Comparing Labetalol and Nifedipine for Managing Postpartum Hypertension
Labetalol or Nifedipine for Control of Postpartum Hypertension: A Randomized Controlled Trial
This study is testing whether Labetalol or Nifedipine is better at managing high blood pressure after childbirth to help new moms avoid going back to the hospital.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 19 Years and up |
| Sex | Female |
| Sponsor | Nebraska Methodist Health System Academic / other |
| Locations | 1 site (Omaha, Nebraska) |
| Trial ID | NCT05309460 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of Labetalol and Nifedipine in managing postpartum hypertension and reducing the risk of hospital readmission and hypertensive complications. Patients who meet the inclusion criteria will be randomly assigned to receive either Labetalol or Nifedipine, with treatment escalation determined by their primary provider. The study will enroll a total of 600 patients, with 300 in each treatment arm, and monitor them for signs of hypotension and medication side effects. The goal is to achieve normotension for at least 12 hours before discharge.
Who should consider this trial
Good fit: Ideal candidates are patients admitted for delivery at 24 weeks gestation or greater who have hypertension defined as a systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg.
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 provide a more effective treatment option for managing postpartum hypertension, potentially reducing hospital readmissions.
How similar studies have performed: Other studies have explored the management of postpartum hypertension, but this specific comparison of Labetalol and Nifedipine is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Any patient admitted for delivery by cesarean or vaginal delivery at 24 weeks gestation or greater with hypertension(HTN). 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. Following enrollment, treatment will be escalated at discretion of primary provider with the goal of normotension. 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
Omaha, Nebraska
- 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: 4028151970
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.