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Completed

NCT Number: NCT03922087

No-worry Baby Project

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.

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Key information

Conditions

Gestational Diabetes Mellitus in Pregnancy Allergic Disorder Anemia in Pregnancy Asthma Behavior Behavioral Symptoms Body Weight Bronchial Diseases Cardiovascular Diseases Complications, Pregnancy Depression Female Urogenital Diseases and Pregnancy Complications Gestational Hypertension Hypersensitivity Hypersensitivity, Immediate Hypertension Hypertension, Pregnancy-Induced Immune System Diseases Lung Diseases Lung Diseases, Obstructive Mental Disorders Neurodevelopmental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obstetric Labor Complications Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Complications Reproductive Disorder Respiratory Hypersensitivity Respiratory Tract Diseases Signs and Symptoms Thyroid Disease Pregnancy Urogenital Diseases Vascular Diseases

Age range

18 year–49 year

Sex eligibility

Female

Study type

Observational

Primary location

School of Public Health of Sun Yat-sen University (North Campus)

Guangzhou, Guangdong, 51000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Huizhou No.1 Maternal and Child Care Service Cencer

Registry information

Official study title

Huizhou Mother-infant Cohort

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Apr 19, 2019
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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