Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
4048 participants
OBSERVATIONAL
2022-11-29
2027-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Epidemiology of Cardiovascular Risk Factors in Women (Healthy Women Study)
NCT00005160
Genomic Basis of Neurodevelopmental and Brain Outcomes in Congenital Heart Disease (CHD Brain and Genes)
NCT03070197
Nurses' Health Study (Cardiovascular Component)
NCT00005152
Precursors of CVD Risk Factors--Project Heartbeat
NCT00005478
Pediatric Epidemiology of Cardiovascular Disease Risk Factors (Project Heartbeat)
NCT00005264
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
During a study visit in years 3-6, the participant's blood pressure, pulse rate, weight, height, and body measurements will be recorded. During the visit, a fasting blood draw and clean-catch urine specimen will be collected. Aliquots of whole blood, plasma, serum, and urine will be stored at the biorepository; these will be analyzed for CVD measures of lipids, triglycerides, and glucose, among others. Measures of behavioral risk factors, including nutrition, physical activity, and stress will also be completed.
Ancillary studies will expand data collection during the follow-up contacts and in-person visit, and add to the planned contact schedule, to permit the effective targeting of knowledge gaps required to optimize predictive and preventative strategies. Some ancillary studies will only rely on extant data, while others will require de novo data collection during the planned follow-up contacts and/or in-person visits (or participation in additional in-person visits).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
nuMoM2b Heart Health Study Cohort
A large and diverse (both geographically and demographically) group of adult women enrolled and richly phenotyped during their first pregnancy, with data and biospecimens prospective collected thereafter.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Able to speak or read in English or Spanish.
* Completed one or more interval contacts during the nuMoM2b Heart Health Study.
* At least 18 years of age.
* Self-report of at least 3 months postpartum from any subsequent pregnancy.
* Provision of signed informed consent for the HHS2 study visit.
* Able to speak or read English or Spanish.
Exclusion Criteria
* Current pregnancy.
* Withdrawal from study.
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Northwestern University
OTHER
Ohio State University
OTHER
Cedars-Sinai Medical Center
OTHER
Case Western Reserve University
OTHER
Columbia University
OTHER
ChristianaCare
OTHER
Indiana University
OTHER
University of Pittsburgh
OTHER
University of California, Irvine
OTHER
University of Utah
OTHER
University of Pennsylvania
OTHER
Intermountain Health Care, Inc.
OTHER
University of Michigan
OTHER
West Virginia University
OTHER
Old Dominion University
OTHER
RTI International
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Becky McNeil
Senior Research Statistician
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
George Saade, MD
Role: PRINCIPAL_INVESTIGATOR
Old Dominion University
Phillip Greenland, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Rebecca McNeil, PhD
Role: PRINCIPAL_INVESTIGATOR
RTI International
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California, Irvine Medical Center
Orange, California, United States
Christiana Care Health Services
Newark, Delaware, United States
Northwestern University
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Columbia University Medical Center
New York, New York, United States
The MetroHealth System
Cleveland, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
UPMC Magee Womens Hospital
Pittsburgh, Pennsylvania, United States
Intermountain Medical Center
Murray, Utah, United States
McKay-Dee Hospital
Ogden, Utah, United States
Utah Valley Hospital
Provo, Utah, United States
University of Utah
Salt Lake City, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
00047665
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.