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Continuation of the nuMoM2b Heart Health Study

Study acronym: nuMoM2b-HHS2
StatusEnrolling by Invitation
PhaseNot specified
Started
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Record History

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  1. Study description revised
    • Study sites revised (14)
    • Collaborators: 16 to 18
    v6
  2. Collaborators revised (16)v5
  3. Study description revised
    • Collaborators: 14 to 16
    • Eligibility criteria expanded, about 5 words
    v4
  4. Start date: Oct 21, 2022 to Nov 29, 2022v3
  5. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Aug 2022 to Oct 21, 2022
    • Site contacts updated at 13 of 14 sites
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
RTI International
27 trials monitored
See 3 trials at risk
Heart Disease
8,786 trials monitored
See 412 trials at risk
Diabetes
5,087 trials monitored
See 222 trials at risk
Cardiovascular disease (CVD) is the leading cause of mortality and morbidity in U.S. women at all ages, and large knowledge gaps exist in CVD predictive and preventative strategies for women. The nuMoM2b Heart Health Study (nuMoM2b-HHS) has followed a demographically diverse cohort of women enrolled and richly phenotyped during their first pregnancy, with data and biospecimens prospectively collected for up to 7 years thereafter. The overarching scientific goal of this study is to define the relationship between adverse pregnancy outcomes (APOs) and CVD to optimize CVD prediction, prevention, and treatment strategies for women. Continued follow-up of this observational cohort, building on a foundation of existing high-quality data, biospecimens, and administrative structures with a robust framework for ancillary study development and implementation, provides a unique opportunity to address knowledge gaps regarding the early mechanisms and trajectory of CVD in women.
Trial Details
NCT Number NCT05472597
Lead Sponsor RTI International
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Northwestern University, Ohio State University, Cedars-Sinai Medical Center, Case Western Reserve University, Columbia University, ChristianaCare, Indiana University, University of California, Irvine, University of Utah, University of Pennsylvania, Intermountain Health Care, Inc., University of Michigan, West Virginia University, Old Dominion University, Brown University, Magee-Women's Research Institute, University of Pittsburgh Medical Center
Conditions
(from sponsor)		 Cardiovascular Diseases
Related terms Cardiovascular Diseases, Diabetes, Gestational, Premature Birth, Stillbirth
Enrollment 4,048 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov