Hypotension, Labor Complication
Conditions
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.
Interventions
DEVICESCD
Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement
Sponsors
TriHealth Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypotension | 1 hour | SBP \<90mmHg or an SBP decrease more than 20% from baseline (physiological measure obtained via sphygmomanometer) |
| Category II Tracings | 1 hour | 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' |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention - SCD Arm Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement
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 | 53 |
| Control - no SCD Arm Patient will receive 1L of LR during and after epidural placement with no use of SCDs | 56 |
| Total | 109 |
Baseline characteristics
| Characteristic | Control - no SCD Arm | Total | Intervention - SCD Arm |
|---|---|---|---|
| Age, Continuous | 28.5 years | 28.8 years | 29.1 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 56 participants | 109 participants | 53 participants |
| Sex: Female, Male Female | 56 Participants | 109 Participants | 53 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 56 |
| other Total, other adverse events | 0 / 53 | 0 / 56 |
| serious Total, serious adverse events | 0 / 53 | 0 / 56 |
Outcome results
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'
Time frame: 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention - SCD Arm | Category II Tracings | 17 Participants |
| Control - no SCD Arm | Category II Tracings | 13 Participants |
Primary
Hypotension
SBP \<90mmHg or an SBP decrease more than 20% from baseline (physiological measure obtained via sphygmomanometer)
Time frame: 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention - SCD Arm | Hypotension | 4 participants |
| Control - no SCD Arm | Hypotension | 4 participants |