Recruiting

Nifedipine & Enalapril

Sponsor:

Nebraska Methodist Health System

Code:

NCT07023003

Conditions

Hypertension in Pregnancy

Eligibility Criteria

Sex: Female

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Enalapril 10mg QD

Nifedipine 30mg XL BID

Study Details

Brief 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.

Conditions

Hypertension in Pregnancy

Study ID

NCT07023003

Start date

Jul 11, 2025

Status verified date

Oct, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 19+

Healthy Volunteers: Not accepted

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 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 Criteria:

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

Study Design

Enrollment

850 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Nifedipine XR

Patients will be randomized to receive nifedipine 30mg XR BID. Any additional changes in treatment will be at the discretion of their provider.

experimental: Enalapril 10mg QD

Patients will be administered 10mg enalapril daily. Any additional intervention or changes in management of their hypertension will be at the discretion of their primary provider.

Interventions

Enalapril 10mg QD

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

Nifedipine 30mg XL BID

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

Primary outcome measure

  • Hospital Readmission [ Time Frame: Within 6 weeks of delivery ]

Central Contacts and Locations

Central contacts

Locations

Methodist Women's Hospital

Recruiting

Omaha, Nebraska, United States, 68022

Contacts

Principal Investigator:

Todd Lovgren, MD

More Information

Sponsor

Nebraska Methodist Health System

Last update posted

Oct 22, 2025

Last verified

Oct, 2025

Keywords

  • Hypertension
  • Postpartum
  • Enalapril
  • Nifedipine
  • Readmission

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nebraska Methodist Health System on 2025-10-22.