Clinical trial NCT05472597: Continuation of the nuMoM2b Heart Health Study
Official title: Continuation of the nuMoM2b Heart Health Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cardiovascular Diseases
Keywords: Cardiovascular Diseases
Adverse Pregnancy Outcomes
Stillbirth
Small for Gestational Age
Preterm Birth
Hypertensive Diseases of Pregnancy
Gestational Diabetes
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Northwestern University
name: Ohio State University
name: Cedars-Sinai Medical Center
name: Case Western Reserve University
name: Columbia University
name: ChristianaCare
name: Indiana University
name: University of Pittsburgh
name: University of California, Irvine
name: University of Utah
name: University of Pennsylvania
name: Intermountain Health Care, Inc.
name: Eastern Virginia Medical School
name: University of Michigan
name: West Virginia University
First posted: 2022-07-25
Enrollment: 4048
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of hypertension (130/80 mmHg)
timeFrame: Assessed during the HHS2 in-person visit, 8-16 years after the index pregnancy.
measure: Incidence of diabetes
timeFrame: Assessed during the HHS2 in-person visit, 8-16 years after the index pregnancy.
measure: Incidence of obesity
timeFrame: Assessed during the HHS2 in-person visit, 8-16 years after the index pregnancy.
measure: Incidence of metabolic syndrome
timeFrame: Assessed during the HHS2 in-person visit, 8-16 years after the index pregnancy.
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Cleveland
country: United States
facility: The MetroHealth System
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Magee Womens Hospital
state: Pennsylvania
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Ogden
country: United States
facility: McKay-Dee Hospital
state: Utah
city: Provo
country: United States
facility: Utah Valley Hospital
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Salt Lake City
country: United States
facility: LDS Hospital
state: Utah
Study officials:
affiliation: Eastern Virginia Medical School
name: George Saade, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Phillip Greenland, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: RTI International
name: Rebecca McNeil, MD
role: PRINCIPAL_INVESTIGATOR
References: