Hypertension in Pregnancy
Conditions
Keywords
Hypertension, Postpartum, Enalapril, Nifedipine, Readmission
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.
Interventions
DRUGEnalapril 10mg QD
Enalapril 10mg PO QD will be given to manage postpartum hypertension. Duration of treatment to be dictated by primary provider.
DRUGNifedipine 30mg XL BID
Nifedipine 30mg XL BID will be given to manage postpartum hypertension. Duration of treatment to be dictated by primary provider.
Sponsors
Methodist Hospital Foundation
Nebraska Methodist Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open Label Randomized Controlled Equivalence Study
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. admitted for delivery by cesarean or vaginal delivery 2. 24 weeks gestation or greater 3. 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
1. Absolute contraindication to either nifedipine or enalapril Relative contraindications will be reviewed with PI. 2. Persistent HR \<60 or \>110 3. Native language other than English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Readmission | Within 6 weeks of delivery | Number of participants meeting criteria for hospital admission. |
Countries
United States
Contacts
Primary ContactTodd Lovgren, MD
Backup ContactJoshua Dahlke, MD
Outcome results
None listed