NCT05309460 Labetalol or Nifedipine for Control of Postpartum Hypertension: A Randomized Controlled Trial
| NCT ID | NCT05309460 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Nebraska Methodist Health System |
| Condition | Postpartum Preeclampsia |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2022-06-20 |
| Primary Completion | 2024-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 600 participants in total. It began in 2022-06-20 with a primary completion date of 2024-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Randomized trial comparing risk of hospital readmission and hypertensive complications between patients managed on Labetalol compared to Nifedipine.
Eligibility 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
Contact & Investigator
Todd Lovgren, MD
PRINCIPAL INVESTIGATOR
Nebraska Methodist Health System
Frequently Asked Questions
Who can join the NCT05309460 clinical trial?
This trial is open to female participants only, aged 19 Years or older, studying Postpartum Preeclampsia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05309460 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05309460 currently recruiting?
Yes, NCT05309460 is actively recruiting participants. Contact the research team at todd.lovgren@nmhs.org for enrollment information.
Where is the NCT05309460 trial being conducted?
This trial is being conducted at Omaha, United States.
Who is sponsoring the NCT05309460 clinical trial?
NCT05309460 is sponsored by Nebraska Methodist Health System. The principal investigator is Todd Lovgren, MD at Nebraska Methodist Health System. The trial plans to enroll 600 participants.