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NCT05472597 | Enrolling by invitation | Cardiovascular Diseases


Continuation of the nuMoM2b Heart Health Study
Sponsor:

RTI International

Brief 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.

Condition or disease

Cardiovascular Diseases

Detailed Description:

The Continuation of nuMoM2b Heart Health Study (nuMoM2b-HHS2) will include prospectively collected longitudinal data on CVD risk factors and early clinical manifestations of CVD, the study's primary outcomes of interest. Measures completed during semiannual follow-ups will include 1) self-reported interval medical history, including medications and substance use; 2) interval pregnancy and postpartum history; 3) interval CVD events, conditions, and diagnostic and therapeutic procedures including CVD death, myocardial infarction (MI), stroke, transient ischemic attack (TIA), pulmonary embolism (PE), deep vein thrombosis (DVT), peripheral vascular disease, kidney disease, hypertension, diabetes, hyperlipidemia, and associated hospitalizations and procedures. During an in-person visit in years 3-5, 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).

Study Type : Observational
Estimated Enrollment : 4048 participants
Official Title: Continuation of the nuMoM2b Heart Health Study
Actual Study Start Date : October 21, 2022
Estimated Primary Completion Date : January 2027
Estimated Study Completion Date : January 2027

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: Accepts Healthy Volunteers
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 in-person visit
    • Completed one or more interval contacts during the nuMoM2b Heart Health Study.
    • Self-report of at least 3 months postpartum from any subsequent pregnancy.
    • Provision of signed informed consent for the HHS2 in-person research visit.
    • Able to speak or read English or Spanish.
    Exclusion Criteria for nuMoM2b-HHS2 in-person visit
    • Current pregnancy.
    • Withdrawal from study.

Continuation of the nuMoM2b Heart Health Study

Location Details


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Continuation of the nuMoM2b Heart Health Study

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

United States, California

University of California, Irvine Medical Center

Orange, California, United States, 92868

Not yet recruiting

United States, Delaware

Christiana Care Health Services

Newark, Delaware, United States, 19718

Not yet recruiting

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

Not yet recruiting

United States, Indiana

Indiana University

Indianapolis, Indiana, United States, 46202

Not yet recruiting

United States, New York

Columbia University Medical Center

New York, New York, United States, 10032

Not yet recruiting

United States, Ohio

The MetroHealth System

Cleveland, Ohio, United States, 44109

Not yet recruiting

United States, Pennsylvania

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Not yet recruiting

United States, Pennsylvania

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States, 19107

Not yet recruiting

United States, Pennsylvania

UPMC Magee Womens Hospital

Pittsburgh, Pennsylvania, United States, 15213

Not yet recruiting

United States, Utah

Intermountain Medical Center

Murray, Utah, United States, 84107

Not yet recruiting

United States, Utah

McKay-Dee Hospital

Ogden, Utah, United States, 84403

Not yet recruiting

United States, Utah

Utah Valley Hospital

Provo, Utah, United States, 84604

Not yet recruiting

United States, Utah

University of Utah

Salt Lake City, Utah, United States, 84132

Not yet recruiting

United States, Utah

LDS Hospital

Salt Lake City, Utah, United States, 84143

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