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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-6 weeks following delivery
Awards & highlights
SCARPH Trial 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.Check my eligibility
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.See study design
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.
SCARPH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I developed high blood pressure after giving birth or need medication for it.
Select...
I am female.
SCARPH Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite maternal morbidity
Secondary outcome measures
Length of hospital stay of mothers
Total number of participants who have need for second antihypertensive agent
SCARPH 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.
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Who is running the clinical trial?
Loma Linda UniversityLead Sponsor
306 Previous Clinical Trials
260,488 Total Patients Enrolled
1 Trials studying Hypertension
70 Patients Enrolled for Hypertension
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If you recently had a baby and your blood pressure is too high, you will not be able to join the study.I developed high blood pressure after giving birth or need medication for it.My first language is not English or Spanish.Your heart rate is lower than 60 or higher than 110.I am female.I have a history of asthma, heart disease, or fluid in my lungs.I cannot take Nifedipine or Labetalol due to adverse reactions.
Research Study Groups:
This trial has the following groups:- Group 1: Oral Nifedipine
- Group 2: Oral Labetalol
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants were recruited for this research endeavor?
"Yes, data on clinicaltrials.gov affirms that this study is presently recruiting participants. This trial was initially posted on June 1st 2023 and has been revised as recent March 22nd 2023. The research project seeks to enrol 500 people from a single site."
Answered by AI
Is this research currently seeking participants?
"Affirmative. Clinicaltrials.gov displays that this clinical research is still recruiting subjects; the trial was initially advertised on June 1st 2023 and modified lastly on March 22nd 2023. The study aims to enrol 500 individuals from one medical facility."
Answered by AI
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