Postpartum Evaluation of Antihypertensives for Control of Hypertension: A Randomized Controlled Equivalence Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 850
- Locations
- 1
- Primary Endpoint
- Hospital Readmission
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •admitted for delivery by cesarean or vaginal delivery
- •24 weeks gestation or greater
- •Pregnancy related hypertension(HTN) or chronic hypertension. Pregnancy related 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.
Exclusion Criteria
- •Absolute contraindication to either nifedipine or enalapril Relative contraindications will be reviewed with PI.
- •Persistent HR <60 or >110
- •Native language other than English
Arms & Interventions
Nifedipine XR
Patients will be randomized to receive nifedipine 30mg XR BID. Any additional changes in treatment will be at the discretion of their provider.
Intervention: Nifedipine 30mg XL BID (Drug)
Enalapril 10mg QD
Patients will be administered 10mg enalapril daily. Any additional intervention or changes in management of their hypertension will be at the discretion of their primary provider.
Intervention: Enalapril 10mg QD (Drug)
Outcomes
Primary Outcomes
Hospital Readmission
Time Frame: Within 6 weeks of delivery
Number of participants meeting criteria for hospital admission.
Secondary Outcomes
No secondary outcomes reported
Investigators
Todd Lovgren
Principal Investigator
Nebraska Methodist Health System