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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05250960
Other study ID # 21-020
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
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 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

Study Design


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
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