital; - Pregnant women who have resided in Huizhou for at least 3 years; - Pregnant women who are consent for specimens and data collection and follow-ups for both mother and infant. Exclusion Criteria: - Pregnant women who are with gestational age more than 24 weeks ; - Pregnant women who refuse to participate or be unwilling to sign informed consent; - Pregnant women who are mentally incapacitated and need guardians.

Study Design


Intervention

Other:
No intervention
No intervention

Locations

Country Name City State
China School of Public Health of Sun Yat-sen University (North Campus) Guangzhou Guangdong

Sponsors (2)

Lead Sponsor Collaborator
Sun Yat-sen University Huizhou No.1 Maternal and Child Care Service Cencer

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of adverse birth outcomes. Including dystocia,stillbirth, fetal macrosomia and child with birth defect. At delivery.
Primary Children weight changes. Weight is measured in kilograms. At age of 1 month, 3 months, 6months, 1 year, and 3 year.
Primary Children height changes. Height is measured in meters. At age of 1 month, 3 months, 6months, 1 year, and 3 year.
Primary Number of participant with gestational complications. Including gestational hypertension and preeclampsia, and gestational diabetes mellitus. At delivery.
Secondary Maternal weight changes(kg). Assess using electronic weighing machine and body composition analyzer. At 20 weeks of gestation, 28 weeks of gestation, the time before labor and 30 days after delivery.
Secondary Number of participant with postnatal depression. Assess using Edinburgh Postnatal Depression Scale (EPDS). The total score of scale is 30 ,and higher score indicates worse status. At 30 days after delivery.
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