Postpartum Evaluation of Nifedipine and Enalapril for Hypertension

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age19+
SponsorNebraska Methodist Health System

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Enalapril 10mg QD

    Drug

    Enalapril 10mg PO QD will be given to manage postpartum hypertension. Duration of treatment to be dictated by primary provider.

  • Nifedipine 30mg XL BID

    Drug

    Nifedipine 30mg XL BID will be given to manage postpartum hypertension. Duration of treatment to be dictated by primary provider.

Treatment groups

850 Participants
are divided into 2 treatment groups
Group A: Nifedipine XRActive comparator 1 intervention
Group B: Enalapril 10mg QDExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Hospital Readmission

Number of participants meeting criteria for hospital admission.

Time frame
Within 6 weeks of delivery

Secondary outcomes

Other outcomes

Sponsors and contacts

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Nebraska Methodist Health System

Lead sponsor

Methodist Hospital Foundation

Collaborator