← Back to all trials
Enrolling By Invitation
NCT05674838
Leg Elevation to Prevent Hypotension During Labor
Conditions: Hypotension, Labor Complication
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 300
Sponsor: TriHealth Inc.
Location: United States
Summary
When hypotension is related to epidural placement, this can occur within 15-60 minutes after placement.
The purpose of this study is to build upon this preliminary work and to use a randomized controlled trial to examine the effectiveness of leg elevation in preventing hypotension among a larger sample of laboring women who receive an epidural analgesia.
This study will use a randomized, non-blinded, controlled design with two arms:Arm 1: Patient will be put in a left tilt position with her hip on a wedge and both legs elevated on a peanut ball.
She'll remain in this position for approximately 40 minutes.Arm 2: Patient will be put in a left tilt position with her hip on a wedge and no leg elevation.
She'll remain in this position for approximately 40 minutes.
Eligibility Criteria
Inclusion Criteria:Laboring at Good Samaritan Hospital Labor & Delivery Unit37+ weeks gestationPlanned vaginal deliveryPlanned epidural analgesiaExclusion Criteria:Under 18 years oldDoes not speak EnglishUnable to consent to involvement in the research studyAttended less than 3 prenatal care office visitsDiagnosed with fetal demiseDiagnosed with fetal anomaliesContraindications to both legs being elevated (ex: fractured bones, lower limb amputation, etc.)Contraindications to receiving 1L of IV fluidsRequiring IV hypertensive medicationsRequiring IV magnesium
Source: ClinicalTrials.gov (NCT05674838). StuddyBuddy aggregates publicly available trial information.