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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03228875
Other study ID # Boston Birth Cohort
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1998
Est. completion date December 2028

Study information

Verified date September 2023
Source Johns Hopkins Bloomberg School of Public Health
Contact Xiaobin Wang, MD, ScD
Phone 410-9555824
Email xwang82@jhu.edu
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Early life exposures may lead to adverse effects on health in later life. The Boston birth Cohort study is designed to study a broad array of early life factors and their effects on maternal and child health outcomes.


Description:

Any woman admitted to the Labor and Delivery floor at the Boston Medical Center (BMC) who delivers a singleton live infant and meets our case (gestational age <37 weeks or birthweight <2,500 grams) or control (full term birth with birthweight >2,500 grams) criteria will be eligible. Postnatal follow-up of enrolled mother-child pair is conducted from birth to age 21 years. The Boston Birth Cohort has high-quality biospecimen collection, and comprehensive epidemiological, clinical, and environmental exposure data via standardized questionnaire interview, measurements, and review of the electronic medical records.


Recruitment information / eligibility

Status Recruiting
Enrollment 24000
Est. completion date December 2028
Est. primary completion date December 2028
Accepts healthy volunteers No
Gender All
Age group 0 Years to 21 Years
Eligibility Inclusion Criteria: - Mothers who deliver singleton live births at Boston Medical Center are eligible for the study. Exclusion Criteria: - pregnancies that are a result of in vitro fertilization or that involve multiple gestations, fetal chromosomal abnormalities or major birth defects.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Boston Medical Center Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins Bloomberg School of Public Health Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pregnancy complications Multiple pregnancy complications are examined including gestational diabetes, hypertensive disorders of pregnancy. At birth
Primary Birth outcomes - preterm birth Birth outcomes are examined - preterm birth. At birth
Primary Birth outcomes - birthweight Birth outcomes are examined - birthweight. At birth
Primary Child health outcomes Multiple child health outcomes are examined including food allergy, asthma, child's overweight or obesity, blood pressure, and child neuro-developmental outcomes. From birth to 21 years
Primary Maternal health outcomes Multiple maternal health outcomes are measured including blood pressure, weight, height, physician diagnosis. After delivery to 21 years
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