Continuation of the nuMoM2b Heart Health Study (nuMoM2b-HHS2)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: 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 a study visit in years 3-6, 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
• Enrollment (Estimated): 4048

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • University of California, Irvine Medical Center
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Care Health Services
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • The MetroHealth System
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Pennsylvania Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Magee Womens Hospital
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
    • Ogden, Utah, United States, 84403
      • McKay-Dee Hospital
    • Provo, Utah, United States, 84604
      • Utah Valley Hospital
    • Salt Lake City, Utah, United States, 84132
      • University of Utah
    • Salt Lake City, Utah, United States, 84143
      • LDS Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: RTI International
• Collaborators: University of Pennsylvania; National Heart, Lung, and Blood Institute (NHLBI); Northwestern University; Columbia University; University of Pittsburgh; University of Michigan; Ohio State University; University of California, Irvine; Cedars-Sinai Medical Center; University of Utah; Indiana University; Case Western Reserve University; West Virginia University; Intermountain Health Care, Inc.; Old Dominion University; ChristianaCare
• Investigators: Principal Investigator: Phillip Greenland, MD, Northwestern University; Principal Investigator: George Saade, MD, Old Dominion University; Principal Investigator: Rebecca McNeil, PhD, RTI International

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Estimated): October 21, 2025
• Last Update Submitted That Met QC Criteria: October 17, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Gestational Diabetes; Preterm Birth; Stillbirth; Adverse Pregnancy Outcomes; Small for Gestational Age; Hypertensive Diseases of Pregnancy
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes Mellitus; Death; Fetal Death; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Premature Birth; Diabetes, Gestational; Cardiovascular Diseases; Stillbirth
• Other Study ID Numbers: 00047665; U01HL145358 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data will be made available through an NIH data repository.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No