NCT07023003

Postpartum Evaluation of Nifedipine and Enalapril for Hypertension

Postpartum Evaluation of Antihypertensives for Control of Hypertension: A Randomized Controlled Equivalence Study

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 850 (estimated)
• Sponsor: Nebraska Methodist Health System · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2025-07-11
• Primary completion: 2028-07-01
• Completion: 2028-12-01
• First posted: 2025-06-15
• Last updated: 2025-10-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study