HypotensionNCT05674838
Leg Elevation to Prevent Hypotension During Labor
A study testing Leg Elevation in people with Hypotension and Labor Complication, run by TriHealth Inc. at 1 site in United States.
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 leg elevation in preventing hypotension among a larger sample of laboring… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypotension, Labor Complication
- What is being tested?
- Leg Elevation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2022to 12 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Laboring at Good Samaritan Hospital Labor \& Delivery Unit
- 37+ weeks gestation
- Planned vaginal delivery
- Planned epidural analgesia
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Use of Leg Elevation on a Peanut Ball to Prevent Hypotension Following Epidural Anesthesia in Laboring Women
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.
Read the 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.
- Conditions
- Hypotension, Labor Complication
- Being tested
- Leg Elevation
- Medical subject headings
- Hypotension, Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leg ElevationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Intervention - Leg Elevation Arm | Experimental | 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. Receives: Other: Leg Elevation |
| Control - No Leg Elevation Arm | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Maternal Hypotension Requiring Treatment
SBP requiring treatment by the anesthesia provider
Measured: 40 minutes
Number of Patients With Late or Prolonged Decelerations on the Fetal Heart Tracings
Any late or prolonged decelerations on the fetal heart tracings
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start29 Oct 2022
- Primary completion29 May 2025
- Study completion12 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674838
- Sponsor's protocol ID
- 22-045
- Status last verified
- Aug 2025
- First submitted
- 21 Dec 2022
- Last updated
- 29 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of Leg Elevation on a Peanut Ball to Prevent Hypotension Following Epidural Anesthesia in Laboring Women
- ClinicalTrials.gov ID
- NCT05674838
- Acronym / sponsor ID
- 22-045
- Conditions
- Hypotension, Labor Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- 29 Oct 2022 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- 12 Aug 2025 (actual)
- First posted
- 9 Jan 2023 (actual)
- Results
- Posted 29 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Intervention - Leg Elevation Arm | Experimental | Other: Leg ElevationImmediately 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. |
| Control - No Leg Elevation Arm | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Laboring at Good Samaritan Hospital Labor \& Delivery Unit
- 37+ weeks gestation
- Planned vaginal delivery
- Planned epidural analgesia
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leg ElevationImmediately 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. | Other | Experimental Intervention - Leg Elevation Arm |
Primary outcome
Number of Patients With Maternal Hypotension Requiring Treatment
Time frame: 40 minutes
SBP requiring treatment by the anesthesia provider
Number of Patients With Late or Prolonged Decelerations on the Fetal Heart Tracings
Time frame: 40 minutes
Any late or prolonged decelerations on the fetal heart tracings
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Hypotension
Recruiting
Individualised Blood Pressure Targets Versus Standard Care Among Critically Ill Patients With Shock
Critical Illness, Shock
Not yet recruiting
ED90 of Norepinephrine and Phenylephrine Infusion in Patients of Advanced Maternal Age
Adverse Event, Hypotension (MeSH: D007022)
Active, not recruitingObservational study
Effects of Transitional Circulation in ELBW Infants
Neonatal Prematurity, Hypotension
Enrolling by invitationPhase 4
Synthetic Angiotensin II/Giapreza in Pediatric Patients With Refractory Hypotension
Vasodilatory Shock
Active, not recruitingPhase 2
A Study in Subjects With Neurogenic Orthostatic Hypotension
Neurogenic Orthostatic Hypotension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leg Elevation in people with Hypotension and Labor Complication, run by TriHealth Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Maternal Hypotension Requiring Treatment (time frame: 40 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.