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 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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Antihypertensive
Duke University
Durham, North Carolina, United States
Average Systolic Blood Pressure at 1 Week Postpartum
Time frame: 1 week postpartum
Average Systolic Blood Pressure at 4 Weeks Postpartum
Time frame: 4 weeks postpartum
Average Diastolic Blood Pressure at 1 Week Postpartum
Time frame: 1 week postpartum
Average Diastolic Blood Pressure at 4 Weeks Postpartum
Time frame: 4 weeks postpartum
Number of Participants With Blood Pressure < 130/80 mm Hg at 1 Week Postpartum
Time frame: 1 week postpartum
Number of Participants With Blood Pressure < 130/80 mm Hg at 4 Weeks Postpartum
Time frame: 4 weeks postpartum
Method of Feeding
Time frame: up to 4 weeks postpartum
Number of Participants With ED/Triage Visits
Time frame: up to 4 weeks postpartum
Number of Participants With an Increase in Blood Pressure Medication at 1 Week Postpartum
Time frame: 1 week postpartum
Number of Participants in the no Treatment Group With Initiation of Blood Pressure Medication at 1 Week Postpartum
Time frame: 1 week postpartum
Number of Participants Who Added a 2nd Blood Pressure Medication at 1 Week Postpartum
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Time frame: 1 week postpartum
Number of Participants With Hospital Readmission
Time frame: up to 4 weeks postpartum