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Leg Elevation to Prevent Hypotension During Labor

Primary Purpose

Hypotension, Labor Complication

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Leg Elevation
Sponsored by
TriHealth Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypotension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Good Samaritan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Intervention - Leg Elevation Arm

Control - No Leg Elevation Arm

Arm Description

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.

Immediately after epidural placement, patient will be placed in a left tilt position with her hip on a wedge. She will remain in this position for approximately 40 minutes.

Outcomes

Primary Outcome Measures

Maternal Hypotension
SBP requiring treatment by the anesthesia provider
Late or Prolonged Decelerations
Any late or prolonged decelerations on the fetal heart tracings

Secondary Outcome Measures

Full Information

First Posted
December 21, 2022
Last Updated
August 3, 2023
Sponsor
TriHealth Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05674838
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 29, 2022 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TriHealth Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension, Labor Complication

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Intervention - Leg Elevation Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control - No Leg Elevation Arm
Arm Type
No Intervention
Arm Description
Immediately after epidural placement, patient will be placed in a left tilt position with her hip on a wedge. She will remain in this position for approximately 40 minutes.
Intervention Type
Other
Intervention Name(s)
Leg Elevation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maternal Hypotension
Description
SBP requiring treatment by the anesthesia provider
Time Frame
40 minutes
Title
Late or Prolonged Decelerations
Description
Any late or prolonged decelerations on the fetal heart tracings
Time Frame
40 minutes

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Laboring women only
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Good Samaritan Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Leg Elevation to Prevent Hypotension During Labor

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