Comprehensive management program for postpartum women with hypertension
Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy: A Randomized Controlled
NA · Vanderbilt University Medical Center · NCT05849103
This study is testing a new program to help new moms with high blood pressure after pregnancy to see if it can lower their health risks and improve their care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Vanderbilt University Medical Center (other) |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT05849103 on ClinicalTrials.gov |
What this trial studies
This program focuses on postpartum patients with hypertensive disorders of pregnancy (HDP) to reduce severe maternal morbidity and mortality. It includes self-monitoring of blood pressure through an app, management support from a program navigator, and coordinated care transitions to primary care clinicians. The study will randomize 300 patients starting on postpartum day one and follow them for three months, assessing various outcomes related to blood pressure control and maternal health. The primary outcome is blood pressure reporting at 7-10 days postpartum, with secondary outcomes including severe maternal morbidity and healthcare visit attendance.
Who should consider this trial
Good fit: Ideal candidates are women over 18 years old diagnosed with a hypertensive disorder of pregnancy.
Not a fit: Patients who are non-English speaking or have contraindications to hypertension control may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve blood pressure management and reduce maternal health risks for postpartum women with hypertensive disorders.
How similar studies have performed: Other studies have shown promise in using telemedicine and peer navigation for improving postpartum care, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 1. Age \>18 years 2. Diagnosed with a Hypertensive Disorder of Pregnancy (HDP), which includes chronic hypertension, preeclampsia, gestational hypertension, HELLP Syndrome (Hemolysis, Elevated Liver enzymes, Low Platelets), or eclampsia (O10, O11, O13, O14, O15, O16) Exclusion Criteria 1. Not able or willing to receive electronic surveys 2. Deemed inappropriate for study enrollment by the bedside nurse 3. Non-English speaking 4. Contraindication to ACOG-recommended hypertension control (i.e. chronic kidney disease, stroke)
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (RECRUITING)
Study contacts
- Principal investigator: Sarah Osmundson, MD — Associate Professor Maternal-Fetal Medicine
- Study coordinator: Sarah Osmundson, MD
- Email: sarah.osmundson@vumc.org
- Phone: 615-343-5700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypertension, Pregnancy-Induced, Postpartum Preeclampsia, Hypertension, Maternal, Postpartum hypertension