nuMoM2b-HHS: nuMoM2b Heart Health Study

Sponsor

RTI International (Other)

Overall Status

Completed

CT.gov ID

NCT02231398

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

4,509

Enrollment

Locations

Duration (Months)

300.6

Patients Per Site

4.1

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Pregnancy Complicated by Cardiovascular Disorders as Postpartum Condition, Delivered During Previous Episode Breathing-Related Sleep Disorder

Detailed Description

The National Heart, Lung, and Blood Institute (NHLBI), in collaboration with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, is funding this follow-up study of the nuMoM2b cohort to evaluate the association between adverse pregnancy outcomes (APOs) and cardiovascular health approximately 2 to 3½ years postpartum. The study, called the nuMoM2b Heart Health Study or nuMoM2b HHS, utilizes the extensive database and tissue bank developed for nuMoM2b in which nulliparous women are evaluated over the course of pregnancy to study the mechanisms for and prediction of APOs. Women enrolled in the nuMoM2b cohort are extremely well phenotyped through prospective data collection, clinical evaluations, and ultrasound assessments, as well as through the use of standardized definitions. Demographic, psychosocial, dietary, physiologic, and outcome information were collected through maternal interviews, self-administered questionnaires, clinical measurements, ultrasounds, and medical record abstraction. Samples of maternal blood, urine, and cervico-vaginal fluid over pregnancy and cord blood and placenta at delivery were collected and banked. All women completed two sleep questionnaires and over 3,600 had objective overnight sleep studies at two times during pregnancy.

Women participating in the nuMoM2b are assessed in nuMoM2b HHS for evidence of cardiovascular disease risk (CVDR), including sleep disordered breathing (SDB), at 2 to 3½ years postpartum. APOs in subsequent pregnancies also are assessed. This study characterizes the relationship between APOs and CVDR, identify first pregnancy profiles that portend subsequent CVDR, determine associations between SDB during the first pregnancy and subsequent CVDR, and identify modifiable factors that mediate the associations between CVDR and APOs in the first and subsequent pregnancy. This follow-up study will allow for the development of strategies to modify these CVDR factors and to improve the health of women suffering APOs.

The nuMoM2b Heart Health Study is a prospective observational study that includes interval contacts and a detailed cardiovascular assessment 2 to 3½ years after delivery of the index pregnancy. At the cardiovascular assessment, potentially eligible women are invited to attend a cardiovascular screening visit. After informed consent, a urine pregnancy test is performed to confirm eligibility. The visit includes clinical and laboratory measurements as well as a structured interview to assess domains that were measured in the nuMoM2b pregnancy: physical activity, depression, social support, psychological stress, and nutritional status. Women with sleep breathing assessments during their nuMoM2b pregnancy are offered another overnight sleep study.

The overarching goal is to better define the relation between outcomes of pregnancy and long term health of the mother. The specific aims are as follows:

Aim 1: Define the incidence of hypertension and the cardiovascular disease risk (CVDR) profile of women approximately 2 to 3½ years after a first pregnancy complicated by preeclampsia or other adverse pregnancy outcomes (APOs: stillbirth, small for gestational age at birth [SGA], preterm birth, preeclampsia, pregnancy-associated hypertension, gestational diabetes [GDM]) compared to women having no APOs in the first pregnancy.

Aim 2: Identify a profile in early pregnancy that portends subsequent CVDR approximately 2 to 3½ years postpartum.

Aim 3: Determine whether pregnancy and postpartum sleep disordered breathing (SDB) is associated with increased CVDR and identify specific patterns of pregnancy and postpartum SDB that increase CVDR.

Aim 4: Identify modifiable factors during and after pregnancy that mediate the associations between APOs and the CVDR during pregnancy and approximately 2 to 3½ years postpartum.

Study Design

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 :

Sep 1, 2014

Actual Primary Completion Date :

Oct 30, 2017

Actual Study Completion Date :

Oct 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Women who participated in nuMoM2b

Outcome Measures

Primary Outcome Measures

Hypertension, defined as systolic blood pressure above 140 mm Hg or diastolic blood pressure above 90 mm Hg [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

Systolic blood pressure in mm Hg [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.
Diastolic blood pressures in mm Hg [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.
HDL cholesterol in mg/dL from blood sample following overnight fast of at least 8 hours [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.
LDL cholesterol in mg/dL from blood sample following overnight fast of at least 8 hours [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.
Triglycerides in mg/dL from blood sample following overnight fast of at least 8 hours [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.
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from glucose and insulin measured from blood sample following overnight fast of at least 8 hours [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.
High sensitivity C-reactive protein (hs-CRP) in mg/L measured from blood sample following overnight fast of at least 8 hours [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.
Hemoglobin A1c (%) measured from blood sample following overnight fast of at least 8 hours [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.
Sleep disordered breathing, defined as apnea-hypopnea index (AHI) of 3 or more [Taken at study clinic visit between 2 and 3.5 years postpartum]
AHI calculated for apnea-hypopnea events with 3% desaturation.

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fountain Valley Regional Hospital and Medical Center- UCI MFM private practice	Fountain Valley	California	United States	92708
2	Long Beach Memorial Medical Center, Women's and Children's Hospital - Women's Perinatal Group, OB Clinic	Long Beach	California	United States	90801
3	University of California, Irvine, Medical Center - Prenatal care clinics and private practice	Orange	California	United States	92868
4	Christiana Care Health Systems	Newark	Delaware	United States	19718
5	Northwestern University	Chicago	Illinois	United States	60611
6	Indiana University School of Medicine OB/GYN	Indianapolis	Indiana	United States	46202
7	Columbia University Medical Center- Department of OB/GYN Division of Maternal Fetal Medicine	New York	New York	United States	10032
8	Case Western Reserve University, MetroHealth Medical Center	Cleveland	Ohio	United States	44109
9	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
10	Magee Womens Hospital	Pittsburgh	Pennsylvania	United States	15213
11	McKay Dee Hospital	Ogden	Utah	United States	84403
12	Utah Valley Regional Medical Center	Provo	Utah	United States	84604
13	University of Utah	Salt Lake City	Utah	United States	84106
14	Intermountain Medical Center	Salt Lake City	Utah	United States	84107
15	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