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Antihypertensive Treatment for Postpartum Hypertension (P-PAT Trial)
Phase 3
Recruiting
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with preeclampsia during pregnancy, labor or immediately postpartum
Age >= 18 years old
Must not have
Diagnosis of preeclampsia after discharge from delivery hospitalization
Persistent severe range blood pressures after delivery requiring initiation of antihypertensive regimen by the care team
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 6 weeks from delivery
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial will compare whether treating hypertension in the postpartum period decreases postpartum hypertension and its associated maternal morbidity.
Who is the study for?
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.
What is being tested?
The study compares the effects of starting antihypertensive drugs (Labetalol or Nifedipine) right after childbirth versus standard care on reducing high blood pressure and related health issues in women with recent preeclampsia.
What are the potential side effects?
Possible side effects from Labetalol may include fatigue, dizziness, and nausea. Nifedipine can cause swelling in the legs, flushing, and headaches. Each woman's experience with side effects may vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was diagnosed with preeclampsia during or right after my pregnancy.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I was diagnosed with preeclampsia after leaving the hospital from giving birth.
Select...
I started blood pressure medication after giving birth due to high readings.
Select...
I have long-term high blood pressure and now also have preeclampsia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 6 weeks from delivery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 6 weeks from delivery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Rate of Healthcare Utilization
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 Intervention
The patients randomized to the treatment group will have an antihypertensive medication prescribed to them. The specific medication will be either labetalol or nifedipine based on allergies and clinically appropriateness of the medication. The patient will be instructed on the dosing, timing, and possible adverse effects.
Group II: No-treatmentActive Control1 Intervention
Find a Location
Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
635 Previous Clinical Trials
1,181,402 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You gave birth within the last 96 hours.I was diagnosed with preeclampsia during or right after my pregnancy.More than 30% of your blood pressure readings after giving birth were high (systolic 140 or higher OR diastolic 90 or higher).I started blood pressure medication after giving birth due to high readings.I was diagnosed with preeclampsia after leaving the hospital from giving birth.I am 18 years old or older.I have long-term high blood pressure and now also have preeclampsia.More than half of the blood pressure readings after giving birth were within the normal range (systolic less than 140 AND diastolic less than 90).
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
- Group 2: No-treatment
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.