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Nifedipine vs Labetalol for Postpartum Hypertension (SCARPH Trial)

Phase 3

Recruiting

Research Sponsored by Loma Linda University

Eligibility Criteria Checklist

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

Must have

Women who develop postpartum hypertension* after delivery of the placenta or chronic hypertensive postpartum women who require medication for blood pressure control

Female

Must not have

Native language other than English or Spanish

History of moderate persistent asthma, coronary artery disease, heart failure, AV heart block, pulmonary edema

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-6 weeks following delivery

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial will compare two medications to see which works better for controlling high blood pressure after pregnancy.

Who is the study for?

This trial is for women who have high blood pressure after childbirth (postpartum hypertension). They must need medication to control their blood pressure, which is defined as having a systolic BP of at least 140mmHg or diastolic BP of at least 90mmHg. Women with certain heart conditions, asthma, or contraindications to the study drugs cannot participate.

What is being tested?

The trial aims to find out if oral Nifedipine or oral Labetalol is better for managing high blood pressure in women after they've given birth. It's a randomized control trial, meaning participants are randomly assigned one of these medications to compare effectiveness.

What are the potential side effects?

Nifedipine may cause swelling, flushing, and headaches while Labetalol could lead to fatigue, dizziness, and possible scalp tingling. Both can affect heart rate and might not be suitable for those with certain pre-existing conditions.

Eligibility Criteria

Inclusion Criteria

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

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I developed high blood pressure after giving birth or need medication for it.

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I am female.

Exclusion Criteria

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

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My first language is not English or Spanish.

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I have a history of asthma, heart disease, or fluid in my lungs.

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I cannot take Nifedipine or Labetalol due to adverse reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-6 weeks following delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-6 weeks following delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-6 weeks following delivery for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Composite maternal morbidity

Secondary study objectives

Length of hospital stay of mothers

Total number of participants who have need for second antihypertensive agent

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Oral NifedipineActive Control1 Intervention

Participants will receive oral nifedipine for blood pressure control. Dosage may initially start at one 10mg capsule by mouth three times per 24 hours (total of 30mg a day), however dosage may be increased by 30mg increments (i.e. 20mg capsule three times a day for a total of 60mg a day). Maximum dosage for oral Nifedipine will be 120mg per day.

Group II: Oral LabetalolActive Control1 Intervention

Participants will receive oral labetalol for blood pressure control. Dosage may initially start at one 200mg tablet by mouth two times per 12 hours (total of 400mg every a day), however dosage may be increased by 100-200mg increments at a time. Maximum dosage for oral labetalol will be 2400mg per day.

0 / 5Eligibility criteria met