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Boston Birth Cohort Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03228875
Recruitment Status : Recruiting
First Posted : July 25, 2017
Last Update Posted : October 5, 2022
Sponsor:
Collaborator:
Boston Medical Center
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Brief 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.

Condition or disease
Maternal Health Child Health Pregnancy Complications Birth Outcome, Adverse

Detailed 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 24000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 21 Years
Official Title: Early Life Origins of Pediatric and Adult Diseases: Boston Birth Cohort Study
Actual Study Start Date : October 1998
Estimated Primary Completion Date : December 2028
Estimated Study Completion Date : December 2028



Primary Outcome Measures :
  1. Pregnancy complications [ Time Frame: At birth ]
    Multiple pregnancy complications are examined including gestational diabetes, hypertensive disorders of pregnancy.

  2. Birth outcomes - preterm birth [ Time Frame: At birth ]
    Birth outcomes are examined - preterm birth.

  3. Birth outcomes - birthweight [ Time Frame: At birth ]
    Birth outcomes are examined - birthweight.

  4. Child health outcomes [ Time Frame: From birth to 21 years ]
    Multiple child health outcomes are examined including food allergy, asthma, child's overweight or obesity, blood pressure, and child neuro-developmental outcomes.

  5. Maternal health outcomes [ Time Frame: After delivery to 21 years ]
    Multiple maternal health outcomes are measured including blood pressure, weight, height, physician diagnosis.


Biospecimen Retention:   Samples With DNA
Plasma, red blood cell, placenta, urine, DNA, RNA, Swab, Stool


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   0 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
US, predominantly urban, BIPOC (Black, Indigenous, and people of color).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228875


Contacts
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Contact: Xiaobin Wang, MD, ScD 410-9555824 xwang82@jhu.edu

Locations
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United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Colleen Pearson, BA    617-414-5133    Colleen.pearson@bmc.org   
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Boston Medical Center
Investigators
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Principal Investigator: Xiaobin Wang, MD, ScD Johns Hopkins Bloomberg School of Public Health
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT03228875    
Other Study ID Numbers: Boston Birth Cohort
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: October 5, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Boston Birth Cohort
Early life origins of pediatric and adult disease
Gene environment interaction
Health across life course and generations
Additional relevant MeSH terms:
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Pregnancy Complications