Postpartum Evaluation of Nifedipine and Enalapril for Hypertension

NCT07023003 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: IRB 1551
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 1

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

Keywords

Hypertension; Postpartum; Enalapril; Nifedipine; Readmission

Outcome Measures

Primary Outcomes (1)

• Hospital Readmission

  Number of participants meeting criteria for hospital admission.

  Within 6 weeks of delivery

Study Arms (2)

Nifedipine XR

ACTIVE COMPARATOR

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

Drug: Nifedipine 30mg XL BID

Enalapril 10mg QD

EXPERIMENTAL

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.

Drug: Enalapril 10mg QD

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.

Also known as: vasotec, enalaprilat, epaned

Enalapril 10mg QD

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.

Also known as: adalat, procardia

Nifedipine XR

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Nebraska Methodist Health System: lead
• Methodist Hospital Foundation: collaborator

Study Sites (1)

Methodist Women's Hospital

Omaha, Nebraska, 68022, United States

RECRUITING

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Hypertension

Interventions

Enalapril; Enalaprilat; Nifedipine

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Todd Lovgren, MD

  Nebraska Methodist Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Todd Lovgren, MD

CONTACT

14028151970; todd.lovgren@nmhs.org

Joshua Dahlke, MD

CONTACT

14028151970; joshua.dahlke@nmhs.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Open Label Randomized Controlled Equivalence Study

Study Record Dates

• First Submitted: June 8, 2025
• First Posted: June 15, 2025
• Study Start: July 11, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 1 year after completion of the study and for up to 10 years after completion assuming continued access to data is available.
• Access Criteria: Access will be provided on a case by case basis. If shared, an encrypted and deidentified spreadsheet with non-identifying data will be provided.

Locations

US (1)