Clinical trial NCT04349124: Persistent Postpartum Hypertension Pilot Trial
Official title: Pilot Treatment of Persistent Non-Severe Postpartum Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hypertension in Pregnancy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment Arm vs Active Control Arm
Primary purpose: TREATMENT

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 data that may provide guidance regarding blood pressure management of patients with non-severe postpartum hypertension. There are limited guidelines for best practice with persistent, non-severe hypertension, and treatment in this situation is usually at the provider's discretion.

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 (nifedipine extended release) at an initial dose of 30mg daily in 1-month supply. The control group will not receive any drug for blood pressure control. the primary outcome is systolic blood pressure at 1 week postpartum.

Subjects in both groups will be scheduled for a 1-week postpartum blood pressure check and routine 4 week postpartum visit. Medication compliance in the treatment group will be assessed via validated questionnaire. The primary outcome of this study is average systolic blood pressure at 1 week postpartum. Patients will be given instructions on blood pressure ranges and specific symptoms when they should contact study staff.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Average Systolic Blood Pressure at 1 Week Postpartum
timeFrame: 1 week postpartum
Secondary outcomes:
measure: Average Systolic Blood Pressure at 4 Weeks Postpartum
timeFrame: 4 weeks postpartum
measure: Average Diastolic Blood Pressure at 1 Week Postpartum
timeFrame: 1 week postpartum
measure: Average Diastolic Blood Pressure at 4 Weeks Postpartum
timeFrame: 4 weeks postpartum
measure: Number of Participants With Blood Pressure < 130/80 mm Hg at 1 Week Postpartum
timeFrame: 1 week postpartum
measure: Number of Participants With Blood Pressure < 130/80 mm Hg at 4 Weeks Postpartum
timeFrame: 4 weeks postpartum
measure: Method of Feeding
timeFrame: up to 4 weeks postpartum
measure: Number of Participants With ED/Triage Visits
timeFrame: up to 4 weeks postpartum
measure: Number of Participants With an Increase in Blood Pressure Medication at 1 Week Postpartum
timeFrame: 1 week postpartum
measure: Number of Participants in the no Treatment Group With Initiation of Blood Pressure Medication at 1 Week Postpartum
timeFrame: 1 week postpartum
measure: Number of Participants Who Added a 2nd Blood Pressure Medication at 1 Week Postpartum
timeFrame: 1 week postpartum
measure: Number of Participants With Hospital Readmission
timeFrame: up to 4 weeks postpartum
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Brenna Hughes, MD
role: PRINCIPAL_INVESTIGATOR
References: