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Calcium Channel Blocker

REPAIR ARM for Pre-eclampsia (REPAIR Trial)

Q: What are the potential risks and hazards associated with the implementation of REPAIR ARM in patients?

<p>Based on our assessment at Power, the safety rating for REPAIR ARM is 3. This score reflects that it's a Phase 3 trial with evidence supporting both effectiveness and multiple rounds of safety data.</p>

Q: Are there ongoing efforts to recruit participants for this clinical trial?

<p>According to the latest information on clinicaltrials.gov, this particular trial is not currently accepting new participants. The trial's initial posting date was July 1st, 2024 and it was last updated on January 23rd, 2024. However, there are presently a considerable number of other trials (798 in total) actively seeking patients at this time.</p>

Phase 3

Waitlist Available

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

Age 18 - 50

Hypertensive disorders of pregnancy (HDP) diagnosis (gestational hypertension or preeclampsia) according to ACOG guidelines

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year postpartum

Awards & highlights

REPAIR Trial Summary

This trial aims to study the impact of closely monitoring and controlling blood pressure after giving birth on the overall heart health of mothers. The goal is to reduce the risk of developing long-term high blood pressure and

Who is the study for?

This trial is for women aged 18-50 who have had high blood pressure or preeclampsia during pregnancy, can communicate in English or Spanish, and are within the first three days after giving birth. It's not for those with pre-pregnancy hypertension or diabetes, planning to transfer hospitals postpartum, allergic to nifedipine, or unable to consent.Check my eligibility

What is being tested?

The study tests whether intensive blood pressure control using NIFEdipine ER after childbirth can improve heart health, lower the risk of long-term high blood pressure, and reverse vascular damage caused by hypertensive disorders during pregnancy.See study design

What are the potential side effects?

NIFEdipine ER may cause side effects such as headache, swelling of the ankles/feet (fluid retention), dizziness/lightheadedness due to low blood pressure, flushing (warmth/redness/itchy skin), fatigue and nausea.

REPAIR Trial Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 50 years old.

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I was diagnosed with high blood pressure during pregnancy.

REPAIR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year 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

Chronic hypertension

Secondary outcome measures

Arterial stiffness

Composite severe maternal morbidity

Flow-mediated dilation

+2 more

REPAIR Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: REPAIR ARMExperimental Treatment1 Intervention

Intensive postpartum BP control with Nifedipine ER initiation at SBP≥140 mmHg or DBP≥90 mmHg and maintaining BP at <140/90 mmHg during the first 6 weeks postpartum

Group II: CONTROL ARMActive Control1 Intervention

A group of usual care with Nifedipine ER initiation at SBP≥150 mmHg or DBP≥100 mmHg and maintaining BP at <150/100 mmHg during the first 6 weeks postpartum.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NIFEdipine ER

2021

Completed Phase 4

~230

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor

610 Previous Clinical Trials

1,162,095 Total Patients Enrolled

Frequently Asked Questions

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

What are the potential risks and hazards associated with the implementation of REPAIR ARM in patients?

"Based on our assessment at Power, the safety rating for REPAIR ARM is 3. This score reflects that it's a Phase 3 trial with evidence supporting both effectiveness and multiple rounds of safety data."

Answered by AI

Are there ongoing efforts to recruit participants for this clinical trial?

"According to the latest information on clinicaltrials.gov, this particular trial is not currently accepting new participants. The trial's initial posting date was July 1st, 2024 and it was last updated on January 23rd, 2024. However, there are presently a considerable number of other trials (798 in total) actively seeking patients at this time."

Answered by AI

Recent research and studies

BMJ Quality & SafetyJournal

Comparing Standard Office-based Follow-up with Text-based Remote Monitoring in the Management of Postpartum Hypertension: A Randomised Clinical Trial

Hirshberg, Adi, Katheryne Downes, and Sindhu Srinivas. 2018. “Comparing Standard Office-based Follow-up with Text-based Remote Monitoring in the Management of Postpartum Hypertension: A Randomised Clinical Trial”. BMJ Quality & Safety. BMJ. doi:10.1136/bmjqs-2018-007837.

clinicaltrials.govStudy

Reducing the Risk of Chronic Hypertension and Improving Vascular Function Following Preeclampsia

Anna Palatnik, MD 2024. "Reducing the Risk of Chronic Hypertension and Improving Vascular Function Following Preeclampsia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06220721.

All > Preeclampsia