Lower Limb Compression Prevents Hypotension After Epidural in Labor

Wayne State University

Status: Completed

Conditions: Labor Pain; Maternal Hypotension

Treatments: Device: Sequential compression devices

Study type: Interventional

Funder types: Other

Identifiers

NCT04750486

IRB# 20-07-2555

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women with pregnancy at term (greater than or equal to 37 weeks 0 days gestation)
• Singleton gestation
• In labor (spontaneous or induced)
• Requested epidural for pain management

Exclusion criteria

• Any diagnosis of hypertension or cardiovascular disease
• Any contraindications to lower extremity compression including deep venous thrombosis in past 6 months, infected leg wound, or deformity of lower extremity
• Any contraindications to epidural placement including severe thrombocytopenia and spinal deformity

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Control

No Intervention group

Description:

No intervention, the patient will be provided routine care at time of epidural placement without use of sequential compression devices.

Lower Extremity Compression

Experimental group

Description:

Patients will have sequential compression devices prior to epidural placement, and maintained for at least one hour following procedure.

Treatment:

Device: Sequential compression devices