Persistent Postpartum Hypertension Pilot Trial

Pilot Treatment of Persistent Non-Severe Postpartum Hypertension

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.

Study Overview

• Status: Terminated
• Conditions: Hypertension in Pregnancy
• Intervention / Treatment: Drug: Nifedipine Extended-Release Tablets

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Drug: Nifedipine Extended-Release Tablets; Antihypertensive
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2020
• Primary Completion (Actual): February 12, 2021
• Study Completion (Actual): March 4, 2021

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (Actual): April 16, 2020

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 7, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications; Hypertension; Hypertension, Pregnancy-Induced; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Nifedipine
• Other Study ID Numbers: Pro00104425

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes