Controlling blood pressure after preeclampsia to improve heart health
Reducing the Risk of Chronic Hypertension and Improving Vascular Function Following Preeclampsia
This study is testing if closely managing blood pressure after giving birth can help women who had high blood pressure during pregnancy improve their heart health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 618 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Medical College of Wisconsin Academic / other |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT06220721 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effects of intensive postpartum blood pressure control on cardiovascular health in women who experienced hypertensive disorders during pregnancy. A total of 618 postpartum patients will be randomly assigned to receive either intensive blood pressure management or usual care in the first six weeks after delivery. The intervention involves initiating nifedipine extended-release for those with elevated blood pressure, while the control group will start treatment at a higher threshold. Participants will undergo various cardiovascular assessments and biomarker collections at baseline, six weeks, and twelve months postpartum to determine the impact on hypertension and vascular function.
Who should consider this trial
Good fit: Ideal candidates are postpartum women aged 18 and older who have been diagnosed with hypertensive disorders of pregnancy.
Not a fit: Patients with pre-gestational hypertension or other significant maternal health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of chronic hypertension and improve long-term cardiovascular health in women post-preeclampsia.
How similar studies have performed: Other studies have shown promise in managing postpartum hypertension, but this specific approach is novel in its intensive management strategy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Hypertensive disorders of pregnancy (HDP) diagnosis, specifically gestational hypertension, preeclampsia, eclampsia, or HELLP syndrome, according to ACOG guidelines * Postpartum day 0-4 * Age ≥ 18 years * Able to communicate in English or in Spanish * Has an established OBGYN at an MCW or NU health system practice that has access to Epic electronic medical records. Exclusion Criteria: * Pre-gestational hypertension * Type 1 or type 2 diabetes mellitus * Admitted to intensive care unit at the time of screening * Diagnosed with HDP during postpartum readmission after discharge from delivery hospitalization * Getting discharged on the day of screening * Known allergy or contraindication to nifedipine ER * Inability or unwillingness to provide informed consent * Already taking long-acting antihypertensive medication for standard care * Maternal conditions that impact study outcomes: sickle cell disease, systemic lupus erythematosus
Where this trial is running
Chicago, Illinois and 1 other locations
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Anna Palatnik, MD — Medical College of Wisconsin
- Study coordinator: Alyssa M Hernandez, DO
- Email: alyhernandez@mcw.edu
- Phone: 4148055285
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.