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Nifedipine for Pre-eclampsia

Phase 4

Recruiting

Led By Todd Lovgren, MD

Research Sponsored by Nebraska Methodist Health System

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial compared the risk of patients being readmitted to the hospital and experiencing complications related to high blood pressure between those treated with Labetalol and those treated with Nifedipine.

Who is the study for?

This trial is for patients who have given birth at or beyond 24 weeks of pregnancy and are experiencing high blood pressure, defined as a systolic pressure ≥140mmHg or diastolic pressure ≥90mmHg. They must have had these readings twice, at least 4 hours apart.Check my eligibility

What is being tested?

The study compares Labetalol and Nifedipine ER to see which is better for managing postpartum hypertension. It looks at the risk of being readmitted to the hospital and developing complications related to high blood pressure after treatment.See study design

What are the potential side effects?

Possible side effects from Labetalol may include fatigue, dizziness, or nausea. Nifedipine can cause swelling in the legs, flushing, headaches, and could potentially lower heart rate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Readmission

Secondary outcome measures

Medication change or discontinuation

Medication failure

Trial Design

2Treatment groups

Active Control

Group I: NifedipineActive Control1 Intervention

Patients randomized to Nifedipine will be started on Nifedipine XR 30mg BID. Escalation in therapy to be determined by primary provider. Maximum dose of Nifedipine is 120mg daily. All patients will be monitored for signs and symptoms of hypotension or medication side effect- severe HA, orthostasis, syncope.

Group II: LabetalolActive Control1 Intervention

Patients randomized to Labetalol will be started on 200mg TID. Escalation in therapy to be determined by primary provider. Maximum dose is 2400mg in a day. All patients will be monitored for signs and symptoms of hypotension or medication side effect- orthostasis, syncope, bradycardia.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Nebraska Methodist Health SystemLead Sponsor

2 Previous Clinical Trials

155 Total Patients Enrolled

Todd Lovgren, MDPrincipal InvestigatorNebraska Methodist Health System

Frequently Asked Questions

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

Are there any ongoing efforts to enroll participants in this research study at the moment?

"As per the information on clinicaltrials.gov, recruitment for this study is ongoing. The trial was first listed on 20th June 2022 and last modified on 10th April 2024."

Answered by AI

Has Nifedipine received approval from the FDA?

"Given the Phase 4 status of this trial, indicating regulatory approval, our team ranks nifedipine's safety at the highest level of 3."

Answered by AI

What is the current number of individuals undergoing treatment in this medical study?

"Indeed, information available on clinicaltrials.gov confirms that recruitment is ongoing for this research endeavor. The trial was first listed on June 20th, 2022 and last revised on April 10th, 2024. Enrollment targets are set at a total of 600 participants from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Labetalol or Nifedipine for Control of Postpartum Hypertension: A Randomized Controlled Trial

2022. "Labetalol or Nifedipine for Control of Postpartum Hypertension: A Randomized Controlled Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05309460.