nuMoM2b Heart Health Study

Completed

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

In brief

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.

Key facts

Study ID

NCT02231398

Run by

RTI International

People needed

4509

Starts

2014-09-01

Expected to finish

2020-10-30

Last updated by the study team

2022-02-16

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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• Agreed to contact for future studies during nuMoM2b and not subsequently withdrawn from the cohort.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• Consented for participation in interval contacts and not subsequently withdrawn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
• 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

You may not qualify if…

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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