Leg Elevation for Low Blood Pressure During Labor

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether raising the legs can prevent low blood pressure in women receiving an epidural during labor. Participants will either elevate their legs on a peanut ball or not while lying on their side for about 40 minutes. Women planning a vaginal delivery with an epidural at Good Samaritan Hospital who are 37+ weeks pregnant might be suitable candidates. The trial aims to determine if this simple method can manage blood pressure and improve comfort during labor. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance labor experiences for future mothers.

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 prior data suggests that leg elevation is safe for preventing hypotension during labor?

Research shows that raising the legs is generally safe and well-tolerated. Studies have found that it can help prevent low blood pressure during procedures like C-sections without causing major side effects. One study found that raising the legs can reduce the need for medication to control blood pressure. Another study reported that it lowers the risk of low blood pressure after spinal anesthesia. These findings suggest that using leg elevation during labor, especially after an epidural, is unlikely to cause harm and could help manage blood pressure.12345

Why are researchers excited about this trial?

Researchers are excited about the leg elevation technique for managing low blood pressure during labor because it's a simple, non-invasive method that could enhance the comfort and safety of childbirth. Unlike medications typically used to manage low blood pressure, which can have side effects for both mother and baby, this method uses a physical adjustment: elevating the legs on an orange peanut ball. This approach could offer a safe alternative or complement to current treatments, potentially improving outcomes without the need for additional drugs.

What evidence suggests that leg elevation is effective for preventing low blood pressure during labor?

This trial will compare the effects of leg elevation on blood pressure during labor. Research has shown that raising the legs can help prevent low blood pressure during labor, especially after an epidural. Studies have found that lifting the legs can reduce the need for noradrenaline, a medicine that stabilizes blood pressure, during cesarean deliveries. Additional research suggests that raising the legs after spinal anesthesia can significantly lower the risk of low blood pressure, with one study showing about a 53% reduction in risk. Overall, leg elevation is considered a safe and effective method to manage blood pressure during delivery. Participants in this trial will be placed in either the leg elevation arm or the control arm to evaluate these effects.12456

Are You a Good Fit for This Trial?

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.
See 1 more

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.
See 6 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Intervention - Leg Elevation ArmExperimental Treatment1 Intervention
Group II: Control - No Leg Elevation ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

TriHealth Inc.

Lead Sponsor

Trials
103
Recruited
54,100+

Citations

Leg Elevation to Prevent Hypotension During LaborThe 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 ...
The influence of thirty-degree leg elevation on noradrenaline ...The current study demonstrated that passive leg elevation significantly reduces noradrenaline requirements during cesarean delivery under spinal ...
Leg Elevation for Low Blood Pressure During LaborLeg elevation has been studied for preventing low blood pressure during cesarean sections and is generally considered safe for this purpose.
Effectiveness of Leg-Elevation to Prevent Post-Spinal ...A majority of the evidence revealed that leg elevation following spinal anaesthesia in a caesarean delivery was effective in preventing post-spinal-induced ...
Effectiveness of Leg Elevation to Prevent Spinal ...The relative risk of developing postspinal hypotension in the leg elevation group compared to the control group was 0.47 (95% CI, 0.28–1.00).
Lower limbs venous compression reduces the incidence of ...The main result of this study is that LLC with medical stocking (20–36 mmHg) significantly reduced the incidence of maternal hypotensions within 15 min and ...
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