NCT04349124

Persistent Postpartum Hypertension Pilot Trial

Pilot Treatment of Persistent Non-Severe Postpartum Hypertension

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension in Pregnancy

Interventions

Type	Name	Description
DRUG	Nifedipine Extended-Release Tablets	Antihypertensive

Timeline

• Start date: 2020-08-25
• Primary completion: 2021-02-12
• Completion: 2021-03-04
• First posted: 2020-04-16
• Last updated: 2023-04-03
• Results posted: 2023-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study