Clinical trial NCT03922087: No-worry Baby Project
Official title: Huizhou Mother-infant Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Huizhou No.1 Maternal and Child Care Service Cencer
First posted: 2019-04-19
Enrollment: 5216
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eligible pregnant women will be recruited from Huizhou First Maternal and Child Care Service Center.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Number of adverse birth outcomes.
timeFrame: At delivery.
measure: Children weight changes.
timeFrame: At age of 1 month, 3 months, 6months, 1 year, and 3 year.
measure: Children height changes.
timeFrame: At age of 1 month, 3 months, 6months, 1 year, and 3 year.
measure: Number of participant with gestational complications.
timeFrame: At delivery.
Secondary outcomes:
measure: Maternal weight changes(kg).
timeFrame: At 20 weeks of gestation, 28 weeks of gestation, the time before labor and 30 days after delivery.
measure: Number of participant with postnatal depression.
timeFrame: At 30 days after delivery.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: School of Public Health of Sun Yat-sen University (North Campus)
state: Guangdong
Study officials:
affiliation: School of Public Health of Sun Yat-sen University
name: Zhaomin Liu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang D, Zhang S, Li G, Lai Y, Hao YT, Chen WQ, Wu Y, Chen C, Pan W, Liu ZM. A clinical model and nomogram for early prediction of gestational diabetes based on common maternal demographics and routine clinical parameters. J Obstet Gynaecol Res. 2022 Nov;48(11):2738-2747. doi: 10.1111/jog.15380. Epub 2022 Jul 31.