About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Absolute contraindication to either nifedipine or enalapril Relative contraindications will be reviewed with PI.
Persistent HR <60 or >110
Native language other than English
Trial design
Parallel
Treatments tested in this trial
Enalapril 10mg QD
DrugEnalapril 10mg PO QD will be given to manage postpartum hypertension. Duration of treatment to be dictated by primary provider.
Nifedipine 30mg XL BID
DrugNifedipine 30mg XL BID will be given to manage postpartum hypertension. Duration of treatment to be dictated by primary provider.
Treatment groups
Trial outcomes
Primary outcomes
Hospital Readmission
Number of participants meeting criteria for hospital admission.
Sponsors and contacts
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Nebraska Methodist Health System
Lead sponsor
Methodist Hospital Foundation
Collaborator