Antihypertensive Treatment for Postpartum Hypertension
(P-PAT Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.
What data supports the effectiveness of the drugs Labetalol and Nifedipine for treating postpartum hypertension?
Research shows that both Labetalol and Nifedipine effectively control blood pressure in pregnant women with chronic hypertension, with similar outcomes in mean blood pressure levels. Additionally, Labetalol may offer a slight advantage in reducing diastolic blood pressure in non-black women compared to Nifedipine.12345
Is the treatment for postpartum hypertension safe?
Labetalol and nifedipine are considered safe for use in pregnancy and postpartum hypertension, as they have been studied for managing high blood pressure in pregnant women. These medications are generally well-tolerated and are commonly used to control severe hypertension during and after pregnancy.24567
How does the drug Labetalol differ from Nifedipine for postpartum hypertension?
Labetalol and Nifedipine are both used to manage postpartum hypertension, but they work differently. Labetalol is a beta-blocker that helps slow the heart rate, while Nifedipine is a calcium channel blocker that relaxes blood vessels. Studies suggest that Nifedipine may control blood pressure faster, but Labetalol might be needed less often after discharge.3891011
What is the purpose of this trial?
The goal of this study is to compare whether antihypertensive treatment in the postpartum period decreases postpartum hypertension and its associated maternal morbidity, including risk of readmission and healthcare utilization in comparison with no treatment. Women with preeclampsia diagnosed during the antepartum, intrapartum or postpartum period will be randomized to either initiate antihypertensive treatment or standard of care. We hypothesize that postpartum antihypertensive treatment of patients with preeclampsia will decrease risk of hospital readmission, healthcare utilization and the number of severe range blood pressures at postpartum follow-up visits.
Eligibility Criteria
This trial is for women over 18 who were diagnosed with preeclampsia during or immediately after pregnancy and have high blood pressure postpartum. It's not for those with chronic hypertension, a late diagnosis of preeclampsia, or mostly normal blood pressures after delivery.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive antihypertensive medication postpartum, with specific medication prescribed based on allergies and clinical appropriateness
Follow-up
Participants are monitored for safety and effectiveness after treatment, including blood pressure checks and postpartum assessments
Treatment Details
Interventions
- Labetalol
- Nifedipine
Labetalol is already approved in European Union, United States, Canada, Japan for the following indications:
- Hypertension
- Preeclampsia
- Hypertension
- Preeclampsia
- Hypertension
- Preeclampsia
- Hypertension
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical College of Wisconsin
Lead Sponsor