Postpartum Evaluation of Nifedipine and Enalapril for Hypertension

Last updated: October 20, 2025
Sponsor: Nebraska Methodist Health System
Overall Status: Active - Recruiting

Phase

4

Condition

High Blood Pressure (Hypertension - Pediatric)

Diabetes And Hypertension

Stress

Treatment

Enalapril 10mg QD

Nifedipine 30mg XL BID

Clinical Study ID

NCT07023003
IRB 1551
  • Ages > 19
  • Female

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. admitted for delivery by cesarean or vaginal delivery

  2. 24 weeks gestation or greater

  3. Pregnancy related hypertension(HTN) or chronic hypertension. Pregnancy relatedhypertension will be defined during the study as either a systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg on two occasions at least 4 hoursapart. This definition is consistent with the ACOG definition for pregnancy relatedHTN in patients without CHTN.

Exclusion

Exclusion Criteria:

  1. Absolute contraindication to either nifedipine or enalapril Relativecontraindications will be reviewed with PI.

  2. Persistent HR <60 or >110

  3. Native language other than English

Study Design

Total Participants: 850
Treatment Group(s): 2
Primary Treatment: Enalapril 10mg QD
Phase: 4
Study Start date:
July 11, 2025
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • Methodist Women's Hospital

    Omaha 5074472, Nebraska 5073708 68022
    United States

    Active - Recruiting

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