Clinical trial NCT05674838: Leg Elevation to Prevent Hypotension During Labor
Official title: Evaluation of the Use of Leg Elevation on a Peanut Ball to Prevent Hypotension Following Epidural Anesthesia in Laboring Women
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hypotension
Labor Complication
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

Outcome variables include occurrence of maternal hypotension or late or prolonged decelerations within the first hour after epidural placement.

Eligibility criteria: Inclusion Criteria:

* Laboring at Good Samaritan Hospital Labor \& Delivery Unit
* 37+ weeks gestation
* Planned vaginal delivery
* Planned epidural analgesia

Exclusion Criteria:

* Under 18 years old
* Does not speak English
* Unable to consent to involvement in the research study
* Attended less than 3 prenatal care office visits
* Diagnosed with fetal demise
* Diagnosed with fetal anomalies
* Contraindications to both legs being elevated (ex: fractured bones, lower limb amputation, etc.)
* Contraindications to receiving 1L of IV fluids
* Requiring IV hypertensive medications
* Requiring IV magnesium

Primary outcomes:
measure: Maternal Hypotension
timeFrame: 40 minutes
measure: Late or Prolonged Decelerations
timeFrame: 40 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
Study officials:
References: