Clinical trial NCT03215368: The Ma'Anshan Birth Cohort (MABC)
Official title: A Population-Based Prospective Cohort Study to Examine the Effects of Maternal Pregnancy Exposure on Adverse Pregnancy Outcomes, Child Health and Their Development.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Environmental Exposure
Pregnancy Outcome
Birth Defects
Child Development
Maternal and Child Health
Health Problems in Pregnancy
Keywords: birth cohort study
environmental exposures
birth defects
pregnant outcomes
children development
Maternal and child health
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
Collaborators: name: Ma'anshan Maternal and Child Health Care Hospital
First posted: 2017-07-12
Enrollment: 3474
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.


Eligibility criteria: Inclusion Criteria

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

Exclusion criteria:

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

Primary outcomes:
measure: Numbers of participants with pregnancy complications
timeFrame: At delivery
measure: Numbers of participants with adverse pregnancy outcomes
timeFrame: At delivery
Secondary outcomes:
measure: Weight in kilogram changes during childhood
timeFrame: 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
measure: Height in centimeter changes during childhood
timeFrame: 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
measure: Early Child development
timeFrame: Age at 6 months, 48 months and 54 months
measure: Child Psychological and Behavioural Development
timeFrame: Age at 48 months, 60 months and 72 months
measure: Child Intelligence quotient
timeFrame: At age of 54 months
measure: Child Sexual Development Indicators
timeFrame: At ages of 9-15 years for boys, and 8-14 years for girls
measure: Incidence of child overweight and obesity
timeFrame: 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
measure: Fetal Head Circumference
timeFrame: At delivery.
measure: Fetal Abdominal Circumference
timeFrame: At delivery.
Other outcomes:
Locations:
city: Ma'anshan
country: China
facility: Ma'anshan Maternal and Child Health Care Hospital
state: Anhui
Study officials:
affiliation: Anhui Medical University
name: Fangbiao Tao
role: STUDY_DIRECTOR
References: