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NCT04349124 Clinical Trial

Persistent Postpartum Hypertension Pilot Trial

Hypertension in Pregnancy Clinical Trial

Official title:
Pilot Treatment of Persistent Non-Severe Postpartum Hypertension

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04349124
Other study ID # Pro00104425
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date August 25, 2020
Est. completion date March 4, 2021

Study information
Verified date March 2023
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 12
Est. completion date March 4, 2021
Est. primary completion date February 12, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Nifedipine Extended-Release Tablets
Antihypertensive

Locations
Country Name City State
United States Duke University Durham North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Average Systolic Blood Pressure at 1 Week Postpartum 1 week postpartum
Secondary Average Systolic Blood Pressure at 4 Weeks Postpartum 4 weeks postpartum
Secondary Average Diastolic Blood Pressure at 1 Week Postpartum 1 week postpartum
Secondary Average Diastolic Blood Pressure at 4 Weeks Postpartum 4 weeks postpartum
Secondary Number of Participants With Blood Pressure < 130/80 mm Hg at 1 Week Postpartum 1 week postpartum
Secondary Number of Participants With Blood Pressure < 130/80 mm Hg at 4 Weeks Postpartum 4 weeks postpartum
Secondary Method of Feeding up to 4 weeks postpartum
Secondary Number of Participants With ED/Triage Visits up to 4 weeks postpartum
Secondary Number of Participants With an Increase in Blood Pressure Medication at 1 Week Postpartum 1 week postpartum
Secondary Number of Participants in the no Treatment Group With Initiation of Blood Pressure Medication at 1 Week Postpartum 1 week postpartum
Secondary Number of Participants Who Added a 2nd Blood Pressure Medication at 1 Week Postpartum 1 week postpartum
Secondary Number of Participants With Hospital Readmission up to 4 weeks postpartum
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Active, not recruiting NCT03648645 - Hypertensive Pregnant Women Monitored by Teletransmitted Self-measurements of Blood Pressure N/A