Boston Birth Cohort Study

Pregnancy Complications Clinical Trial

Official title:

Early Life Origins of Pediatric and Adult Diseases: Boston Birth Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03228875
• Other study ID #: Boston Birth Cohort
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Child Health
• Maternal Health
• Pregnancy Complications

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