Skip to main content
OpenTrials
Completed

NCT Number: NCT05674838

Leg Elevation to Prevent Hypotension During Labor

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

leg elevation

Other

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 outcomes

  1. Number of Patients With Maternal Hypotension Requiring Treatment

    Time frame: 40 minutes

    SBP requiring treatment by the anesthesia provider

  2. Number of Patients With Late or Prolonged Decelerations on the Fetal Heart Tracings

    Time frame: 40 minutes

    Any late or prolonged decelerations on the fetal heart tracings

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 9, 2023
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.