Continuation of the nuMoM2b Heart Health Study

NCT05472597 | Enrolling By Invitation DMC

• 2 other identifiers: 00047665U01HL145358
• Study Type: observational
• Target: 4,048
• Locations: 1 country
• Sites: 14

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.

Conditions

Cardiovascular Diseases

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Incidence of hypertension (130/80 mmHg)

  Measured blood pressure \> 130/80 mmHg, use of antihypertensive medication, or self-report of a hypertension clinical diagnosis

  Assessed during the HHS2 in-person visit, 8-16 years after the index pregnancy.

• Incidence of diabetes

  Measured hemoglobin A1c GE 6.5%, fasting blood glucose GE 126 mg/dL, use of blood sugar lowering medication, or self-report of a diabetes clinical diagnosis

  Assessed during the HHS2 in-person visit, 8-16 years after the index pregnancy.

• Incidence of obesity

  Measured BMI GE 30 kg/m\^2

  Assessed during the HHS2 in-person visit, 8-16 years after the index pregnancy.

• Incidence of metabolic syndrome

  Per the American Heart Association standard definition: Any three of the following five - 1) waist circumference \> 35 inches (88 cm) for non-Asians and \> 31.5 inches (80 cm) for Asians; 2) triglycerides \> 150 mg/dL or medication treatment for high triglycerides; 3) high density lipoprotein (HDL) \< 50 mg/dL or medication treatment for low HDL; 4) a serum glucose ≥ 100 mg/dL or a diagnosis of diabetes mellitus; 5) systolic blood pressure (SBP) ≥ 130 mmHg or diastolic blood pressure (DBP) ≥ 85 mmHg, or medication treatment for hypertension.

  Assessed during the HHS2 in-person visit, 8-16 years after the index pregnancy.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All nuMoM2b-HHS2 cohort participants will be female. Males were excluded from the original nuMoM2b study because the focus of the study was on the relationship between pregnancy and CVD risk and events.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The original nuMoM2b cohort consisted of an ethnically and racially diverse group of pregnant women aged 13 or over who had not had a pregnancy lasting 20 weeks or more, enrolled during the first trimester. Overall, 62% of the nuMoM2b-HHS participants are non-Hispanic white, 14% non-Hispanic black, 16% Hispanic, and 8% mixed race or other. The socio-demographics on the nuMoM2b-HHS participants vary substantially by clinical site, contributing to a rich degree of diversity within the cohort.

You may qualify if:

• Completed one or more interval contacts during the nuMoM2b Heart Health Study.
• Able to speak or read in English or Spanish.

You may not qualify if:

• Withdrawal from study.
• 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.
• Current pregnancy.
• Withdrawal from study.

Sponsors & Collaborators

• RTI International: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Northwestern University: collaborator
• Ohio State University: collaborator
• Cedars-Sinai Medical Center: collaborator
• Case Western Reserve University: collaborator
• Columbia University: collaborator
• ChristianaCare: collaborator
• Indiana University: collaborator
• University of Pittsburgh: collaborator
• University of California, Irvine: collaborator
• University of Utah: collaborator
• University of Pennsylvania: collaborator
• Intermountain Health Care, Inc.: collaborator
• University of Michigan: collaborator
• West Virginia University: collaborator
• Old Dominion University: collaborator

Study Sites (14)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

Christiana Care Health Services

Newark, Delaware, 19718, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

The MetroHealth System

Cleveland, Ohio, 44109, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

UPMC Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

McKay-Dee Hospital

Ogden, Utah, 84403, United States

Location

Utah Valley Hospital

Provo, Utah, 84604, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

We are collecting whole blood, serum, plasma, buffy coat, and urine.

MeSH Terms

Conditions

Cardiovascular Diseases; Stillbirth; Premature Birth; Diabetes, Gestational

Condition Hierarchy (Ancestors)

Fetal Death; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• George Saade, MD

  Old Dominion University

  PRINCIPAL INVESTIGATOR

• Phillip Greenland, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Rebecca McNeil, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Statistician

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 25, 2022
• Study Start: November 29, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (14)