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Enrolling by invitation NCT05472597

Continuation of the nuMoM2b Heart Health Study

— Observational Cardiovascular Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cardiovascular Diseases. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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 a study visit in years 3-7, 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 study visits (or participation in additional study visits).

Primary outcome measures

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 14 centers
  • University of California, Irvine Medical Center — Orange
  • Christiana Care Health Services — Newark
  • Northwestern University — Chicago
  • Indiana University — Indianapolis
  • Columbia University Medical Center — New York
  • Case Western Reserve University/The MetroHealth System — Cleveland
  • Hospital of the University of Pennsylvania — Philadelphia
  • Pennsylvania Hospital — Philadelphia
  • … and 6 more centers

Identifiers

NCT: NCT05472597 · 00047665 · U01HL145358

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗