Postpartum Evaluation of Nifedipine and Enalapril for Hypertension

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
Nebraska Methodist Health System
Study ID
NCT07023003
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Hypertension in Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Enalapril 10mg QD — DRUG
    Enalapril 10mg PO QD will be given to manage postpartum hypertension. Duration of treatment to be dictated by primary provider.
  • Nifedipine 30mg XL BID — DRUG
    Nifedipine 30mg XL BID will be given to manage postpartum hypertension. Duration of treatment to be dictated by primary provider.

Study Details

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.

Key Dates

Start date
Jul 11, 2025
Status verified
Oct 2025
Primary completion
Jul 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
850 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Methodist Women's HospitalOmahaNebraska68022
Todd Lovgren
[email protected]
4028151970
Joshua Dahlke, MD
[email protected]
4028151970
Todd Lovgren, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Methodist Women's Hospital· Omaha, NE

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