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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05674838
Other study ID # 22-045
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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