Status:
TERMINATED
Persistent Postpartum Hypertension Pilot Trial
Lead Sponsor:
Duke University
Conditions:
Hypertension in Pregnancy
Eligibility:
FEMALE
18-60 years
Phase:
PHASE4
Brief Summary
This study is a pilot, open-label, randomized controlled trial of postpartum women with hypertensive disorders pregnancy and persistent non-severe blood pressure. The purpose of the study to provide d...
Detailed Description
Study groups will include a treatment with nifedipine extended release or no treatment. Subjects will be randomized 1:1. Subjects randomized to the treatment group will be provided the study drug (nif...
Eligibility Criteria
Inclusion
- Antepartum diagnosis of gestational hypertension
- preeclampsia
- superimposed preeclampsia without antepartum chronic hypertension medication
- Delivery at 23 weeks or greater
- Persistent elevation in BP \>24 hours postpartum (\>140/90 mm Hg) (2 or more BP \>4 hours apart)
- 18 years or older
- English speaking
Exclusion
- Need for continuation of antepartum antihypertensive medication
- Contraindication of calcium channel blocker use
- Severe range (160/110 mm Hg) blood pressure requiring treatment \>24 hours after delivery
- Requires a 2nd oral antihypertensive medication for blood pressure control inpatient
- Acute cardiomyopathy or heart failure
- Creatinine ≥1.5
- Blood pressure \<90/60 within 24 hours of discharge
Key Trial Info
Start Date :
August 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04349124
Start Date
August 25 2020
End Date
March 4 2021
Last Update
April 3 2023
Active Locations (1)
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1
Duke University
Durham, North Carolina, United States, 27705