N/A
N=102
Leg Elevation to Prevent Hypotension During Labor
Hypotension · Labor Complication
Bottom Line
View on ClinicalTrials.gov: NCT05674838 ↗Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Number of Patients With Maternal Hypotension Requiring Treatment — 6; 11; 48; 27 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Leg Elevation (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- TriHealth Inc.
- Primary completion
- May 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Maternal Hypotension Requiring Treatment |
6; 11; 48; 27 | — |
| PRIMARY Number of Patients With Late or Prolonged Decelerations on the Fetal Heart Tracings |
10; 12; 44; 26 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05674838). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.