Nifedipine and Enalapril vs Nifedipine and Labetalol for the Treatment of Postpartum Hypertension Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThe Cleveland Clinic
About this trial
To determine if nifedipine and enalapril will have better blood pressure control in the postpartum setting compared to nifedipine and labetalol.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Postpartum women aged 18 years or older
Clinical diagnosis of hypertensive disorder in pregnancy (gestational hypertension, chronic hypertension, preeclampsia with or without severe features)
Taking Nifedipine 60 mg every 12 hours for blood pressure control
Persistently elevated blood pressure at/above 140/90 mmHg in a 24-hour time period or have one or more severe range blood pressure at/above 160/110 mmHg requiring a second antihypertensive medication
Disqualifiers
Taking ≥2 antihypertensive agents during pregnancy
Heart block
Heart rate <60 or >120 beats per minute
Heart failure
Trial design
Design model
Parallel
Treatments tested in this trial
Nifedipine and Enalapril
DrugNifedipine 60mg by mouth every twelve hours plus Enalapril 5mg by mouth every twelve hours
Nifedipine and Labetalol
DrugNifedipine 60mg by mouth every twelve hours plus Labetalol 200mg by mouth every twelve hours
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Nifedipine and EnalaprilExperimental treatment 1 intervention
Group B: Nifedipine and LabetalolActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Composite postpartum hypertension treatment failure within 6 weeks postpartum
The primary outcome is a binary composite outcome, defined as the occurrence of any one or more of the following events within 6 weeks postpartum: Prolonged hospitalization, Hospital readmission for hypertension, Persistence of hypertension beyond 14 days postpartum, Requirement for acute treatment of severe-range hypertension. Participants experiencing at least one component will be classified as having met the composite outcome.
Time frame
6-weeks postpartumSponsors and contacts
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Source ClinicalTrials.gov