nuMoM2b Heart Health Study (nuMoM2b-HHS)

RTI International

Status: Completed

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

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02231398

NHLBI-nuMoM2b-HHS-001

1U10HL119991 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,509 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

4,509 participants in 1 patient group

Women who participated in nuMoM2b