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Leg Elevation for Low Blood Pressure During Labor
N/A
Waitlist Available
Research Sponsored by TriHealth Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Planned epidural analgesia
37+ weeks gestation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 40 minutes
Awards & highlights
Study Summary
This trial will test if leg elevation can reduce hypotension in pregnant women who receive an epidural.
Who is the study for?
This trial is for women over 18, in labor at Good Samaritan Hospital, planning a vaginal delivery with an epidural, and are at least 37 weeks pregnant. It's not for those needing IV blood pressure meds, speak only non-English languages, have had less than three prenatal visits or certain health conditions like bone fractures.Check my eligibility
What is being tested?
The study tests if elevating both legs on a peanut ball after getting an epidural can prevent low blood pressure. Women will be randomly assigned to either have their legs elevated or not while lying with a hip wedge for about 40 minutes.See study design
What are the potential side effects?
There may be minimal side effects from the leg elevation itself; however, typical risks associated with receiving an epidural such as backache, headache or difficulty urinating might still occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for pain relief through an epidural.
Select...
I am over 37 weeks pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 40 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~40 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Late or Prolonged Decelerations
Maternal Hypotension
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Intervention - Leg Elevation ArmExperimental Treatment1 Intervention
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.
Group II: Control - No Leg Elevation ArmActive Control1 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.
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Who is running the clinical trial?
TriHealth Inc.Lead Sponsor
97 Previous Clinical Trials
53,288 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot receive 1 liter of IV fluids due to health reasons.I am unable to give consent for research participation.I need medicine through an IV to control my high blood pressure.I am under 18 years old.You are planning to give birth through the vagina.I am scheduled for pain relief through an epidural.You have been diagnosed with a nonviable pregnancy.I am over 37 weeks pregnant.You are unable to have both legs elevated, for example if you have broken bones or have had a lower limb amputation.I do not speak English.My unborn baby has been diagnosed with anomalies.I need IV magnesium.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Intervention - Leg Elevation Arm
- Group 2: Control - No Leg Elevation Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants currently enrolling in this trial?
"As per the information available on clinicaltrials.gov, this specific medical trial is not taking in any new patients at present. It was initially posted online on October 29th 2022 and last updated a few months later, December 21st 2022. Fortunately, there are 118 other trails that are still looking for volunteers to participate in their trials."
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