Cardiovascular DiseasesnuMoM2b-HHS2NCT05472597
Continuation of the nuMoM2b Heart Health Study
An observational study of Cardiovascular Diseases, run by RTI International at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 4,048 participants
- Where
- 14 sitesUnited States
- Study dates
- 29 Nov 2022to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Current pregnancy.
- Withdrawal from study.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites
Northwestern University
Chicago, Illinois, 60611
Case Western Reserve University/The MetroHealth System
Cleveland, Ohio, 44109
Indiana University
Indianapolis, Indiana, 46202
Intermountain Medical Center
Murray, Utah, 84107
Columbia University Medical Center
New York, New York, 10032
Christiana Care Health Services
Newark, Delaware, 19718
McKay-Dee Hospital
Ogden, Utah, 84403
University of California, Irvine Medical Center
Orange, California, 92868
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
Magee Womens Research Institute
Pittsburgh, Pennsylvania, 15213
Utah Valley Hospital
Provo, Utah, 84604
University of Utah
Salt Lake City, Utah, 84132
LDS Hospital
Salt Lake City, Utah, 84143
About this study
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.
Read the 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).
- Conditions
- Cardiovascular Diseases
- Keywords
- Cardiovascular Diseases, Adverse Pregnancy Outcomes, Stillbirth, Small for Gestational Age, Preterm Birth, Hypertensive Diseases of Pregnancy, Gestational Diabetes
- Medical subject headings
- Cardiovascular Diseases, Stillbirth, Premature Birth, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 prospectively collected thereafter. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypertension (130/80 mmHg)
Measured blood pressure > 130/80 mmHg, use of antihypertensive medication, or self-report of a hypertension clinical diagnosis
Measured: 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
Measured: Assessed during the HHS2 in-person visit, 8-16 years after the index pregnancy.
Incidence of obesity
Measured BMI GE 30 kg/m^2
Measured: 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.
Measured: Assessed during the HHS2 in-person visit, 8-16 years after the index pregnancy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start29 Nov 2022
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,048 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Principal investigator, Becky McNeil, RTI International
- Investigators
- George Saade, MD, Principal investigator, Old Dominion UniversityPhillip Greenland, MD, Principal investigator, Northwestern UniversityRebecca McNeil, PhD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472597
- Sponsor's protocol ID
- 00047665
- Other IDs
- U01HL145358
- Acronym
- nuMoM2b-HHS2
- Status last verified
- Jun 2026
- First submitted
- 7 Jul 2022
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be made available through an NIH data repository.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuation of the nuMoM2b Heart Health Study
- ClinicalTrials.gov ID
- NCT05472597
- Acronym / sponsor ID
- nuMoM2b-HHS2 / 00047665
- Conditions
- Cardiovascular Diseases
- Keywords
- Cardiovascular Diseases, Adverse Pregnancy Outcomes, Stillbirth, Small for Gestational Age, Preterm Birth, Hypertensive Diseases of Pregnancy, Gestational Diabetes
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 4,048 participants (estimated)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- 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 start
- 29 Nov 2022 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 prospectively collected thereafter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Current pregnancy.
- Withdrawal from study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of hypertension (130/80 mmHg)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: Yes. Deidentified data will be made available through an NIH data repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
George Saade, MD principal investigator
Old Dominion University
Phillip Greenland, MD principal investigator
Northwestern University
Rebecca McNeil, PhD principal investigator
RTI International
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by RTI International at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypertension (130/80 mmHg) (time frame: Assessed during the HHS2 in-person visit, 8-16 years after the index pregnancy.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.