Nifedipine and Enalapril vs Nifedipine and Labetalol for the Treatment of Postpartum Hypertension Study

NCT07363343 | Not Yet Recruiting

• 1 other identifier: 24-918
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine if nifedipine and enalapril will have better blood pressure control in the postpartum setting compared to nifedipine and labetalol.

Conditions

Hypertension; Postpartum Preeclampsia

Outcome Measures

Primary Outcomes (1)

• Composite postpartum hypertension treatment failure within 6 weeks postpartum

  The primary outcome is a binary composite outcome, defined as the occurrence of any one or more of the following events within 6 weeks postpartum: Prolonged hospitalization, Hospital readmission for hypertension, Persistence of hypertension beyond 14 days postpartum, Requirement for acute treatment of severe-range hypertension. Participants experiencing at least one component will be classified as having met the composite outcome.

  6-weeks postpartum

Study Arms (2)

Nifedipine and Enalapril

EXPERIMENTAL

Nifedipine 60mg by mouth every twelve hours plus Enalapril 5mg by mouth every twelve hours

Drug: Nifedipine and Enalapril

Nifedipine and Labetalol

ACTIVE COMPARATOR

Nifedipine 60mg by mouth every twelve hours plus Labetalol 200mg by mouth every twelve hours

Drug: Nifedipine and Labetalol

Interventions

Nifedipine and Enalapril DRUG

Nifedipine 60mg by mouth every twelve hours plus Enalapril 5mg by mouth every twelve hours

Also known as: Procardia and Vasotec

Nifedipine and Enalapril

Nifedipine and Labetalol DRUG

Nifedipine 60mg by mouth every twelve hours plus Labetalol 200mg by mouth every twelve hours

Also known as: Procardia and Trandete

Nifedipine and Labetalol

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Postnatal women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postpartum women aged 18 years or older
• Clinical diagnosis of hypertensive disorder in pregnancy (gestational hypertension, chronic hypertension, preeclampsia with or without severe features)
• Taking Nifedipine 60 mg every 12 hours for blood pressure control
• Persistently elevated blood pressure at/above 140/90 mmHg in a 24-hour time period or have one or more severe range blood pressure at/above 160/110 mmHg requiring a second antihypertensive medication
• English speaking

You may not qualify if:

• Taking ≥2 antihypertensive agents during pregnancy
• Heart block
• Heart rate \<60 or \>120 beats per minute
• Heart failure
• Creatinine \>1.5 mg/dL
• Renal artery stenosis
• Active connective tissue disease
• Cerebrovascular accident
• Failed treatment or contraindications to nifedipine, enalapril or labetalol

Sponsors & Collaborators

• The Cleveland Clinic: lead

MeSH Terms

Conditions

Hypertension

Interventions

Nifedipine; Enalapril; Enalaprilat; Labetalol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Salicylamides; Amides; Amines

Study Officials

• Amol Malshe, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amol Malshe, M.D.

CONTACT

216 903-9646; malshea@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: January 23, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share