Persistent Postpartum Hypertension Pilot Trial

Phase 4

Terminated

• Conditions: Hypertension in Pregnancy
• Interventions: Drug: Nifedipine Extended-Release Tablets

• Registration Number: NCT04349124
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-16
• Study Start: 2020-08-25
• Primary Completion: 2021-02-12
• Study Completion: 2021-03-04
• Disposition First Submitted: 2022-02-01
• Results First Submitted: 2023-01-06
• Status Verified: 2023-03
• Results First Submitted QC: 2023-03-07
• Last Update Submitted: 2023-03-07
• Results First Posted: 2023-04-03
• Disposition First Posted: 2023-04-03
• Last Update Posted: 2023-04-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 12

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Nifedipine Extended-Release Tablets	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.

Primary Outcome Measures

Name	Time	Method
Average Systolic Blood Pressure at 1 Week Postpartum	1 week postpartum

Secondary Outcome Measures

Name	Time	Method
Average Diastolic Blood Pressure at 4 Weeks Postpartum	4 weeks postpartum
Method of Feeding	up to 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
Number of Participants With ED/Triage Visits	up to 4 weeks 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 With Hospital Readmission	up to 4 weeks postpartum
Average Diastolic Blood Pressure at 1 Week Postpartum	1 week postpartum
Number of Participants With an Increase in Blood Pressure Medication at 1 Week Postpartum	1 week postpartum
Average Systolic Blood Pressure at 4 Weeks Postpartum	4 weeks postpartum
Number of Participants Who Added a 2nd Blood Pressure Medication at 1 Week Postpartum	1 week postpartum

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States