Leg Elevation to Prevent Hypotension During Labor

Hypotension Clinical Trial

Official title:

Evaluation of the Use of Leg Elevation on a Peanut Ball to Prevent Hypotension Following Epidural Anesthesia in Laboring Women

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05674838
• Other study ID #: 22-045
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 29, 2022
• Est. completion date: March 1, 2025

Study information

• Verified date: February 2024
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: March 1, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Labor Complication
• Obstetric Labor Complications

Intervention

Other:
• Leg Elevation
Immediately after epidural placement, patient will be placed in a left tilt position with her hip on a wedge and both of her legs elevated on an orange peanut ball. She will remain in this position for approximately 40 minutes.

Locations

Country	Name	City	State
United States	Good Samaritan Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal Hypotension	SBP requiring treatment by the anesthesia provider	40 minutes
Primary	Late or Prolonged Decelerations	Any late or prolonged decelerations on the fetal heart tracings	40 minutes