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Recruiting Phase 4 NCT05309460

NCT05309460 Labetalol or Nifedipine for Control of Postpartum Hypertension: A Randomized Controlled Trial

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Clinical Trial Summary
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

Trial Parameters

Condition Postpartum Preeclampsia
Sponsor Nebraska Methodist Health System
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 600
Sex FEMALE
Min Age 19 Years
Max Age N/A
Start Date 2022-06-20
Completion 2024-05-01
Interventions
Labetalol Oral TabletNIFEdipine ER

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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

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