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No-worry Baby Project

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ClinicalTrials.gov Identifier: NCT03922087
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Collaborator:
Huizhou First Maternal and Child Care Service Center
Information provided by (Responsible Party):
LIU ZHAOMIN, Sun Yat-sen University

Brief 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.

Condition or disease Intervention/treatment
Gestational Diabetes Mellitus in Pregnancy Gestational Hypertension Thyroid Disease Pregnancy Obesity Anemia in Pregnancy Complications, Pregnancy Depression Obstetric Labor Complications Asthma Allergic Disorder Immune System Diseases Neurodevelopmental Disorders Reproductive Disorder Other: No intervention

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Huizhou Mother-infant Cohort
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Control Group
The pregnancy women without any diseases.
Other: No intervention
No intervention

Disease Group
The pregnancy women with cardio-metabolic and endocrinic disorders such as gestational diabetes, obesity, hypertension, thyroid diseases, anemia and other cardio-metabolic diseases.
Other: No intervention
No intervention




Primary Outcome Measures :
  1. Number of adverse birth outcomes. [ Time Frame: At delivery. ]
    Including dystocia,stillbirth, fetal macrosomia and child with birth defect.

  2. Children weight changes. [ Time Frame: At age of 1 month, 3 months, 6months, 1 year, and 3 year. ]
    Weight is measured in kilograms.

  3. Children height changes. [ Time Frame: At age of 1 month, 3 months, 6months, 1 year, and 3 year. ]
    Height is measured in meters.

  4. Number of participant with gestational complications. [ Time Frame: At delivery. ]
    Including gestational hypertension and preeclampsia, and gestational diabetes mellitus.


Secondary Outcome Measures :
  1. Maternal weight changes(kg). [ Time Frame: At 20 weeks of gestation, 28 weeks of gestation, the time before labor and 30 days after delivery. ]
    Assess using electronic weighing machine and body composition analyzer.

  2. Number of participant with postnatal depression. [ Time Frame: At 30 days after delivery. ]
    Assess using Edinburgh Postnatal Depression Scale (EPDS). The total score of scale is 30 ,and higher score indicates worse status.


Biospecimen Retention:   Samples Without DNA
During pregnancy: maternal vein blood at mid- and last trimester, spot and 12-hr urine and feces at mid-trimester; At delivery: umbilical cord blood, placenta , umbilical cord, mother's milk. Postnatal: mother's vein blood During infancy: meconium. During childhood: Mother's milk and baby's feces.


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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Eligible pregnant women will be recruited from Huizhou First Maternal and Child Care Service Center.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03922087


Contacts
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Contact: Zhaomin Liu, Doctor 0086 20 87335562 liuzhm8@mail.sysu.edu.cn
Contact: Guoyi Li, Master 86 18129500664 ligy26@mail2.sysu.edu.cn

Locations
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China, Guangdong
School of Public Health of Sun Yat-sen University (North Campus) Recruiting
Guangzhou, Guangdong, China, 51000
Contact: Zhaomin Liu, Doctor    0086 20 87335562    liuzhm8@mail.sysu.edu.cn   
Sponsors and Collaborators
Sun Yat-sen University
Huizhou First Maternal and Child Care Service Center
Investigators
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Principal Investigator: Zhaomin Liu, Doctor School of Public Health of Sun Yat-sen University

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Responsible Party: LIU ZHAOMIN, Professor in Department of Nutrition and Food Hygiene, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03922087     History of Changes
Other Study ID Numbers: HZT2018
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes, Gestational
Hypertension, Pregnancy-Induced
Obstetric Labor Complications
Pregnancy in Diabetics
Pregnancy Complications
Thyroid Diseases
Hypersensitivity
Disease
Neurodevelopmental Disorders
Immune System Diseases
Pathologic Processes
Hypertension
Vascular Diseases
Cardiovascular Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Mental Disorders