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Beta Blocker

Labetalol vs Nifedipine for Postpartum Hypertension

Phase 4

Waitlist Available

Led By Whitney A. Booker, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

With a prior diagnosis of chronic hypertension (not on medication) or hypertensive disorder of pregnancy

Be older than 18 years old

Must not have

Patients with a known atrial-ventricular heart block or moderate to severe bronchial asthma will be excluded, or other contraindication to receiving either study medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 hours

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare the effectiveness of two blood pressure medications in women who have just given birth.

Who is the study for?

This trial is for women who have recently given birth (up to 6 weeks postpartum) and are experiencing severe high blood pressure. They may have had chronic hypertension or a hypertensive disorder during pregnancy. Women with heart block, severe asthma, or recent exposure to the study medications cannot participate.

What is being tested?

The study is comparing two treatments for high blood pressure in new mothers: intravenous labetalol versus oral nifedipine. It aims to determine which medication more effectively lowers dangerously high blood pressure after childbirth.

What are the potential side effects?

Labetalol might cause fatigue, dizziness, or nausea; it can also affect heart rate. Nifedipine could lead to swelling in the legs, flushing, headaches, and possible rapid heartbeat. Each person's reaction can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with chronic high blood pressure or had high blood pressure during pregnancy.

Exclusion Criteria

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

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I do not have severe asthma or heart block.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 48 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Average Time to Initial Blood Pressure Control (minutes)

Secondary study objectives

Average Number of Recurrence of Severe Blood Pressure

Total Number of Participants Who Need for Second Antihypertensive Agent

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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

Active Control

Group I: Oral NifedipineActive Control1 Intervention

Oral nifedipine: Once diagnosis of hypertensive emergency is confirmed on repeat blood pressure, patients randomized to oral nifedipine will receive 10mg initially, with repeated doses of 20mg every 20min, for up to a maximum of 5 doses or until the therapeutic blood pressure goal of \<160 systolic and \<105 diastolic is achieved. If the therapeutic goal is not achieved after 5 doses, crossover to the alternative study medication will occur.

Group II: Intravenous labetalolActive Control1 Intervention

Intravenous Labetalol: Patients randomized to IV labetalol will receive 20mg initially, followed by escalating doses of 40mg, 80mg, 80mg, then 80mg every 20 minutes until the therapeutic goal is achieved, for a maximum of 5 doses. If the therapeutic goal is not achieved after 5 doses, crossover to the alternative study medication will occur.

0 / 2Eligibility criteria met