Active — Not RecruitingNot Applicable

Enhancing Care & Outcomes for Patients During the First Postpartum Year

United States100 participantsStarted 2024-11-12

Plain-language summary

The United States is in the midst of a maternal mortality and morbidity crisis, with more than half of maternal deaths occurring within the first postpartum year. Patients with hypertensive disorders of pregnancy (HDP) and diabetes have been found to be particularly high-risk, as they have a significantly increased risk for the development of cardiovascular disease in the long-term postpartum period. Traditionally, postpartum care has consisted of a single office visit at six weeks postpartum. Recent research has suggested that postpartum care should be an ongoing process, tailored to each woman's specifics needs. The purpose of this research study is to evaluate the effectiveness of obstetric care providers as primary care providers for patients at increased risk of maternal morbidity and mortality in the full first postpartum year.

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: * Age 18 or older * Pregnant individuals * Planning to deliver and continue postpartum care at the University of Maryland Medical Center * Diagnosis of HDP or diabetes (pre-gestational or gestational) before discharge from admission for delivery * Medicaid insurance coverage Exclusion Criteria: * Less than 18 years of age * Fetal demise * No diagnosis of HDP and/or diabetes (pre-gestational or gestational) * Non-Medicaid insurance coverage

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

Change in systolic blood pressure measurement from baseline

Timeframe: 6 weeks, 3, 6, and 12 months postpartum

Change in diastolic blood pressure measurement form baseline

Timeframe: 6 weeks, 3, 6, and 12 months postpartum

Change from baseline in blood glucose level measured by fingerstick

Timeframe: 6 weeks, 3, 6, and 12 months postpartum

Change in serum A1C level from baseline

Timeframe: 6 and 12 months postpartum

Trial details

NCT IDNCT06615076

SponsorUniversity of Maryland, Baltimore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01

View on ClinicalTrials.gov More Postpartum Period trials

Plain-language summary

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.

What they're measuring

Change in systolic blood pressure measurement from baseline

Timeframe: 6 weeks, 3, 6, and 12 months postpartum

Change in diastolic blood pressure measurement form baseline

Timeframe: 6 weeks, 3, 6, and 12 months postpartum

Change from baseline in blood glucose level measured by fingerstick

Timeframe: 6 weeks, 3, 6, and 12 months postpartum

Change in serum A1C level from baseline

Timeframe: 6 and 12 months postpartum