Maternal HealthNCT03228875
Boston Birth Cohort Study
An observational study of Maternal Health and Child Health, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
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 across the life course. Read more about this study
- Who is it for?
- Ages 0 to 50 years
- Conditions the study is for
- Maternal Health, Child Health, Pregnancy Complications
- How many people
- 24,000 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1998to Dec 2032
- How long will I take part?
- 21 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: US, predominantly urban, multi-ethnic population.
Who may be able to join
- Mothers who deliver singleton live births at Boston Medical Center are eligible for the study.
Who cannot join
- pregnancies that are a result of in vitro fertilization or that involve multiple gestations, fetal chromosomal abnormalities or major birth defects.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
Colleen Pearson, BA, 617-414-5133, Colleen.pearson@bmc.org
About this study
Official title: Early Life Origins of Pediatric and Adult Diseases: Boston Birth Cohort Study
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 across the life course.
Read the 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.
- Keywords
- Boston Birth Cohort, Early life origins of pediatric and adult disease, Gene environment interaction, Health across life course and generations
- Medical subject headings
- Pregnancy Complications, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants with Pregnancy complications - including hypertensive disorders and gestational diabetes
hypertensive disorders during pregnancy, gestational diabetes
Measured: At birth
Birth outcomes - number of participants with preterm births
Birth outcomes are examined - preterm birth.
Measured: At birth
Birth outcomes - birth weight in grams (g)
Birth outcomes are examined - birth weight (g)
Measured: At birth
Child health outcomes - number of participants overweight or obese
overweight or obesity
Measured: From birth to 21 years
Maternal health outcomes - number of participants with maternal diabetes
maternal diabetes
Measured: After delivery to 21 years
child health outcome - systolic and diastolic blood pressure
blood pressure (mmHg)
Measured: from birth to 21 years
child health outcome - participants with neuro-developmental disorders including autism and ADHD
neuro-developmental disorders including autism and ADHD
Measured: from birth to 21 years
child health outcome - number of participants with asthma
asthma
Measured: from birth to 21 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study startOct 1998
- Primary completionDec 2028 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Maternal HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24,000 participants (estimated)
- Target duration
- 21 Years
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Medical Center, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Xiaobin Wang, MD, ScD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228875
- Sponsor's protocol ID
- IRB00022869
- Status last verified
- Sep 2026
- First submitted
- 20 Jul 2017
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pearson C, Bartell T, Wang G, Hong X, Rusk SA, Fu L, Cerda S, Bustamante-Helfrich B, Kuohung W, Yarrington C, Adams WG, Wang X. Boston Birth Cohort profile: rationale and study design. Precis Nutr. 2022 Aug 18;1(2):e00011. doi: 10.1097/PN9.0000000000000011. eCollection 2022 Sep.
PubMed 37745944Yaskolka Meir A, Wang G, Hong X, Hu FB, Wang X, Liang L. Newborn DNA methylation age differentiates long-term weight trajectories: the Boston Birth Cohort. BMC Med. 2024 Sep 11;22(1):373. doi: 10.1186/s12916-024-03568-9.
PubMed 39256781Cameron K, Borahay M, Hong X, Baker V, Vaught A, Wang X. Uterine fibroids and risk of hypertensive disorders of pregnancy - results from a racially diverse high-risk cohort. medRxiv [Preprint]. 2024 Mar 7:2024.03.05.24303830. doi: 10.1101/2024.03.05.24303830.
PubMed 38496516Hong X, Rosenberg AZ, Heymann J, Yoshida T, Waikar SS, Ilori TO, Wang G, Rebuck H, Pearson C, Wang MC, Winkler CA, Kopp JB, Wang X. Joint Associations of Pregnancy Complications and Postpartum Maternal Renal Biomarkers With Severe Cardiovascular Morbidities: A US Racially and Ethnically Diverse Prospective Birth Cohort Study. J Am Heart Assoc. 2023 Nov 21;12(22):e029311. doi: 10.1161/JAHA.122.029311. Epub 2023 Nov 10.
PubMed 37947096McArthur 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.
PubMed 35949367Huang 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.
PubMed 35589962Lee 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.
PubMed 34558795Olapeju 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.
PubMed 34470614Olapeju 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.
PubMed 33252313
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Life Origins of Pediatric and Adult Diseases: Boston Birth Cohort Study
- ClinicalTrials.gov ID
- NCT03228875
- Acronym / sponsor ID
- IRB00022869
- Keywords
- Boston Birth Cohort, Early life origins of pediatric and adult disease, Gene environment interaction, Health across life course and generations
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 24,000 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Boston Medical Center, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Oct 1998 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 25 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 across the life course.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 21 Years
Who may qualify
- Ages
- 0 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- US, predominantly urban, multi-ethnic population.
Key inclusion criteria (1 listed)
- Mothers who deliver singleton live births at Boston Medical Center are eligible for the study.
Key exclusion criteria (1 listed)
- pregnancies that are a result of in vitro fertilization or that involve multiple gestations, fetal chromosomal abnormalities or major birth defects.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Participants with Pregnancy complications - including hypertensive disorders and gestational diabetes
Time frame: At birth
hypertensive disorders during pregnancy, gestational diabetes
Birth outcomes - number of participants with preterm births
Time frame: At birth
Birth outcomes are examined - preterm birth.
Birth outcomes - birth weight in grams (g)
Time frame: At birth
Birth outcomes are examined - birth weight (g)
Child health outcomes - number of participants overweight or obese
Time frame: From birth to 21 years
overweight or obesity
Maternal health outcomes - number of participants with maternal diabetes
Time frame: After delivery to 21 years
maternal diabetes
child health outcome - systolic and diastolic blood pressure
Time frame: from birth to 21 years
blood pressure (mmHg)
child health outcome - participants with neuro-developmental disorders including autism and ADHD
Time frame: from birth to 21 years
neuro-developmental disorders including autism and ADHD
child health outcome - number of participants with asthma
Time frame: from birth to 21 years
asthma
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Results publication: PubMed 37745944Pearson C, Bartell T, Wang G, Hong X, Rusk SA, Fu L, Cerda S, Bustamante-Helfrich B, Kuohung W, Yarrington C, Adams WG, Wang X. Boston Birth Cohort profile: rationale and study design. Precis Nutr. 2022 Aug 18;1(2):e00011. doi: 10.1097/PN9.0000000000000011. eCollection 2022 Sep.
- Derived from this study: PubMed 39256781Yaskolka Meir A, Wang G, Hong X, Hu FB, Wang X, Liang L. Newborn DNA methylation age differentiates long-term weight trajectories: the Boston Birth Cohort. BMC Med. 2024 Sep 11;22(1):373. doi: 10.1186/s12916-024-03568-9.
- Derived from this study: PubMed 38496516Cameron K, Borahay M, Hong X, Baker V, Vaught A, Wang X. Uterine fibroids and risk of hypertensive disorders of pregnancy - results from a racially diverse high-risk cohort. medRxiv [Preprint]. 2024 Mar 7:2024.03.05.24303830. doi: 10.1101/2024.03.05.24303830.
- Derived from this study: PubMed 37947096Hong X, Rosenberg AZ, Heymann J, Yoshida T, Waikar SS, Ilori TO, Wang G, Rebuck H, Pearson C, Wang MC, Winkler CA, Kopp JB, Wang X. Joint Associations of Pregnancy Complications and Postpartum Maternal Renal Biomarkers With Severe Cardiovascular Morbidities: A US Racially and Ethnically Diverse Prospective Birth Cohort Study. J Am Heart Assoc. 2023 Nov 21;12(22):e029311. doi: 10.1161/JAHA.122.029311. Epub 2023 Nov 10.
- Derived from this study: PubMed 35949367McArthur 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.
- Derived from this study: PubMed 35589962Huang 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.
- Derived from this study: PubMed 34558795Lee 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.
- Derived from this study: PubMed 34470614Olapeju 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.
- Derived from this study: PubMed 33252313Olapeju 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaobin Wang, MD, ScD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maternal Health and Child Health, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaobin Wang, MD, ScD (410-9555824, xwang82@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants with Pregnancy complications - including hypertensive disorders and gestational diabetes (time frame: At birth). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03228875, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.