Nifedipine and Enalapril vs Nifedipine and Labetalol for Postpartum Hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, unblinded trial compares two second-line antihypertensive strategies for postpartum women already on nifedipine. Eligible participants have hypertensive disorders after delivery and require a second oral agent. After initiating extended-release nifedipine, eligible patients are randomized to receive either enalapril or labetalol as a second medication, with dose adjustments based on blood pressure readings. The trial uses a pragmatic approach, allowing treating clinicians to guide titration and timing of the second agent in real-world postpartum care. The primary aim is to determine which combination more effectively achieves target blood pressure control in the postpartum period.

Why it matters

Who can join: the full rules

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

Where it's running

• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Amol Malshe, M.D. — The Cleveland Clinic
• Study coordinator: Amol Malshe, M.D.
• Email: malshea@ccf.org
• Phone: 216 903-9646

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.