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Persistent Postpartum Hypertension Pilot Trial

Primary Purpose

Hypertension in Pregnancy

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nifedipine Extended-Release Tablets
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension in Pregnancy

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Duke University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Treatment Group

Control Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Average Systolic Blood Pressure at 1 Week Postpartum

Secondary Outcome Measures

Average Systolic Blood Pressure at 4 Weeks Postpartum
Average Diastolic Blood Pressure at 1 Week Postpartum
Average Diastolic Blood Pressure at 4 Weeks Postpartum
Number of Participants With Blood Pressure < 130/80 mm Hg at 1 Week Postpartum
Number of Participants With Blood Pressure < 130/80 mm Hg at 4 Weeks Postpartum
Method of Feeding
Number of Participants With ED/Triage Visits
Number of Participants With an Increase in Blood Pressure Medication at 1 Week Postpartum
Number of Participants in the no Treatment Group With Initiation of Blood Pressure Medication at 1 Week Postpartum
Number of Participants Who Added a 2nd Blood Pressure Medication at 1 Week Postpartum
Number of Participants With Hospital Readmission

Full Information

First Posted
April 14, 2020
Last Updated
March 7, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT04349124
Brief Title
Persistent Postpartum Hypertension Pilot Trial
Official Title
Pilot Treatment of Persistent Non-Severe Postpartum Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Unable to continue recruiting
Study Start Date
August 25, 2020 (Actual)
Primary Completion Date
February 12, 2021 (Actual)
Study Completion Date
March 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension in Pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Treatment Arm vs Active Control Arm
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Other
Arm 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.
Arm Title
Control Group
Arm Type
No Intervention
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Nifedipine Extended-Release Tablets
Intervention Description
Antihypertensive
Primary Outcome Measure Information:
Title
Average Systolic Blood Pressure at 1 Week Postpartum
Time Frame
1 week postpartum
Secondary Outcome Measure Information:
Title
Average Systolic Blood Pressure at 4 Weeks Postpartum
Time Frame
4 weeks postpartum
Title
Average Diastolic Blood Pressure at 1 Week Postpartum
Time Frame
1 week postpartum
Title
Average Diastolic Blood Pressure at 4 Weeks Postpartum
Time Frame
4 weeks postpartum
Title
Number of Participants With Blood Pressure < 130/80 mm Hg at 1 Week Postpartum
Time Frame
1 week postpartum
Title
Number of Participants With Blood Pressure < 130/80 mm Hg at 4 Weeks Postpartum
Time Frame
4 weeks postpartum
Title
Method of Feeding
Time Frame
up to 4 weeks postpartum
Title
Number of Participants With ED/Triage Visits
Time Frame
up to 4 weeks postpartum
Title
Number of Participants With an Increase in Blood Pressure Medication at 1 Week Postpartum
Time Frame
1 week postpartum
Title
Number of Participants in the no Treatment Group With Initiation of Blood Pressure Medication at 1 Week Postpartum
Time Frame
1 week postpartum
Title
Number of Participants Who Added a 2nd Blood Pressure Medication at 1 Week Postpartum
Time Frame
1 week postpartum
Title
Number of Participants With Hospital Readmission
Time Frame
up to 4 weeks postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brenna Hughes, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Persistent Postpartum Hypertension Pilot Trial

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