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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 hours
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have been diagnosed with chronic high blood pressure or had high blood pressure during pregnancy.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average Time to Initial Blood Pressure Control (minutes)
Secondary outcome measures
Average Number of Recurrence of Severe Blood Pressure
Total Number of Participants Who Need for Second Antihypertensive Agent

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.

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,424 Previous Clinical Trials
2,472,923 Total Patients Enrolled
27 Trials studying Hypertension
57,792 Patients Enrolled for Hypertension
Whitney A. Booker, MDPrincipal InvestigatorColumbia University

Media Library

Labetalol (Beta Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT05139238 — Phase 4
Hypertension Research Study Groups: Oral Nifedipine, Intravenous labetalol
Hypertension Clinical Trial 2023: Labetalol Highlights & Side Effects. Trial Name: NCT05139238 — Phase 4
Labetalol (Beta Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05139238 — Phase 4

Frequently Asked Questions

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

Can you provide details on any previous research done with Intravenous labetalol?

"Currently, 17 trials are studying Intravenous labetalol and 3 of these clinical studies have progressed to Phase 3. Despite the primary location for research being Breckenridge, Colorado, there is an additional 92 sites hosting investigations on this drug."

Answered by AI

Has this experimental research been conducted before?

"Intravenous labetalol has been studied exhaustively since its first trial in 2007, which was sponsored by Encysive Pharmaceuticals. The completion of the initial investigation involving 27 participants prompted Phase 2 drug approval. Currently, 17 active clinical trials are taking place across 66 cities and 6 countries worldwide."

Answered by AI

How many individuals are partaking in this research endeavor?

"This research initiative is not currently recruiting participants. Originally posted on the first of January 2022, it was last updated in November 2021. If you're looking for other trails to consider, there are 1000 studies related to hypertension and 17 involving intravenous labetalol that are actively accepting candidates."

Answered by AI

For what medical complaints is Intravenous labetalol utilized?

"Intravenous labetalol is a commonly prescribed medication to treat vasospastic angina. It is also useful in treating pheochromocytomas, the effects of high altitude, and premature labour."

Answered by AI

To what extent is Intravenous labetalol a health risk to individuals?

"The safety of intravenous labetalol is believed to be high, as the treatment has achieved Phase 4 status and thus been granted approval."

Answered by AI

Are there vacancies available for those who wish to join this research?

"Per the clinicaltrials.gov website, this trial is not currently enrolling patients. It was posted on January 1st 2022 and last updated November 18th 2021; however, there are numerous other studies actively recruiting people at this time - 1017 to be exact."

Answered by AI
~55 spots leftby Jan 2025