nuMoM2b Heart Health Study

Breathing-Related Sleep Disorder Clinical Trial

— nuMoM2b-HHS  

Official title:

Pregnancy as a Window to Future Cardiovascular Health: Adverse Pregnancy Outcomes as Predictors of Increased Risk Factors for Cardiovascular Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02231398
• Other study ID #: NHLBI-nuMoM2b-HHS-001
• Secondary ID: 1U10HL119991
• Status: Completed
• Start date: September 2014
• Est. completion date: October 30, 2020

Study information

• Verified date: January 2022
• Source: RTI International
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4509
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breathing-Related Sleep Disorder
• Cardiovascular Diseases
• Disease
• Pregnancy Complicated by Cardiovascular Disorders as Postpartum Condition, Delivered During Previous Episode
• Respiratory Aspiration
• Sleep Wake Disorders

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	Case Western Reserve University, MetroHealth Medical Center	Cleveland	Ohio
United States	Fountain Valley Regional Hospital and Medical Center- UCI MFM private practice	Fountain Valley	California
United States	Indiana University School of Medicine OB/GYN	Indianapolis	Indiana
United States	Long Beach Memorial Medical Center, Women's and Children's Hospital - Women's Perinatal Group, OB Clinic	Long Beach	California
United States	Columbia University Medical Center- Department of OB/GYN Division of Maternal Fetal Medicine	New York	New York
United States	Christiana Care Health Systems	Newark	Delaware
United States	McKay Dee Hospital	Ogden	Utah
United States	University of California, Irvine, Medical Center - Prenatal care clinics and private practice	Orange	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Magee Womens Hospital	Pittsburgh	Pennsylvania
United States	Utah Valley Regional Medical Center	Provo	Utah
United States	Intermountain Medical Center	Salt Lake City	Utah
United States	LDS Hospital	Salt Lake City	Utah
United States	University of Utah	Salt Lake City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
RTI International	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	N-terminal of the Prohormone Brain Natriuretic peptide (NT-proBNP) in pg/mL from blood sample following overnight fast of at least 8 hours	project funds permitting	Blood sample taken at study clinic visit between 2 and 3.5 years postpartum
Primary	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	Systolic blood pressure in 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	Diastolic blood pressures in 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	HDL cholesterol in mg/dL from blood sample following overnight fast of at least 8 hours	Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.	Blood sample taken at study clinic visit between 2 and 3.5 years postpartum
Secondary	LDL cholesterol in mg/dL from blood sample following overnight fast of at least 8 hours	Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.	Blood sample taken at study clinic visit between 2 and 3.5 years postpartum
Secondary	Triglycerides in mg/dL from blood sample following overnight fast of at least 8 hours	Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.	Blood sample taken at study clinic visit between 2 and 3.5 years postpartum
Secondary	Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from glucose and insulin measured from blood sample following overnight fast of at least 8 hours	Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.	Blood sample taken at study clinic visit between 2 and 3.5 years postpartum
Secondary	High sensitivity C-reactive protein (hs-CRP) in mg/L measured from blood sample following overnight fast of at least 8 hours	Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.	Taken at study clinic visit between 2 and 3.5 years postpartum
Secondary	Hemoglobin A1c (%) measured from blood sample following overnight fast of at least 8 hours	Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.	Taken at study clinic visit between 2 and 3.5 years postpartum
Secondary	Sleep disordered breathing, defined as apnea-hypopnea index (AHI) of 3 or more	AHI calculated for apnea-hypopnea events with 3% desaturation.	Taken at study clinic visit between 2 and 3.5 years postpartum