RecruitingPhase 4NCT07023003

Postpartum Evaluation of Nifedipine and Enalapril for Hypertension

Postpartum Evaluation of Antihypertensives for Control of Hypertension: A Randomized Controlled Equivalence Study


Sponsor

Nebraska Methodist Health System

Enrollment

850 participants

Start Date

Jul 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open label, randomized controlled trial designed to compare nifedipine and enalapril in the management of postpartum hypertension. This is an equivalence study- meaning it is not expected one medication is better than the other. Nifedipine has been shown to be better than another common blood pressure medicine, labetalol, for postpartum hypertension but enalapril which is also used worldwide to manage blood pressure postpartum, has not yet been evaluated or compared to nifedipine. Investigators will identify and offer enrollment to women who are admitted for delivery with documented hypertension- participants with either chronic hypertension or pregnancy related hypertension will be included. Our hypothesis is both medications are safe and effective in managing blood pressure and preventing readmission for hypertensive complications during the postpartum period so evaluating the rate of readmission is the primary goal of the study. The only intervention of the trial will be to assign which medication the participant starts taking. Any decisions after that point- stopping medication, changing doses, additional medications, discharge from the hospital, etc, will all be at the discretion of the participant's primary provider.


Eligibility

Sex: FEMALEMin Age: 19 Years

Inclusion Criteria3

  • admitted for delivery by cesarean or vaginal delivery
  • weeks gestation or greater
  • 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 Criteria3

  • Absolute contraindication to either nifedipine or enalapril Relative contraindications will be reviewed with PI.
  • Persistent HR \<60 or \>110
  • Native language other than English

Interventions

DRUGEnalapril 10mg QD

Enalapril 10mg PO QD will be given to manage postpartum hypertension. Duration of treatment to be dictated by primary provider.

DRUGNifedipine 30mg XL BID

Nifedipine 30mg XL BID will be given to manage postpartum hypertension. Duration of treatment to be dictated by primary provider.


Locations(1)

Methodist Women's Hospital

Omaha, Nebraska, United States

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NCT07023003


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