Recruiting

Nifedipine & Enalapril

Sponsor:

The Cleveland Clinic

Code:

NCT07363343

Conditions

Hypertension

Postpartum Preeclampsia

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nifedipine and Enalapril

Nifedipine and Labetalol

Study Details

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

Study ID

NCT07363343

Start date

Mar 10, 2026

Status verified date

Jul, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nifedipine and Enalapril

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

active comparator: Nifedipine and Labetalol

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

Interventions

Nifedipine and Enalapril

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

Nifedipine and Labetalol

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

Primary outcome measure

  • Composite postpartum hypertension treatment failure within 6 weeks postpartum [ Time Frame: 6-weeks postpartum ]

Central Contacts and Locations

Central contacts

Amol Malshe, M.D.

216 903-9646malshea@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Amol Malshe

216-903-9646malshea@ccf.org

More Information

Sponsor

The Cleveland Clinic

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-08-03.