Summary

Eligibility
for females ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at Orange, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Judith Chung, MD, PhD

Description

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.

Details

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).

Keywords

Cardiovascular Diseases Adverse Pregnancy Outcomes Stillbirth Small for Gestational Age Preterm Birth Hypertensive Diseases of Pregnancy Gestational Diabetes

Eligibility

You can join if…

Open to females ages 18 years and up

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.

You CAN'T join if...

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.

Locations

  • University of California, Irvine Medical Center
    Orange California 92868 United States
  • Utah Valley Hospital
    Provo Utah 84604 United States

Lead Scientist at UC Irvine

  • Judith Chung, MD, PhD
    Clinical Professor, Obstetrics and Gynecology, School of Medicine. Authored (or co-authored) 54 research publications. Research interests: Diabetes in pregnancy · hospital site of delivery for high risk pregnancies · clinical research design

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
RTI International
ID
NCT05472597
Study Type
Observational
Participants
Expecting 4048 study participants
Last Updated