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Environmental ExposureNCT03215368

The Ma'Anshan Birth Cohort (MABC)

An observational study of Environmental Exposure and Pregnancy Outcome, run by Anhui Medical University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 44 years, women onlyHealthy volunteers can take part
How many people
3,474 participants
Where
1 siteChina
Study dates
16 May 2013to 30 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 44 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Ma'anshan Maternal and Child Health Care Hospital

    Ma’anshan, Anhui, 243011

Other trials in China

About this study

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.

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.

Keywords
birth cohort study, environmental exposures, birth defects, pregnant outcomes, children development, Maternal and child health
Medical subject headings
Congenital Abnormalities

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numbers of participants with pregnancy complications

    Including gestational diabetes, gestational hypertension, anemia, and hypothyroidism during pregnancy.

    Diagnosis by medical personnel at clinics

    Measured: At delivery

  2. Numbers of participants with adverse pregnancy outcomes

    Including preterm birth, low birth weight, macrosomia, abortion, stillbirth, and birth defects.

    Hospital information system collection

    Measured: At delivery

Secondary outcomes (9)

  1. Weight in kilogram changes during childhood

    Measured by health professionals in the clinic.

    Measured: 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

  2. Height in centimeter changes during childhood

    Measured by health professionals in the clinic.

    Measured: 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

  3. Early Child development

    Measured by Ages\&Stages Questionnaires (ASQ). There are 6 questions in each of 5 domains of development: communication, gross motor, fine motor, problem-solving skills, and adaptive skills. Each question is given a 10 (yes), 5 (sometimes), or 0 (not yet) score according to the parents' answers. The sum scores (range from 0 to 300) and scores for each domain (range from 0 to 60) are calculated. Chinese norms are available for each domain, and any domain screened <2 SDs below the mean is considered a positive screening. A higher ASQ score means better development.

    Measured: Age at 6 months, 48 months and 54 months

  4. Child Psychological and Behavioural Development

    Measured by Strengths and Difficulties Questionnaire(SDQ). SDQ consisted of 25 entries scored on a 3-point scale from 0 to 2. 0: "Doesn't meet"; 1: "Somewhat meets"; 2: "Completely meets"; and the results were summarized into 5 factors: emotional factor, conduct factor, hyperactivity factor, peer factor, and pro-social factor, each with a score range of 0 to 10. The results were categorized into five factors: Emotional, Conduct, Hyperactivity, Peer, and Pro-social, each of which has a score range of 0-10 points. The sum of the scores of the first four factors is the total difficulty score of the SDQ, and the higher the score, the more serious the objective difficulty is. The higher the score, the better the pro-social ability.

    Measured: Age at 48 months, 60 months and 72 months

  5. Child Intelligence quotient

    Assessed by using Wechsler Preschool and Primary Scale of Intelligence-Fourth Edition-Chinese (WPPSI-IV（CN）), which can generate a full scale intelligence quotient score and five primary index scores including verbal comprehension, visual spatial, fluid reasoning, working memory, and processing speed. Intelligence quotient ranges from 40 to 160, in which less than 70 is defined as mental retardation

    Measured: At age of 54 months

  6. Child Sexual Development Indicators

    Secondary sexual characters, Sexual hormones. Staging of puberty using Tanners classification: Testicular size of boys assessed by Prader's testerometer suggests possible precocious puberty if testicular development occurs before the age of 9 years in boys, and if breast development occurs before the age of 7.5 years or first menstruation occurs before the age of 10 years in girls. In order to further determine the existence and classification of precocious puberty, ultrasound examination of the uterus and ovaries for girls and ultrasound examination of the testes for boys are required. In addition to the above tests, bone age assessment, bone density test, adrenal gland ultrasound, thyroid function, sex hormone 6, alpha-fetoprotein measurement, growth hormone stimulation test and gonadotropin-releasing hormone stimulation test are also performed to further confirm the diagnosis.

    Measured: At ages of 9-15 years for boys, and 8-14 years for girls

  7. Incidence of child overweight and obesity

    Measured by health professionals in clinic.

    Measured: 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

  8. Fetal Head Circumference

    Measured by health professionals in clinic with ultrasound.

    Measured: At delivery.

  9. Fetal Abdominal Circumference

    Measured by health professionals in clinic with ultrasound.

    Measured: At delivery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2017
  2. Study start16 May 2013
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,474 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03215368
Sponsor's protocol ID
20131195
Status last verified
Apr 2024
First submitted
6 Jul 2017
Last updated
12 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Environmental Exposure and Pregnancy Outcome, run by Anhui Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numbers of participants with pregnancy complications (time frame: At delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03215368.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.

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