nuMoM2b Heart Health Study

NCT02231398 | Completed DMC

• 2 other identifiers: NHLBI-nuMoM2b-HHS-0011U10HL119991
• Study Type: observational
• Target: 4,509
• Locations: 1 country
• Sites: 15

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.

Conditions

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

Keywords

Cardiovascular disease; Pregnant women; Nulliparity; Pregnancy outcomes; Pregnancy complications; Sleep disordered breathing

Outcome Measures

Primary Outcomes (1)

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

  Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.

  Blood pressures taken at study clinic visit between 2 and 3.5 years postpartum

Secondary Outcomes (9)

• Systolic blood pressure in mm Hg

  Blood pressures taken at study clinic visit between 2 and 3.5 years postpartum

• Diastolic blood pressures in mm Hg

  Blood pressures taken at study clinic visit between 2 and 3.5 years postpartum

• 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

• 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

• 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

Other Outcomes (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

  Blood sample taken at study clinic visit between 2 and 3.5 years postpartum

Study Arms (1)

Women who participated in nuMoM2b

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• RTI International: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (15)

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

Fountain Valley, California, 92708, United States

Location

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

Long Beach, California, 90801, United States

Location

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

Orange, California, 92868, United States

Location

Christiana Care Health Systems

Newark, Delaware, 19718, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Indiana University School of Medicine OB/GYN

Indianapolis, Indiana, 46202, United States

Location

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

New York, New York, 10032, United States

Location

Case Western Reserve University, MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

McKay Dee Hospital

Ogden, Utah, 84403, United States

Location

Utah Valley Regional Medical Center

Provo, Utah, 84604, United States

Location

University of Utah

Salt Lake City, Utah, 84106, United States

Location

Intermountain Medical Center

Salt Lake City, Utah, 84107, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Related Publications (9)

• Haas DM, Ehrenthal DB, Koch MA, Catov JM, Barnes SE, Facco F, Parker CB, Mercer BM, Bairey-Merz CN, Silver RM, Wapner RJ, Simhan HN, Hoffman MK, Grobman WA, Greenland P, Wing DA, Saade GR, Parry S, Zee PC, Reddy UM, Pemberton VL, Burwen DR; National Heart, Lung, and Blood Institute nuMoM2b Heart Health Study Network. Pregnancy as a Window to Future Cardiovascular Health: Design and Implementation of the nuMoM2b Heart Health Study. Am J Epidemiol. 2016 Mar 15;183(6):519-30. doi: 10.1093/aje/kwv309. Epub 2016 Jan 28.

  PMID: 26825925 BACKGROUND

• 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.

  PMID: 29996930 BACKGROUND

• Facco FL, Parker CB, Hunter S, Reid KJ, Zee PC, Silver RM, Haas DM, Chung JH, Pien GW, Nhan-Chang CL, Simhan HN, Parry S, Wapner RJ, Saade GR, Mercer BM, Torres C, Knight J, Reddy UM, Grobman WA; NICHD NuMoM2b and NHLBI NuMoM2b Heart Health Study Networks. Association of Adverse Pregnancy Outcomes With Self-Reported Measures of Sleep Duration and Timing in Women Who Are Nulliparous. J Clin Sleep Med. 2018 Dec 15;14(12):2047-2056. doi: 10.5664/jcsm.7534.

  PMID: 30518449 BACKGROUND

• 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.

  PMID: 36138368 DERIVED

• Facco FL, Redline S, Hunter SM, Zee PC, Grobman WA, Silver RM, Louis JM, Pien GW, Mercer B, Chung JH, Bairey Merz CN, Haas DM, Nhan-Chang CL, Simhan HN, Schubert FP, Parry S, Reddy U, Saade GR, Hoffman MK, Levine LD, Wapner RJ, Catov JM, Parker CB. Sleep-disordered Breathing in Pregnancy and after Delivery: Associations with Cardiometabolic Health. Am J Respir Crit Care Med. 2022 May 15;205(10):1202-1213. doi: 10.1164/rccm.202104-0971OC.

  PMID: 35144521 DERIVED

• Hawkins M, Parker CB, Redline S, Larkin JC, Zee PP, Grobman WA, Silver RM, Louis JM, Pien GW, Basner RC, Chung JH, Haas DM, Nhan-Chang CL, Simhan HN, Blue NR, Parry S, Reddy U, Facco F; NICHD NuMoM2b and NHLBI NuMoM2b Heart Health Study Networks. Objectively assessed sleep-disordered breathing during pregnancy and infant birthweight. Sleep Med. 2021 May;81:312-318. doi: 10.1016/j.sleep.2021.02.043. Epub 2021 Feb 27.

  PMID: 33756281 DERIVED

• 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.

  PMID: 33619977 DERIVED

• 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.

  PMID: 31564189 DERIVED

• Monk C, Webster RS, McNeil RB, Parker CB, Catov JM, Greenland P, Bairey Merz CN, Silver RM, Simhan HN, Ehrenthal DB, Chung JH, Haas DM, Mercer BM, Parry S, Polito L, Reddy UM, Saade GR, Grobman WA; NICHD nuMoM2b and NHLBI nuMoM2b Heart Health Study Networks. Associations of perceived prenatal stress and adverse pregnancy outcomes with perceived stress years after delivery. Arch Womens Ment Health. 2020 Jun;23(3):361-369. doi: 10.1007/s00737-019-00970-8. Epub 2019 Jun 29.

  PMID: 31256258 DERIVED

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).

MeSH Terms

Conditions

Cardiovascular Diseases; Pregnancy Complications; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• George Saade, M.D.

  The University of Texas Medical Branch, Galveston

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Statistician

Study Record Dates

• First Submitted: August 28, 2014
• First Posted: September 4, 2014
• Study Start: September 1, 2014
• Primary Completion: October 30, 2017
• Study Completion: October 30, 2020
• Last Updated: February 16, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share

Locations

US (15)