Nifedipine versus enalapril for postpartum high blood pressure
Postpartum Evaluation of Antihypertensives for Control of Hypertension: A Randomized Controlled Equivalence Study
This will see if nifedipine or enalapril better controls high blood pressure in women after giving birth.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 850 (estimated) |
| Ages | 19 Years and up |
| Sex | Female |
| Sponsor | Nebraska Methodist Health System Academic / other |
| Locations | 1 site (Omaha, Nebraska) |
| Trial ID | NCT07023003 on ClinicalTrials.gov |
What this trial studies
This open-label, randomized phase 4 trial assigns postpartum women with chronic or pregnancy-related hypertension to receive either nifedipine 30 mg XL twice daily or enalapril 10 mg once daily. The study is designed as an equivalence comparison with the primary outcome being hospital readmission for hypertensive complications during the postpartum period. Participants are identified at delivery (≥24 weeks gestation) and must be English-speaking and without contraindications to either medication. The trial is conducted at Methodist Women's Hospital in Omaha, Nebraska.
Who should consider this trial
Good fit: Women admitted for delivery at 24 weeks gestation or later with chronic or pregnancy-related hypertension who speak English and have no contraindications to nifedipine or enalapril are ideal candidates.
Not a fit: People with absolute contraindications to either drug, persistent heart rate under 60 or over 110, or who do not speak English would not be eligible and would not benefit from participation.
Why it matters
Potential benefit: If successful, the results could clarify which widely available medication is equally safe and effective for preventing postpartum hypertensive complications and readmissions.
How similar studies have performed: Previous trials have shown nifedipine outperformed labetalol for postpartum hypertension, but enalapril has not been directly compared to nifedipine, so this head-to-head comparison is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. admitted for delivery by cesarean or vaginal delivery 2. 24 weeks gestation or greater 3. Pregnancy related hypertension(HTN) or chronic hypertension. Pregnancy related hypertension will be defined during the study as either a systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg on two occasions at least 4 hours apart. This definition is consistent with the ACOG definition for pregnancy related HTN in patients without CHTN. Exclusion Criteria: 1. Absolute contraindication to either nifedipine or enalapril Relative contraindications will be reviewed with PI. 2. Persistent HR \<60 or \>110 3. Native language other than English
Where this trial is running
Omaha, Nebraska
- Methodist Women's Hospital — Omaha, Nebraska, United States (Recruiting)
Study contacts
- Principal investigator: Todd Lovgren, MD — Nebraska Methodist Health System
- Study coordinator: Todd Lovgren, MD
- Email: todd.lovgren@nmhs.org
- Phone: 14028151970
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.