Cardiovascular Diseases
Conditions
Keywords
Cardiovascular Diseases, Adverse Pregnancy Outcomes, Stillbirth, Small for Gestational Age, Preterm Birth, Hypertensive Diseases of Pregnancy, Gestational Diabetes
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 3-7, 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).
Interventions
None listed
Sponsors
RTI International
National Heart, Lung, and Blood Institute (NHLBI)
Northwestern University
Ohio State University
Cedars-Sinai Medical Center
Case Western Reserve University
Columbia University
ChristianaCare
Indiana University
University of California, Irvine
University of Utah
University of Pennsylvania
Intermountain Health Care, Inc.
University of Michigan
West Virginia University
Old Dominion University
Brown University
Magee-Women's Research Institute
University of Pittsburgh Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGeorge Saade, MD
Old Dominion University
PRINCIPAL_INVESTIGATORPhillip Greenland, MD
Northwestern University
PRINCIPAL_INVESTIGATORRebecca McNeil, PhD
RTI International
Outcome results
None listed