Clinical trial NCT07023003: Postpartum Evaluation of Antihypertensives for Control of Hypertension: A Randomized Controlled Equivalence Study
Official title: Postpartum Evaluation of Antihypertensives for Control of Hypertension: A Randomized Controlled Equivalence Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Hypertension in Pregnancy
Keywords: Hypertension
Postpartum
Enalapril
Nifedipine
Readmission
Lead sponsor: Nebraska Methodist Health System
Sponsor class: OTHER
Collaborators: name: Methodist Hospital Foundation
First posted: 2025-06-15
Enrollment: 850
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open Label Randomized Controlled Equivalence Study
Primary purpose: TREATMENT

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 we don't think 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.

We will identify and offer enrollment to women who are admitted for delivery with documented hypertension- patients 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 will be the primary goal of the study.

The only intervention of the trial will be to assign which medication the patient 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 patient's primary provider.


Eligibility criteria: Patient Inclusion:

Any patient admitted for delivery by cesarean or vaginal delivery at 24 weeks gestation or greater with hypertension(HTN). 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. Patients with CHTN who also meet this criteria will be included. Following enrollment, treatment will be escalated at discretion of primary provider with the goal of normotension.

Patient Exclusion:

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

Primary outcomes:
measure: Hospital Readmission
timeFrame: Within 6 weeks of delivery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Nebraska Methodist Health System
name: Todd Lovgren, MD
role: PRINCIPAL_INVESTIGATOR
References: