nuMoM2b-HHS2: Continuation of the nuMoM2b Heart Health Study
Study Details
Study Description
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 | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Outcome Measures
Primary Outcome Measures
- Incidence of hypertension (130/80 mmHg) [Assessed during the HHS2 in-person visit, 8-16 years after the index pregnancy.]
Measured blood pressure > 130/80 mmHg, use of antihypertensive medication, or self-report of a hypertension clinical diagnosis
- Incidence of diabetes [Assessed during the HHS2 in-person visit, 8-16 years after the index pregnancy.]
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
- Incidence of obesity [Assessed during the HHS2 in-person visit, 8-16 years after the index pregnancy.]
Measured BMI GE 30 kg/m^2
- Incidence of metabolic syndrome [Assessed during the HHS2 in-person visit, 8-16 years after the index pregnancy.]
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.
Eligibility Criteria
Criteria
Inclusion Criteria for nuMoM2b-HHS2 interval contact (telephone interview or web-based self-administered survey):
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Completed one or more interval contacts during the nuMoM2b Heart Health Study.
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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:
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Completed one or more interval contacts during the nuMoM2b Heart Health Study.
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Self-report of at least 3 months postpartum from any subsequent pregnancy.
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Provision of signed informed consent for the HHS2 in-person research visit.
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Able to speak or read English or Spanish.
Exclusion Criteria for nuMoM2b-HHS2 in-person visit:
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Current pregnancy.
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Withdrawal from study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California, Irvine Medical Center | Orange | California | United States | 92868 |
| 2 | Christiana Care Health Services | Newark | Delaware | United States | 19718 |
| 3 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 4 | Indiana University | Indianapolis | Indiana | United States | 46202 |
| 5 | Columbia University Medical Center | New York | New York | United States | 10032 |
| 6 | The MetroHealth System | Cleveland | Ohio | United States | 44109 |
| 7 | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 8 | Pennsylvania Hospital | Philadelphia | Pennsylvania | United States | 19107 |
| 9 | UPMC Magee Womens Hospital | Pittsburgh | Pennsylvania | United States | 15213 |
| 10 | Intermountain Medical Center | Murray | Utah | United States | 84107 |
| 11 | McKay-Dee Hospital | Ogden | Utah | United States | 84403 |
| 12 | Utah Valley Hospital | Provo | Utah | United States | 84604 |
| 13 | University of Utah | Salt Lake City | Utah | United States | 84132 |
| 14 | LDS Hospital | Salt Lake City | Utah | United States | 84143 |
Sponsors and Collaborators
- RTI International
- National Heart, Lung, and Blood Institute (NHLBI)
- The University of Texas Medical Branch, Galveston
- Northwestern University
- Ohio State University
- Cedars-Sinai Medical Center
- Case Western Reserve University
- Columbia University
- ChristianaCare
- Indiana University
- University of Pittsburgh
- University of California, Irvine
- University of Utah
- University of Pennsylvania
- Intermountain Health Care, Inc.
Investigators
- Principal Investigator: George Saade, MD, University of Texas Medical Branch, Galveston
- Principal Investigator: Phillip Greenland, MD, Northwestern University
- Principal Investigator: Rebecca McNeil, MD, RTI International
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 00047665
- U01HL145358