Lower Limb Compression Prevents Hypotension After Epidural in Labor

Study Overview
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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.

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.

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

Conditions
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Labor Pain, Maternal Hypotension

Intervention / Treatment
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* Device: Sequential compression devices


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization of patients to either control or study groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No intervention, the patient will be provided routine care at time of epidural placement without use of sequential compression devices. | |
| Experimental: Lower Extremity Compression<br>Patients will have sequential compression devices prior to epidural placement, and maintained for at least one hour following procedure. | Device: Sequential compression devices<br>* Two lower limb intermittent compression devices to be placed on the mid-calf of each leg.<br>* Other names: Lower extremity intermittent compression devices;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal hypotension | Determined by maternal blood pressure measurements. | Blood pressures measured at 1 minute following epidural placement. | 
| Maternal hypotension | Determined by maternal blood pressure measurements. | Blood pressures measured at 5 minutes following epidural placement. | 
| Maternal hypotension | Determined by maternal blood pressure measurements. | Blood pressures measured at 15 minutes following epidural placement. | 
| Maternal hypotension | Determined by maternal blood pressure measurements. | Blood pressures measured at 30 minutes following epidural placement. | 
| Maternal hypotension | Determined by maternal blood pressure measurements. | Blood pressures measured at 45 minutes following epidural placement. | 
| Maternal hypotension | Determined by maternal blood pressure measurements. | Blood pressures measured at 60 minutes following epidural placement. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal heart rate tracing category | Determination of category I, II or III fetal heart rate tracing. | Two hours following epidural placement. | 
| Delivery method | Vaginal or cesarean delivery ( report) | length of labor. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidural anesthesia, Lower extremity compression