CompletedNot Applicable

nuMoM2b Heart Health Study

United States4,509 participantsStarted 2014-09

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Interval Contact: * Agreed to contact for future studies during nuMoM2b and not subsequently withdrawn from the cohort.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 In-clinic Visit: * Consented for participation in interval contacts and not subsequently withdrawn * Between 2 and 3.5 years after the nuMoM2b pregnancy ended * Self-report at least 6 months postpartum from any subsequent pregnancy * Self-report not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 * Ab…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT02231398

SponsorRTI International

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-10-30

View on ClinicalTrials.gov More Pregnancy Complicated by Cardiovascular Disorders as Postpartum Condition, Delivered During Previous Episode trials