Persistent Postpartum Hypertension Pilot Trial

Duke University

Status and phase: Terminated; Phase 4

Conditions: Hypertension in Pregnancy

Treatments: Drug: Nifedipine Extended-Release Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT04349124

Pro00104425

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Treatment Group

Other group

Description:

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.

Treatment:

Drug: Nifedipine Extended-Release Tablets

Control Group

No Intervention group

Description:

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.