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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 below

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I was diagnosed with preeclampsia during or right after my pregnancy.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I was diagnosed with preeclampsia after leaving the hospital from giving birth.

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I started blood pressure medication after giving birth due to high readings.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 6 weeks from delivery for reporting.

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

0 / 5Eligibility criteria met