Lower Limb Compression Prevents Hypotension After Epidural in Labor

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

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.

Study Overview

• Status: Completed
• Conditions: Labor Pain; Maternal Hypotension
• Intervention / Treatment: Device: Sequential compression devices

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 Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Detroit Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Wayne State University
• Investigators: Study Director: Jeffrey Johnson, MD, Detroit Medical Center/Wayne State University

Publications and helpful links

General Publications

• American Society of Anesthesiologists Task Force on Obstetric Anesthesia. Practice guidelines for obstetric anesthesia: an updated report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia. Anesthesiology. 2007 Apr;106(4):843-63. doi: 10.1097/01.anes.0000264744.63275.10. No abstract available.
• Corke BC, Datta S, Ostheimer GW, Weiss JB, Alper MH. Spinal anaesthesia for Caesarean section. The influence of hypotension on neonatal outcome. Anaesthesia. 1982 Jun;37(6):658-62. doi: 10.1111/j.1365-2044.1982.tb01278.x.
• Brizgys RV, Dailey PA, Shnider SM, Kotelko DM, Levinson G. The incidence and neonatal effects of maternal hypotension during epidural anesthesia for cesarean section. Anesthesiology. 1987 Nov;67(5):782-6. doi: 10.1097/00000542-198711000-00025. No abstract available.
• Goetzl LM; ACOG Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin. Clinical Management Guidelines for Obstetrician-Gynecologists Number 36, July 2002. Obstetric analgesia and anesthesia. Obstet Gynecol. 2002 Jul;100(1):177-91. doi: 10.1016/s0029-7844(02)02156-7.

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2021
• Primary Completion (Actual): February 15, 2023
• Study Completion (Actual): February 15, 2023

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (Actual): February 11, 2021

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Epidural anesthesia; Lower extremity compression
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Labor Pain; Hypotension
• Other Study ID Numbers: IRB# 20-07-2555

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes