Postpartum Evaluation of Nifedipine and Enalapril for Hypertension

NCT ID: NCT07023003

Last Updated: 2025-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

850 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-11

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension in Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open Label Randomized Controlled Equivalence Study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Nifedipine 30mg XL BID

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Enalapril 10mg QD

Intervention Type DRUG

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

Interventions

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Enalapril 10mg QD

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

Intervention Type DRUG

Nifedipine 30mg XL BID

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

Intervention Type DRUG

Other Intervention Names

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vasotec enalaprilat epaned adalat procardia

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Methodist Hospital Foundation

UNKNOWN

Sponsor Role collaborator

Nebraska Methodist Health System

OTHER

Sponsor Role lead

Responsible Party

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Todd Lovgren

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Todd Lovgren, MD

Role: PRINCIPAL_INVESTIGATOR

Nebraska Methodist Health System

Locations

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Methodist Women's Hospital

Omaha, Nebraska, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Todd Lovgren, MD

Role: CONTACT

14028151970

Joshua Dahlke, MD

Role: CONTACT

14028151970

Facility Contacts

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Todd Lovgren

Role: primary

4028151970

Joshua Dahlke, MD

Role: backup

4028151970

Other Identifiers

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IRB 1551

Identifier Type: -

Identifier Source: org_study_id

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