Lower Limb Compression Prevents Hypotension After Epidural in Labor

Not Applicable

Completed

• Conditions: Labor Pain; Maternal Hypotension
• Interventions: Device: Sequential compression devices

• Registration Number: NCT04750486
• Lead Sponsor: Wayne State University

Brief 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.

Study Timeline

• Study First Submitted: 2021-01-29
• Study Start: 2021-02-05
• Study First Submitted QC: 2021-02-10
• Study First Posted: 2021-02-11
• Primary Completion: 2023-02-15
• Study Completion: 2023-02-15
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-09
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lower Extremity Compression	Sequential compression devices	Patients will have sequential compression devices prior to epidural placement, and maintained for at least one hour following procedure.

Primary Outcome Measures

Name	Time	Method
Maternal hypotension	Blood pressures measured at 60 minutes following epidural placement.	Determined by maternal blood pressure measurements.

Secondary Outcome Measures

Name	Time	Method
Fetal heart rate tracing category	Two hours following epidural placement.	Determination of category I, II or III fetal heart rate tracing.
Delivery method	length of labor.	Vaginal or cesarean delivery ( report)

Trial Locations

Locations (1)

Detroit Medical Center; 🇺🇸 Detroit, Michigan, United States