Clinical trial NCT05250960: Pre-epidural Sequential Compression Devices (SCDs) to Prevent Hypotension During Labor
Official title: Evaluating the Use of Pre-epidural Placement of Sequential Compression Devices (SCD) to Prevent Hypotension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension
Labor Complication
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 109
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 1liter (L) of lactated ringers (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.

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 systolic blood pressure (SBP)\>160 or diastolic blood pressure (DBP)\>110
* Fetal heart rate abnormalities before epidural

Primary outcomes:
measure: Hypotension
timeFrame: 1 hour
measure: Category II Tracings
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Bethesda North Hospital
state: Ohio
Study officials:
References: