Status:

RECRUITING

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

Lead Sponsor:

Nebraska Methodist Health System

Conditions:

Postpartum Preeclampsia

Hypertension in Pregnancy

Eligibility:

FEMALE

19+ years

Phase:

PHASE4

Brief Summary

Randomized trial comparing risk of hospital readmission and hypertensive complications between patients managed on Labetalol compared to Nifedipine.

Detailed Description

Enrollment: Patients will be identified daily using an EMR screening tool. Those that meet inclusion criteria will then be approached by the investigators or research RN for enrollment. Patients cons...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 20 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2024

Estimated Enrollment :

600 Patients enrolled

Trial Details

Trial ID

NCT05309460

Start Date

June 20 2022

End Date

December 1 2024

Last Update

April 12 2024

Active Locations (1)

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Nebraska Methodist Women's Hospital

Omaha, Nebraska, United States, 68022