Lower Limb Compression Prevents Hypotension After Epidural in Labor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-05

Study Completion Date

2023-02-15

Brief Summary

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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.

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Detailed Description

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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

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Labor Pain Maternal Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization of patients to either control or study groups.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Lower Extremity Compression

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

Group Type EXPERIMENTAL

Sequential compression devices

Intervention Type DEVICE

Two lower limb intermittent compression devices to be placed on the mid-calf of each leg.

Interventions

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Sequential compression devices

Two lower limb intermittent compression devices to be placed on the mid-calf of each leg.

Intervention Type DEVICE

Other Intervention Names

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Lower extremity intermittent compression devices

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes