NCT05674838

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 29, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 9, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2025

Completed
17 days until next milestone

Results Posted

Study results publicly available

August 29, 2025

Completed
Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

2.6 years

First QC Date

December 21, 2022

Results QC Date

August 12, 2025

Last Update Submit

August 28, 2025

Conditions

HypotensionLabor Complication

Outcome Measures

Primary Outcomes (2)

  • Number of Patients With Maternal Hypotension Requiring Treatment

    SBP requiring treatment by the anesthesia provider

    40 minutes

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

    Any late or prolonged decelerations on the fetal heart tracings

    40 minutes

Study Arms (2)

Experimental Intervention - Leg Elevation Arm

EXPERIMENTAL

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.

Other: Leg Elevation

Control - No Leg Elevation Arm

NO INTERVENTION

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.

Interventions

Leg ElevationOTHER

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.

Experimental Intervention - Leg Elevation Arm

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsLaboring women only
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

HypotensionObstetric Labor Complications

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Results Point of Contact

Title
Nurse Researcher
Organization
TriHealth
Rachel_Baker2@trihealth.com
513-569-6191

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2022

First Posted

January 9, 2023

Study Start

October 29, 2022

Primary Completion

May 29, 2025

Study Completion

August 12, 2025

Last Updated

August 29, 2025

Results First Posted

August 29, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)