Status:
COMPLETED
nuMoM2b Heart Health Study
Lead Sponsor:
RTI International
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Pregnancy Complicated by Cardiovascular Disorders as Postpartum Condition, Delivered During Previous Episode
Breathing-Related Sleep Disorder
Eligibility:
FEMALE
18+ years
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...
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...
Eligibility Criteria
Inclusion
- 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- Agreed to contact for future studies during nuMoM2b and not subsequently withdrawn from the cohort.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- Consented for participation in interval contacts and not subsequently withdrawn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
- Inability or refusal to provide informed consent for the study component.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 30 2020
Estimated Enrollment :
4509 Patients enrolled
Trial Details
Trial ID
NCT02231398
Start Date
September 1 2014
End Date
October 30 2020
Last Update
February 16 2022
Active Locations (15)
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1
Fountain Valley Regional Hospital and Medical Center- UCI MFM private practice
Fountain Valley, California, United States, 92708
2
Long Beach Memorial Medical Center, Women's and Children's Hospital - Women's Perinatal Group, OB Clinic
Long Beach, California, United States, 90801
3
University of California, Irvine, Medical Center - Prenatal care clinics and private practice
Orange, California, United States, 92868
4
Christiana Care Health Systems
Newark, Delaware, United States, 19718