Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Determinants of Preterm Birth in Boston Birth Cohort

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 : July 25, 2017
Sponsor:
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 pregnancy, infancy, and child health outcomes.

Condition or disease
Preterm Birth Birthweight Pregnancy Complications

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.

The Boston Birth Cohort has high-quality biospecimen collection, and comprehensive epidemiological, clinical, and environmental exposure data via standardized questionnaire interview and review of the electronic medical records.


Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 12000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 21 Years
Official Title: Molecular Epidemiology of Preterm Birth: Environmental and Genetic Interactions Repository
Actual Study Start Date : October 1998
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022



Primary Outcome Measures :
  1. preterm birth [ Time Frame: at birth ]
    preterm birth is defined as gestational age less than 37 weeks

  2. birthweight [ Time Frame: at birth ]
    low birthweight is particularly focused on.

  3. pregnancy complications [ Time Frame: at delivery ]
    multiple pregnancy complications are examined including gestational diabetes, hypertensive disorders during pregnancy


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


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.


Layout table for eligibility information
Ages Eligible for Study:   13 Years to 51 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
low incomes, urban, minorities
Criteria

Inclusion Criteria:

  • Mothers who deliver singleton live births 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
Layout table for location contacts
Contact: Colleen Pearson, BA 617-414-5133 colleen.pearson@bmc.org

Locations
Layout table for location information
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Barry Zuckerman, MD    617-414-5133    barry.zuckerman@bmc.org   
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Investigators
Layout table for investigator information
Principal Investigator: Xiaobin Wang, MD, ScD Johns Hopkins Bloomberg School of Public Health

Additional Information:

Layout table for additonal information
Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT03228875     History of Changes
Other Study ID Numbers: Boston birth cohort
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
pregnancy outcomes, birth outcomes
Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Pregnancy Complications
Birth Weight
Obstetric Labor, Premature
Obstetric Labor Complications
Body Weight
Signs and Symptoms