Continuation of the nuMoM2b Heart Health Study

Part of paid clinical trials in Orange, California.

Sponsor
RTI International
Study ID
NCT05472597
Status
Enrolling By Invitation

Conditions

  • Cardiovascular Diseases

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Nov 29, 2022
Status verified
Oct 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
4,048 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Incidence of hypertension (130/80 mmHg) [ Time Frame: Assessed during the HHS2 in-person visit, 8-16 years after the index pregnancy. ]

Locations (14)

FacilityCityStateZIPSite coordinators
University of California, Irvine Medical CenterOrangeCalifornia92868-
Christiana Care Health ServicesNewarkDelaware19718-
Northwestern UniversityChicagoIllinois60611-
Indiana UniversityIndianapolisIndiana46202-
Columbia University Medical CenterNew YorkNew York10032-
The MetroHealth SystemClevelandOhio44109-
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104-
Pennsylvania HospitalPhiladelphiaPennsylvania19107-
UPMC Magee Womens HospitalPittsburghPennsylvania15213-
Intermountain Medical CenterMurrayUtah84107-
McKay-Dee HospitalOgdenUtah84403-
Utah Valley HospitalProvoUtah84604-
LDS HospitalSalt Lake CityUtah84143-
University of UtahSalt Lake CityUtah84132-

Find similar trials in Orange, CA

By research site
University of California, Irvine Medical Center· Orange, CAChristiana Care Health Services· Newark, DENorthwestern University· Chicago, ILIndiana University· Indianapolis, INColumbia University Medical Center· New York, NYThe MetroHealth System· Cleveland, OH

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