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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05674838). StuddyBuddy aggregates publicly available trial information.