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Beta Blocker

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7-10 days postpartum
Awards & highlights

P-PAT 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.Check my eligibility
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.See study design
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.

P-PAT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was diagnosed with preeclampsia during or right after my pregnancy.
Select...
I am 18 years old or older.

P-PAT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7-10 days postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7-10 days postpartum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hospital Readmission
Secondary outcome measures
Rate of Healthcare Utilization
compare mean systolic and mean diastolic blood pressure values at 7-10 days postpartum and at 6weeks postpartum
percentage of severe range blood pressures at the 6 week postpartum visit
+1 more

P-PAT 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
609 Previous Clinical Trials
1,162,283 Total Patients Enrolled
16 Trials studying Hypertension
11,332 Patients Enrolled for Hypertension

Media Library

Labetalol (Beta Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT04298034 — Phase 3
Hypertension Research Study Groups: Treatment, No-treatment
Hypertension Clinical Trial 2023: Labetalol Highlights & Side Effects. Trial Name: NCT04298034 — Phase 3
Labetalol (Beta Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04298034 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can people with the qualifying condition still enroll in this trial?

"That is accurate. The clinical trial in question, as indicated by its listing on clinicaltrials.gov, is looking for volunteers. This particular study was first posted on 7/17/2020 and was updated on 11/24/2021; it hopes to enroll 300 people at 1 location."

Answered by AI

What conditions are Labetalol and Nifedipine generally prescribed for?

"Labetalol and nifedipine are most often given to patients with vasospastic angina, but the medication can also have other benefits for those with conditions like pheochromocytomas, high altitude sickness, and premature labor."

Answered by AI

What are the side effects of Labetalol, Nifedipine?

"Labetalol and nifedipine have been studied before and shown to be safe, so they received a score of 3."

Answered by AI

What other medical studies have included Labetalol and Nifedipine?

"As of right now, there are 19 ongoing clinical trials for Labetalol, Nifedipine. 3 of those active clinical trials are currently in Phase 3. Although the majority of trials for Labetalol, Nifedipine originate from Breckenridge, Colorado - with 94 locations running trials in total - across the United States of America."

Answered by AI

How many people have signed up to participate in this experiment?

"That is correct, as of now this study is still looking for patients. The earliest date that this information was posted was on July 17th, 2020 with the most recent update being on November 24th, 2021. They are searching for a total of 300 individuals across 1 location."

Answered by AI

Is this a new type of clinical trial?

"Labetalol, Nifedipine has been under research for over a decade. In 2007, Encysive Pharmaceuticals ran the first study and 27 participants. After review by an authoritative body, Labetalol, Nifedipine was approved for Phase 2 drug trials. Now, there are 19 live trials in 66 cities and 6 countries."

Answered by AI
~13 spots leftby Jun 2024