NCT04750486

Lower Limb Compression Prevents Hypotension After Epidural in Labor

Lower Limb Compression Prevents Hypotension After Epidural in Labor: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Wayne State University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to determine whether the use of sequential compression devices (lower limb compression) can reduce the rate of maternal hypotension after epidural, and therefore reduce the incidence of fetal heart tracing complications during labor.

Detailed description

Maternal hypotension during epidural anesthesia in laboring patients can cause a number of problems for both mother and fetus. Despite standard anesthesia protocols designed to minimize the occurrence of hypotension during epidural placement, approximately 30% of laboring patients will still experience clinically significant hypotension. Maternal hypotension can affect placental blood flow causing fetal bradycardia and academia, as well as maternal symptoms such as dizziness, nausea, and vomiting. Therefore, there is a need for improved management of women in labor at time of epidural placement to avoid negative consequences for mother and fetus. We plan to investigate whether the use of lower limb compression devices at the time of epidural would decrease maternal hypotension. Pregnant women who request epidural anesthesia during labor will be recruited and enrolled in this single site, randomized controlled trial. Patients will be randomized into either control or sequential compression device (SCD) groups. Following epidural, blood pressures will be measured at 1, 5, 15, 30, 45, and 60 minutes and rates of hypotension with subsequent fetal heart tracing abnormalities will be recorded.

Conditions

• Labor Pain
• Maternal Hypotension

Interventions

Type	Name	Description
DEVICE	Sequential compression devices	Two lower limb intermittent compression devices to be placed on the mid-calf of each leg.

Timeline

• Start date: 2021-02-05
• Primary completion: 2023-02-15
• Completion: 2023-02-15
• First posted: 2021-02-11
• Last updated: 2023-08-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study