- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03228875
Boston Birth Cohort Study
Early Life Origins of Pediatric and Adult Diseases: Boston Birth Cohort Study
Study Overview
Status
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Xiaobin Wang, MD, ScD
- Phone Number: 410-9555824
- Email: xwang82@jhu.edu
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Recruiting
- Boston Medical Center
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Contact:
- Colleen Pearson, BA
- Phone Number: 617-414-5133
- Email: Colleen.pearson@bmc.org
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pregnancy complications
Time Frame: At birth
|
Multiple pregnancy complications are examined including gestational diabetes, hypertensive disorders of pregnancy.
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At birth
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Birth outcomes - preterm birth
Time Frame: At birth
|
Birth outcomes are examined - preterm birth.
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At birth
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Birth outcomes - birthweight
Time Frame: At birth
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Birth outcomes are examined - birthweight.
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At birth
|
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.
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From birth to 21 years
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Maternal health outcomes
Time Frame: After delivery to 21 years
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Multiple maternal health outcomes are measured including blood pressure, weight, height, physician diagnosis.
|
After delivery to 21 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Xiaobin Wang, MD, ScD, Johns Hopkins Bloomberg School of Public Health
Publications and helpful links
General Publications
- McArthur KL, Zhang M, Hong X, Wang G, Buckley JP, Wang X, Mueller NT. Trimethylamine N-Oxide and Its Precursors Are Associated with Gestational Diabetes Mellitus and Pre-Eclampsia in the Boston Birth Cohort. Curr Dev Nutr. 2022 Jun 21;6(7):nzac108. doi: 10.1093/cdn/nzac108. eCollection 2022 Jul.
- Huang W, Igusa T, Wang G, Buckley JP, Hong X, Bind E, Steffens A, Mukherjee J, Haltmeier D, Ji Y, Xu R, Hou W, Tina Fan Z, Wang X. In-utero co-exposure to toxic metals and micronutrients on childhood risk of overweight or obesity: new insight on micronutrients counteracting toxic metals. Int J Obes (Lond). 2022 Aug;46(8):1435-1445. doi: 10.1038/s41366-022-01127-x. Epub 2022 May 19.
- Lee ASE, Ji Y, Raghavan R, Wang G, Hong X, Pearson C, Mirolli G, Bind E, Steffens A, Mukherjee J, Haltmeier D, Fan ZT, Wang X. Maternal prenatal selenium levels and child risk of neurodevelopmental disorders: A prospective birth cohort study. Autism Res. 2021 Dec;14(12):2533-2543. doi: 10.1002/aur.2617. Epub 2021 Sep 24.
- Olapeju B, Hong X, Wang G, Summers A, Burd I, Cheng TL, Wang X. Birth outcomes across the spectrum of maternal age: dissecting aging effect versus confounding by social and medical determinants. BMC Pregnancy Childbirth. 2021 Sep 1;21(1):594. doi: 10.1186/s12884-021-04077-w.
- Olapeju B, Ahmed S, Hong X, Wang G, Summers A, Cheng TL, Burd I, Wang X. Maternal Hypertensive Disorders in Pregnancy and Postpartum Plasma B Vitamin and Homocysteine Profiles in a High-Risk Multiethnic U.S., Population. J Womens Health (Larchmt). 2020 Dec;29(12):1520-1529. doi: 10.1089/jwh.2020.8420. Epub 2020 Nov 16.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Boston Birth Cohort
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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