Persistent Postpartum Hypertension Pilot Trial

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-25

Study Completion Date

2021-03-04

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.

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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.

Conditions

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Hypertension in Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Treatment Arm vs Active Control Arm

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Group

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.

Group Type OTHER

Nifedipine Extended-Release Tablets

Intervention Type DRUG

Antihypertensive

Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nifedipine Extended-Release Tablets

Antihypertensive

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No