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Enrolling By Invitation
NCT05472597
Continuation of the nuMoM2b Heart Health Study
Conditions: Cardiovascular Diseases
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 4048
Sponsor: RTI International
Location: University of California, Irvine Medical Center Orange California
Summary
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.
Eligibility Criteria
Inclusion Criteria for nuMoM2b-HHS2 interval contact (telephone interview or web-based self-administered survey):
* Completed one or more interval contacts during the nuMoM2b Heart Health Study.
* Able to speak or read in English or Spanish.
Exclusion Criteria for nuMoM2b-HHS2 interval contact (telephone interview or web-based self-administered survey):
* Withdrawal from study.
Inclusion Criteria for nuMoM2b-HHS2 study visit:
* 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 for nuMoM2b-HHS2 study visit:
* Current pregnancy.
* Withdrawal from study.
Source: ClinicalTrials.gov (NCT05472597). StuddyBuddy aggregates publicly available trial information.