Continuation of the nuMoM2b Heart Health Study
- Conditions
- Cardiovascular Diseases
- Registration Number
- NCT05472597
- Lead Sponsor
- RTI International
- 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.
- 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).
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- Female
- Target Recruitment
- 4048
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Northwestern University
🇺🇸Chicago, Illinois, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States
The MetroHealth System
🇺🇸Cleveland, Ohio, United States
UPMC Magee Womens Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University of California, Irvine Medical Center
🇺🇸Orange, California, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
McKay-Dee Hospital
🇺🇸Ogden, Utah, United States
Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
LDS Hospital
🇺🇸Salt Lake City, Utah, United States
Utah Valley Hospital
🇺🇸Provo, Utah, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States