nuMoM2b Heart Health Study

NCT ID: NCT02231398

Last Updated: 2022-02-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4509 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2020-10-30

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.

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Women who participated in nuMoM2b

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

RTI International

OTHER

Sponsor Role: lead

Responsible Party

Becky McNeil

Senior Research Statistician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

George Saade, M.D.

Role: STUDY_CHAIR

University of Texas Medical Branch at Galveston

Brian M. Mercer, MD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Ronald Wapner, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

David M. Haas, M.D., M.S.,

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Hyagriv N. Simhan, MD, MSCR

Role: PRINCIPAL_INVESTIGATOR

Magee Womens Hospital - University of Pittsburgh

William Grobman, M.D., M.B.A.

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Judith Chung, M.D.

Role: PRINCIPAL_INVESTIGATOR

University CA Irvine

Samuel Parry, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Robert M. Silver, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

Fountain Valley Regional Hospital and Medical Center- UCI MFM private practice

Fountain Valley, California, United States

Long Beach Memorial Medical Center, Women's and Children's Hospital - Women's Perinatal Group, OB Clinic

Long Beach, California, United States

University of California, Irvine, Medical Center - Prenatal care clinics and private practice

Orange, California, United States

Christiana Care Health Systems

Newark, Delaware, United States

Northwestern University

Chicago, Illinois, United States

Indiana University School of Medicine OB/GYN

Indianapolis, Indiana, United States

Columbia University Medical Center- Department of OB/GYN Division of Maternal Fetal Medicine

New York, New York, United States

Case Western Reserve University, MetroHealth Medical Center

Cleveland, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Magee Womens Hospital

Pittsburgh, Pennsylvania, United States

McKay Dee Hospital

Ogden, Utah, United States

Utah Valley Regional Medical Center

Provo, Utah, United States

University of Utah

Salt Lake City, Utah, United States

Intermountain Medical Center

Salt Lake City, Utah, United States

LDS Hospital

Salt Lake City, Utah, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 26825925 (View on PubMed)

Catov JM, Parker CB, Gibbs BB, Bann CM, Carper B, Silver RM, Simhan HN, Parry S, Chung JH, Haas DM, Wapner RJ, Saade GR, Mercer BM, Bairey-Merz CN, Greenland P, Ehrenthal DB, Barnes SE, Shanks AL, Reddy UM, Grobman WA; NICHD NuMoM2b and NHLBI NuMoM2b Heart Health Study Network. Patterns of leisure-time physical activity across pregnancy and adverse pregnancy outcomes. Int J Behav Nutr Phys Act. 2018 Jul 11;15(1):68. doi: 10.1186/s12966-018-0701-5.

Reference Type: BACKGROUND

PMID: 29996930 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 30518449 (View on PubMed)

Haas DM, Yang Z, Parker CB, Chung J, Parry S, Grobman WA, Mercer BM, Simhan HN, Silver RM, Wapner RJ, Saade GR, Greenland P, Merz NB, Reddy UM, Pemberton VL; nuMoM2b study and the nuMoM2b Heart Health Study. Factors associated with duration of breastfeeding in women giving birth for the first time. BMC Pregnancy Childbirth. 2022 Sep 22;22(1):722. doi: 10.1186/s12884-022-05038-7.

Reference Type: DERIVED

PMID: 36138368 (View on PubMed)

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Reference Type: DERIVED

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Reference Type: DERIVED

PMID: 33756281 (View on PubMed)

Catov JM, McNeil RB, Marsh DJ, Mercer BM, Bairey Merz CN, Parker CB, Pemberton VL, Saade GR, Chen YI, Chung JH, Ehrenthal DB, Grobman WA, Haas DM, Parry S, Polito L, Reddy UM, Silver RM, Simhan HN, Wapner RJ, Kominiarek M, Kreutz R, Levine LD, Greenland P; NHLBI nuMoM2b Heart Health Study. Early Pregnancy Atherogenic Profile in a First Pregnancy and Hypertension Risk 2 to 7 Years After Delivery. J Am Heart Assoc. 2021 Feb;10(5):e017216. doi: 10.1161/JAHA.120.017216. Epub 2021 Feb 23.

Reference Type: DERIVED

PMID: 33619977 (View on PubMed)

Haas DM, Parker CB, Marsh DJ, Grobman WA, Ehrenthal DB, Greenland P, Bairey Merz CN, Pemberton VL, Silver RM, Barnes S, McNeil RB, Cleary K, Reddy UM, Chung JH, Parry S, Theilen LH, Blumenthal EA, Levine LD, Mercer BM, Simhan H, Polito L, Wapner RJ, Catov J, Chen I, Saade GR; NHLBI nuMoM2b Heart Health Study. Association of Adverse Pregnancy Outcomes With Hypertension 2 to 7 Years Postpartum. J Am Heart Assoc. 2019 Oct;8(19):e013092. doi: 10.1161/JAHA.119.013092. Epub 2019 Sep 30.

Reference Type: DERIVED

PMID: 31564189 (View on PubMed)

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Reference Type: DERIVED

PMID: 31256258 (View on PubMed)

Other Identifiers

1U10HL119991

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NHLBI-nuMoM2b-HHS-001

Identifier Type: -

Identifier Source: org_study_id