Comparing Nifedipine and Labetalol for postpartum high blood pressure
Safest Choice of Antihypertensive Regimen for Postpartum Hypertension: A Randomized Control Trial (SCARPH)
This study is testing whether the medication Nifedipine or Labetalol works better to lower high blood pressure in women after giving birth.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Loma Linda University Academic / other |
| Locations | 1 site (Loma Linda, California) |
| Trial ID | NCT05551104 on ClinicalTrials.gov |
What this trial studies
This randomized control trial aims to determine whether oral Nifedipine or oral Labetalol is more effective in managing high blood pressure in women after childbirth. High blood pressure is a common complication during and after pregnancy, and effective management is crucial to prevent serious health issues. Participants will receive either Nifedipine or Labetalol, with no experimental drugs involved. The study will assess the efficacy of these medications in controlling postpartum hypertension.
Who should consider this trial
Good fit: Ideal candidates are women who develop postpartum hypertension requiring treatment after delivery.
Not a fit: Patients with contraindications to either Nifedipine or Labetalol or those with certain cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for postpartum hypertension, enhancing maternal health outcomes.
How similar studies have performed: While both medications are considered safe, few studies have directly compared their effectiveness, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female * Women who develop postpartum hypertension\* after delivery of the placenta or chronic hypertensive postpartum women who require medication for blood pressure control. * Postpartum hypertension requiring treatment are defined as systolic blood pressure greater than or equal to 140mmHg or diastolic blood pressure greater than or equal to 90mmHg on at least 2 occasions at least 4 hours apart, or systolic blood pressure greater than or equal to 160mmHg or diastolic blood pressure greater than 110mmHg sustained for more than 15 minutes. Exclusion Criteria: * History of moderate persistent asthma, coronary artery disease, heart failure, AV heart block, pulmonary edema * Contraindication to either Nifedipine or Labetalol * HR \<60 or \>110 * Native language other than English or Spanish
Where this trial is running
Loma Linda, California
- Loma Linda University Health — Loma Linda, California, United States (Recruiting)
Study contacts
- Study coordinator: Ashra Denise B Tugung, BSc
- Email: atugung@llu.edu
- Phone: 9096515580
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.