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Pre-epidural SCDs to Prevent Hypotension During Labor

Primary Purpose

Hypotension, Labor Complication

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SCD
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 Bethesda North Hospital Labor & Delivery Unit
  • Will receive epidural analgesia
  • 37+ weeks gestation
  • Singleton pregnancy
  • Category 1 tracings only before epidural placement

Exclusion Criteria:

  • Under 18 years old
  • Does not speak English
  • Unable to consent to involvement in the research study
  • Diagnosed with fetal demise
  • Diagnosis of pre-existing hypertension
  • Diagnosis of gestational hypertension
  • Diagnosis of pre-eclampsia
  • Diagnosis of diabetes
  • Breech presentation
  • Contraindications to lower leg compression (ex: fractured bones in leg, cellulitis, lower limb amputation, etc.)
  • Contraindications to receiving 1L of LR
  • Blood pressure on admission SBP>160 or DBP>110
  • Fetal heart rate abnormalities before epidural

Sites / Locations

  • Bethesda North Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention - SCD arm

Control - no SCD arm

Arm Description

Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement

Patient will receive 1L of LR during and after epidural placement with no use of SCDs

Outcomes

Primary Outcome Measures

Hypotension
SBP <90mmHg or an SBP decrease more than 20% from baseline (physiological measure obtained via sphygmomanometer)
Category II tracings
Category II fetal tracings - fetal heart tracings will be reviewed by two independent nurses who will document whether Category II tracings are present or not Category II tracings - The classification of Category II tracings includes the following: bradycardia with variability, tachycardia, minimal variability, no variability with no recurrent decelerations, marked variability, absence of induced accelerations even after fetal stimulation, recurrent variable decelerations with minimal or moderate baseline variability, prolonged decelerations lasting more than two minutes, but less than ten minutes, recurrent late decelerations with moderate variability, variable decelerations with other characteristics such as slow return to baseline, overshooting the baseline, or 'shoulders'

Secondary Outcome Measures

Full Information

First Posted
February 18, 2022
Last Updated
August 3, 2023
Sponsor
TriHealth Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05250960
Brief Title
Pre-epidural SCDs to Prevent Hypotension During Labor
Official Title
Evaluating the Use of Pre-epidural Placement of SCDs to Prevent Hypotension
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 16, 2021 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
March 30, 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
Yes
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 SCDs 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 receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement Arm 2: Patient will receive 1L of LR during and after epidural placement with no use of SCDs
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 SCDs 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 receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement Arm 2: Patient will receive 1L of LR during and after epidural placement with no use of SCDs Outcome variables include occurrence of maternal hypotension or Category II fetal tracings in 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
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention - SCD arm
Arm Type
Experimental
Arm Description
Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement
Arm Title
Control - no SCD arm
Arm Type
No Intervention
Arm Description
Patient will receive 1L of LR during and after epidural placement with no use of SCDs
Intervention Type
Device
Intervention Name(s)
SCD
Intervention Description
Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement
Primary Outcome Measure Information:
Title
Hypotension
Description
SBP <90mmHg or an SBP decrease more than 20% from baseline (physiological measure obtained via sphygmomanometer)
Time Frame
1 hour
Title
Category II tracings
Description
Category II fetal tracings - fetal heart tracings will be reviewed by two independent nurses who will document whether Category II tracings are present or not Category II tracings - The classification of Category II tracings includes the following: bradycardia with variability, tachycardia, minimal variability, no variability with no recurrent decelerations, marked variability, absence of induced accelerations even after fetal stimulation, recurrent variable decelerations with minimal or moderate baseline variability, prolonged decelerations lasting more than two minutes, but less than ten minutes, recurrent late decelerations with moderate variability, variable decelerations with other characteristics such as slow return to baseline, overshooting the baseline, or 'shoulders'
Time Frame
1 hour

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 Bethesda North Hospital Labor & Delivery Unit Will receive epidural analgesia 37+ weeks gestation Singleton pregnancy Category 1 tracings only before epidural placement Exclusion Criteria: Under 18 years old Does not speak English Unable to consent to involvement in the research study Diagnosed with fetal demise Diagnosis of pre-existing hypertension Diagnosis of gestational hypertension Diagnosis of pre-eclampsia Diagnosis of diabetes Breech presentation Contraindications to lower leg compression (ex: fractured bones in leg, cellulitis, lower limb amputation, etc.) Contraindications to receiving 1L of LR Blood pressure on admission SBP>160 or DBP>110 Fetal heart rate abnormalities before epidural
Facility Information:
Facility Name
Bethesda North Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Pre-epidural SCDs to Prevent Hypotension During Labor

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