Leg Elevation for Low Blood Pressure During Labor

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: TriHealth Inc.

Must not be taking: IV hypertensives, IV magnesium

Disqualifiers: Under 18, Fetal demise, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 40 minutes

300 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you require IV hypertensive medications or IV magnesium, you cannot participate.

What data supports the effectiveness of the treatment Leg Elevation for low blood pressure during labor?

Research shows that leg elevation can help reduce low blood pressure after spinal anesthesia in cesarean sections, suggesting it might also help during labor. However, leg elevation alone was not as effective as when combined with leg wrapping. ^{1 2 3 4 5}

Is leg elevation safe for preventing low blood pressure during labor?

Leg elevation has been studied for preventing low blood pressure during cesarean sections and is generally considered safe for this purpose. ^{2 4 6 7 8}

How does the treatment of leg elevation for low blood pressure during labor differ from other treatments?

Leg elevation is a simple, non-invasive treatment that involves raising the legs to help prevent low blood pressure during labor, which is different from other treatments like medication. It is unique because it uses gravity to improve blood flow back to the heart, potentially reducing the need for drugs to manage blood pressure. ^{1 2 3 4 9}

Eligibility Criteria

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.

Inclusion Criteria

Laboring at Good Samaritan Hospital Labor & Delivery Unit

You are planning to give birth through the vagina.

I am scheduled for pain relief through an epidural.

Exclusion 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive epidural anesthesia and are placed in a left tilt position with or without leg elevation for 40 minutes

40 minutes

Follow-up

Participants are monitored for maternal hypotension and fetal heart decelerations after treatment

1 hour

Treatment Details

Interventions

• Leg Elevation

Trial Overview 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.

Participant Groups

Group I: Experimental Intervention - Leg Elevation Arm Experimental Treatment 1 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 Arm Active Control 1 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 Is Running the Clinical Trial?

TriHealth Inc.

Lead Sponsor

Trials

103

Recruited

54,100+

References

1. England pubmed.ncbi.nlm.nih.gov

Leg elevation and wrapping in the prevention of hypotension following spinal anaesthesia for elective caesarean section. [2022]

2. Ireland pubmed.ncbi.nlm.nih.gov

Lower limbs venous compression reduces the incidence of maternal hypotension following epidural analgesia during term labor. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Prevention of post-spinal hypotension at elective cesarean section by wrapping of the lower limbs. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Leg elevation decreases the incidence of post-spinal hypotension in cesarean section: a randomized controlled trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Maternal position during labor: effects on fetal oxygen saturation measured by pulse oximetry. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Leg Elevation to Prevent Spinal Anesthesia-Induced Hypotension during Cesarean Delivery in the Resource-Limited Area: Open Randomized Controlled Trial. [2022]

7. Ireland pubmed.ncbi.nlm.nih.gov

Squatting position in the second stage of labor: A systematic review and meta-analysis. [2022]

8. England pubmed.ncbi.nlm.nih.gov

The risk factors for labor onset hypertension. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Response to a Valsalva manoeuvre before and after epidural block. [2019]