Postpartum Evaluation of Nifedipine and Enalapril for Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Enalapril 10mg QD, Nifedipine 30mg XL BID.
- Who it may be relevant to
- Registry conditions: Hypertension in Pregnancy. Basic parameters: from 19 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Postpartum Evaluation of Antihypertensives for Control of Hypertension: A Randomized Controlled Equivalence Study
Overview
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
- Drug Enalapril 10mg QD
Enalapril 10mg PO QD will be given to manage postpartum hypertension. Duration of treatment to be dictated by primary provider. - Drug Nifedipine 30mg XL BID
Nifedipine 30mg XL BID will be given to manage postpartum hypertension. Duration of treatment to be dictated by primary provider.
Primary outcome measures
- Hospital Readmission [Time frame: Within 6 weeks of delivery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Methodist Women's Hospital — Omaha
Identifiers
NCT: NCT07023003 · IRB 1551