Persistent Postpartum Hypertension Pilot Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Treatment of Persistent Non-Severe Postpartum Hypertension

Conditions
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Hypertension in Pregnancy

Intervention / Treatment
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* Drug: Nifedipine Extended-Release Tablets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Treatment Arm vs Active Control Arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment Group<br>The treatment group will be provided with month supply of 30mg tablets of nifedipine extended release prior to discharge from the delivery admission. Dose increases in clinic will be at the discretion of providers, however a treatment algorithm will be provided for guidance.Treatment group will be given a home blood pressure cuff prior to discharge with instructions for use. They will also be scheduled for a 1 week blood pressure check and 4 week postpartum clinic appointment which standard for these patients outside of this proposal. | Drug: Nifedipine Extended-Release Tablets<br>* Antihypertensive<br>|
| No Intervention: Control Group<br>The control group will not receive any medications at discharge. Providers will be instructed to only prescribe new blood pressure medication at subsequent postpartum visits if the blood pressure is in the severe range (>/=160/110). The control group will be given a home blood pressure cuff prior to discharge with instructions for use. They will also be scheduled for a 1 week blood pressure check and 4 week postpartum clinic appointment which standard for these patients outside of this proposal. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Systolic Blood Pressure at 1 Week Postpartum |  | 1 week postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Systolic Blood Pressure at 4 Weeks Postpartum |  | 4 weeks postpartum | 
| Average Diastolic Blood Pressure at 1 Week Postpartum |  | 1 week postpartum | 
| Average Diastolic Blood Pressure at 4 Weeks Postpartum |  | 4 weeks postpartum | 
| Number of Participants With Blood Pressure < 130/80 mm Hg at 1 Week Postpartum |  | 1 week postpartum | 
| Number of Participants With Blood Pressure < 130/80 mm Hg at 4 Weeks Postpartum |  | 4 weeks postpartum | 
| Method of Feeding |  | up to 4 weeks postpartum | 
| Number of Participants With ED/Triage Visits |  | up to 4 weeks postpartum | 
| Number of Participants With an Increase in Blood Pressure Medication at 1 Week Postpartum |  | 1 week postpartum | 
| Number of Participants in the no Treatment Group With Initiation of Blood Pressure Medication at 1 Week Postpartum |  | 1 week postpartum | 
| Number of Participants Who Added a 2nd Blood Pressure Medication at 1 Week Postpartum |  | 1 week postpartum | 
| Number of Participants With Hospital Readmission |  | up to 4 weeks postpartum |