NCT03215368

Brief Summary

The Ma'anshan Birth Cohort (MABC) is a population-based prospective pregnancy and birth cohort study that aims to explore the early environmental and genetic determinants of maternal and child health, with a focus on health outcomes including maternal health, children's cognitive and behavioral development, growth and physical development, video-screen behaviors, and asthma and allergic diseases. MABC was officially launched in May 2013 at the Ma'anshan Maternal and Child Health Hospital in Anhui Province, and a total of 3,474 families were recruited as of September 2014 to continuously track the health status of mother-child pairs during pregnancy, delivery, and childhood, including basic family demographics, maternal pregnancy and birth history and past history, history of exposure to hazardous factors during pregnancy, children's diets and lifestyles, and children's physical and cognitive-behavioral development, MABC quantifies the attributional relationship between environmental chemicals, diet and nutrition, drug safety, psychological stress, lifestyle, biorhythm, endocrine metabolism and adverse birth outcomes, birth defects, neurodevelopmental disorders, developmental disabilities, etc., and identifies environmental, behavioral and genetic causative factors for birth defects and common developmental disorders, and identifies early warning signs and symptoms for early detection of birth defects. genetic causative factors, identify clinical biomarkers with early predictive effects, integrate and form a precise risk evaluation and early warning model, carry out regional comprehensive prevention and treatment applications, and promote the improvement of the quality of the birth population. Currently, MABC is conducting its 20th school-age follow-up visit.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,474

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started May 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
May 2013Dec 2027

Study Start

First participant enrolled

May 16, 2013

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 12, 2017

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

April 12, 2024

Status Verified

April 1, 2024

Enrollment Period

14.6 years

First QC Date

July 6, 2017

Last Update Submit

April 10, 2024

Conditions

Keywords

birth cohort studyenvironmental exposuresbirth defectspregnant outcomeschildren developmentMaternal and child health

Outcome Measures

Primary Outcomes (2)

  • Numbers of participants with pregnancy complications

    Including gestational diabetes, gestational hypertension, anemia, and hypothyroidism during pregnancy. Diagnosis by medical personnel at clinics

    At delivery

  • Numbers of participants with adverse pregnancy outcomes

    Including preterm birth, low birth weight, macrosomia, abortion, stillbirth, and birth defects. Hospital information system collection

    At delivery

Secondary Outcomes (9)

  • Weight in kilogram changes during childhood

    At birth and age at 42 days, 3 months, 6 months, 9 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 3.5 years, 4 years, 4.5years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years, 11years and 12 years

  • Height in centimeter changes during childhood

    At birth and age at 42 days, 3 months, 6 months, 9 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 3.5 years, 4 years, 4.5years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years, 11years and 12 years

  • Early Child development

    Age at 6 months, 48 months and 54 months

  • Child Psychological and Behavioural Development

    Age at 48 months, 60 months and 72 months

  • Child Intelligence quotient

    At age of 54 months

  • +4 more secondary outcomes

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

From May 2013 to September 2014, 3474 pregnant women who first established a maternal health handbook in Ma'anshan Maternal and Child Health Hospital (MCHH) and were willing to undergo regular obstetric checkups and deliveries in the hospital were selected for inclusion in the cohort.

You may qualify if:

  • Permanent residents of Ma'anshan city;
  • Obstetric examination and delivery at Ma'anshan Maternal and Child Health Hospital;
  • Mother's age ≥ 18 years old and gestational week ≤ 14 weeks;
  • No serious neuropsychiatric disorders, with sufficient understanding and expression to complete the survey.

You may not qualify if:

  • Intellectual disability or other serious mental disorders;
  • Suffering from serious underlying diseases and may have a significant impact on pregnancy outcome;
  • Those with poor compliance and difficulty in follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ma'anshan Maternal and Child Health Care Hospital

Ma’anshan, Anhui, 243011, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Pregnancy and delivery:maternal blood, urine, cord blood and placenta. During infancy: urine and blood. During school age:Blood, urine and hair mother-child pairs

MeSH Terms

Conditions

Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Fangbiao Tao

    Anhui Medical University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 6, 2017

First Posted

July 12, 2017

Study Start

May 16, 2013

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

April 12, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations