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 leg elevation 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 be put in a left tilt position with her hip on a wedge and both legs elevated on a peanut ball. She'll remain in this position for approximately 40 minutes. Arm 2: Patient will be put in a left tilt position with her hip on a wedge and no leg elevation. She'll remain in this position for approximately 40 minutes.
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 leg elevation 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 be put in a left tilt position with her hip on a wedge and both legs elevated on a peanut ball. She'll remain in this position for approximately 40 minutes. Arm 2: Patient will be put in a left tilt position with her hip on a wedge and no leg elevation. She'll remain in this position for approximately 40 minutes. Outcome variables include occurrence of maternal hypotension or late or prolonged decelerations within the first hour after epidural placement.
Interventions
OTHERLeg Elevation
Immediately after epidural placement, patient will be placed in a left tilt position with her hip on a wedge and both of her legs elevated on an orange peanut ball. She will remain in this position for approximately 40 minutes.
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 Good Samaritan Hospital Labor & Delivery Unit * 37+ weeks gestation * Planned vaginal delivery * Planned epidural analgesia
Exclusion criteria
* Under 18 years old * Does not speak English * Unable to consent to involvement in the research study * Attended less than 3 prenatal care office visits * Diagnosed with fetal demise * Diagnosed with fetal anomalies * Contraindications to both legs being elevated (ex: fractured bones, lower limb amputation, etc.) * Contraindications to receiving 1L of IV fluids * Requiring IV hypertensive medications * Requiring IV magnesium
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Maternal Hypotension Requiring Treatment | 40 minutes | SBP requiring treatment by the anesthesia provider |
| Number of Patients With Late or Prolonged Decelerations on the Fetal Heart Tracings | 40 minutes | Any late or prolonged decelerations on the fetal heart tracings |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental Intervention - Leg Elevation Arm Immediately after epidural placement, patient will be placed in a left tilt position with her hip on a wedge and both of her legs elevated on an orange peanut ball. She will remain in this position for approximately 40 minutes. | 54 |
| Control - No Leg Elevation Arm Immediately after epidural placement, patient will be placed in a left tilt position with her hip on a wedge. She will remain in this position for approximately 40 minutes. | 38 |
| Total | 92 |
Baseline characteristics
| Characteristic | Experimental Intervention - Leg Elevation Arm | Control - No Leg Elevation Arm | Total |
|---|---|---|---|
| Age, Continuous | 30.4 years STANDARD_DEVIATION 4.4 | 29.9 years STANDARD_DEVIATION 4.2 | 30.2 years STANDARD_DEVIATION 4.3 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 54 Participants | 38 Participants | 92 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 / 54 | 0 / 38 |
| other Total, other adverse events | 0 / 54 | 0 / 38 |
| serious Total, serious adverse events | 0 / 54 | 0 / 38 |
Outcome results
Primary
Number of Patients With Late or Prolonged Decelerations on the Fetal Heart Tracings
Any late or prolonged decelerations on the fetal heart tracings
Time frame: 40 minutes
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental Intervention - Leg Elevation Arm | Number of Patients With Late or Prolonged Decelerations on the Fetal Heart Tracings | Late or Prolonged Decelerations | 10 Participants |
| Experimental Intervention - Leg Elevation Arm | Number of Patients With Late or Prolonged Decelerations on the Fetal Heart Tracings | No Late or Prolonged Decelerations | 44 Participants |
| Control - No Leg Elevation Arm | Number of Patients With Late or Prolonged Decelerations on the Fetal Heart Tracings | Late or Prolonged Decelerations | 12 Participants |
| Control - No Leg Elevation Arm | Number of Patients With Late or Prolonged Decelerations on the Fetal Heart Tracings | No Late or Prolonged Decelerations | 26 Participants |
Primary
Number of Patients With Maternal Hypotension Requiring Treatment
SBP requiring treatment by the anesthesia provider
Time frame: 40 minutes
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental Intervention - Leg Elevation Arm | Number of Patients With Maternal Hypotension Requiring Treatment | Maternal Hypotension requiring Intervention | 6 Participants |
| Experimental Intervention - Leg Elevation Arm | Number of Patients With Maternal Hypotension Requiring Treatment | No Maternal Hypotension requiring Intervention | 48 Participants |
| Control - No Leg Elevation Arm | Number of Patients With Maternal Hypotension Requiring Treatment | Maternal Hypotension requiring Intervention | 11 Participants |
| Control - No Leg Elevation Arm | Number of Patients With Maternal Hypotension Requiring Treatment | No Maternal Hypotension requiring Intervention | 27 Participants |