Pre-epidural SCDs to Prevent Hypotension During Labor

Hypotension Clinical Trial

Official title:

Evaluating the Use of Pre-epidural Placement of SCDs to Prevent Hypotension

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05250960
• Other study ID #: 21-020
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 16, 2021
• Est. completion date: March 30, 2024

Study information

• Verified date: February 2024
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• 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 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: March 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Labor Complication
• Obstetric Labor Complications

Intervention

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

Locations

Country	Name	City	State
United States	Bethesda North 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	Hypotension	SBP <90mmHg or an SBP decrease more than 20% from baseline (physiological measure obtained via sphygmomanometer)	1 hour
Primary	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'	1 hour