ClinicalTrials.gov
ClinicalTrials.gov Menu

nuMoM2b Heart Health Study (nuMoM2b-HHS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02231398
Recruitment Status : Active, not recruiting
First Posted : September 4, 2014
Last Update Posted : May 21, 2018
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Corette Parker, RTI International

Brief Summary:
This study is looking at the relationship between experiences during pregnancy and cardiovascular health 2 to 3½ years later. The investigators are recruiting women from the approximately 10,000 women who were enrolled and followed over the course of their first pregnancy in another study.

Condition or disease
Pregnancy Complicated by Cardiovascular Disorders as Postpartum Condition, Delivered During Previous Episode Breathing-Related Sleep Disorder

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 4509 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pregnancy as a Window to Future Cardiovascular Health: Adverse Pregnancy Outcomes as Predictors of Increased Risk Factors for Cardiovascular Disease
Study Start Date : September 2014
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 30, 2019

Group/Cohort
Women who participated in nuMoM2b



Primary Outcome Measures :
  1. Hypertension, defined as systolic blood pressure above 140 mm Hg or diastolic blood pressure above 90 mm Hg [ Time Frame: Blood pressures taken at study clinic visit between 2 and 3.5 years postpartum ]
    Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.


Secondary Outcome Measures :
  1. Systolic blood pressure in mm Hg [ Time Frame: Blood pressures taken at study clinic visit between 2 and 3.5 years postpartum ]
    Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.

  2. Diastolic blood pressures in mm Hg [ Time Frame: Blood pressures taken at study clinic visit between 2 and 3.5 years postpartum ]
    Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.

  3. HDL cholesterol in mg/dL from blood sample following overnight fast of at least 8 hours [ Time Frame: Blood sample taken at study clinic visit between 2 and 3.5 years postpartum ]
    Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.

  4. LDL cholesterol in mg/dL from blood sample following overnight fast of at least 8 hours [ Time Frame: Blood sample taken at study clinic visit between 2 and 3.5 years postpartum ]
    Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.

  5. Triglycerides in mg/dL from blood sample following overnight fast of at least 8 hours [ Time Frame: Blood sample taken at study clinic visit between 2 and 3.5 years postpartum ]
    Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.

  6. Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from glucose and insulin measured from blood sample following overnight fast of at least 8 hours [ Time Frame: Blood sample taken at study clinic visit between 2 and 3.5 years postpartum ]
    Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.

  7. High sensitivity C-reactive protein (hs-CRP) in mg/L measured from blood sample following overnight fast of at least 8 hours [ Time Frame: Taken at study clinic visit between 2 and 3.5 years postpartum ]
    Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.

  8. Hemoglobin A1c (%) measured from blood sample following overnight fast of at least 8 hours [ Time Frame: Taken at study clinic visit between 2 and 3.5 years postpartum ]
    Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.

  9. Sleep disordered breathing, defined as apnea-hypopnea index (AHI) of 3 or more [ Time Frame: Taken at study clinic visit between 2 and 3.5 years postpartum ]
    AHI calculated for apnea-hypopnea events with 3% desaturation.


Other Outcome Measures:
  1. N-terminal of the Prohormone Brain Natriuretic peptide (NT-proBNP) in pg/mL from blood sample following overnight fast of at least 8 hours [ Time Frame: Blood sample taken at study clinic visit between 2 and 3.5 years postpartum ]
    project funds permitting


Biospecimen Retention:   Samples With DNA

Blood Samples: A research or clinical staff member collects a fasting blood draw from the participant: 2 SST (tiger top) 10 mL tubes for serum; 2 EDTA (purple top) 10 mL tubes for plasma, and 1 (light blue top) 2.7 mL tube for citrated plasma. Less than 3 tablespoons of blood are collected. A 0.5 mL aliquot of whole blood from the EDTA tube is reserved. The rest of the blood is processed and as many 0.5 mL aliquots of serum, EDTA plasma, and citrated plasma as possible are collected. In addition, a 1.5 mL aliquot of buffy coat is collected from one of the EDTA tubes.

Urine Sample: A research or clinical staff member collects about 20 mL of clean catch urine from the participant and 2 urine aliquots (1.8 mL each).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligible women are recruited from the cohort enrolled to nuMoM2b. For nuMom2b a convenience sample was recruited through 8 primary clinical sites that NIH selected because they could each demonstrate access to more than 4,500 deliveries per year. As a group, sites were geographically dispersed and ethically diverse. All nulliparous women aged 13 years or greater with a singleton pregnancy less than 13 weeks 6 days gestation who presented at recruitment clinics or practices and planned to deliver at a study hospital were potentially eligible for participation. A clinical or research ultrasound, performed by a study certified sonographer, confirmed viability of a singleton gestation with no obvious malformations and estimated gestational age less than or equal to 13 weeks 6 days before the woman was allowed enrollment. The first visit was scheduled and completed within a window of 6 weeks 0 days and 13 weeks 6 days estimated gestational age.
Criteria

Inclusion Criteria:

Interval Contact:

  • Agreed to contact for future studies during nuMoM2b and not subsequently withdrawn from the cohort.
  • Have pregnancy outcome data from the nuMoM2b study.
  • At least 18 years of age (to begin interval contact attempts once nuMoM2b participant reaches age 18).
  • Provision of verbal consent for telephone interview or acknowledgement of consent with completion of the web-based self-administered questionnaire.

In-clinic Visit:

  • Consented for participation in interval contacts and not subsequently withdrawn
  • Between 2 and 3.5 years after the nuMoM2b pregnancy ended
  • Self-report at least 6 months postpartum from any subsequent pregnancy
  • Self-report not currently pregnant
  • Able to provide informed consent
  • Provision of written, signed, informed consent for the 2 to 3.5 year in-clinic assessment
  • Not currently pregnant by urine pregnancy test administered in the clinic following consent

In-home Sleep Breathing Assessment after the In-Clinic Visit:

  • Participation in the in-clinic visit
  • Participation in the sleep breathing substudy of nuMoM2b with at least one sleep breathing assessment providing valid data
  • Not currently using positive airway pressure (PAP) therapy or other approved treatments for sleep apnea such as oral appliances and nasal therapy patch (Provent)
  • Not currently on continuous oral steroid therapy for 14 days or more to treat asthma
  • Not currently using oxygen supplementation to treat a medical condition
  • Able to provide informed consent and deemed likely to return equipment in a reasonable period
  • Provision of written, signed, informed consent for the sleep breathing assessment for the nuMoM2b Heart Health Study

Exclusion Criteria:

  • Inability or refusal to provide informed consent for the study component.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02231398


Locations
United States, California
Fountain Valley Regional Hospital and Medical Center- UCI MFM private practice
Fountain Valley, California, United States, 92708
Long Beach Memorial Medical Center, Women's and Children's Hospital - Women's Perinatal Group, OB Clinic
Long Beach, California, United States, 90801
University of California, Irvine, Medical Center - Prenatal care clinics and private practice
Orange, California, United States, 92868
United States, Delaware
Christiana Care Health Systems
Newark, Delaware, United States, 19718
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Indiana
Indiana University School of Medicine OB/GYN
Indianapolis, Indiana, United States, 46202
United States, New York
Columbia University Medical Center- Department of OB/GYN Division of Maternal Fetal Medicine
New York, New York, United States, 10032
United States, Ohio
Case Western Reserve University, MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
United States, Utah
McKay Dee Hospital
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center
Provo, Utah, United States, 84604
University of Utah
Salt Lake City, Utah, United States, 84106
Intermountain Medical Center
Salt Lake City, Utah, United States, 84107
LDS Hospital
Salt Lake City, Utah, United States, 84143
Sponsors and Collaborators
RTI International
National Heart, Lung, and Blood Institute (NHLBI)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Study Chair: George Saade, M.D. University of Texas Medical Branch at Galveston
Principal Investigator: Brian M. Mercer, MD Case Western Reserve University
Principal Investigator: Ronald Wapner, MD Columbia University
Principal Investigator: David M. Haas, M.D., M.S., Indiana University
Principal Investigator: Hyagriv N. Simhan, MD, MSCR Magee Womens Hospital - University of Pittsburgh
Principal Investigator: William Grobman, M.D., M.B.A. Northwestern University
Principal Investigator: Judith Chung, M.D. University CA Irvine
Principal Investigator: Samuel Parry, M.D. University of Pennsylvania
Principal Investigator: Robert M. Silver, M.D. University of Utah

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Corette Parker, Principal Investigator of DCAC, RTI International
ClinicalTrials.gov Identifier: NCT02231398     History of Changes
Other Study ID Numbers: NHLBI-nuMoM2b-HHS-001
1U10HL119991 ( U.S. NIH Grant/Contract )
First Posted: September 4, 2014    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be made available through an NIH data repository.

Keywords provided by Corette Parker, RTI International:
Cardiovascular disease
Pregnant women
Nulliparity
Pregnancy outcomes
Pregnancy complications
Sleep disordered breathing

Additional relevant MeSH terms:
Disease
Cardiovascular Diseases
Respiratory Aspiration
Sleep Wake Disorders
Parasomnias
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders