Lower Limb Compression Prevents Hypotension After Epidural in Labor

NCT04750486 | Completed FDA Device

• 1 other identifier: IRB# 20-07-2555
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain; Maternal Hypotension

Keywords

Epidural anesthesia; Lower extremity compression

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Fetal heart rate tracing category

  Two hours following epidural placement.

• Delivery method

  length of labor.

Study Arms (2)

Control

NO INTERVENTION

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

Lower Extremity Compression

EXPERIMENTAL

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

Device: Sequential compression devices

Interventions

Sequential compression devices DEVICE

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

Also known as: Lower extremity intermittent compression devices

Lower Extremity Compression

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Detroit Medical Center

Detroit, Michigan, 48201, United States

Location

Related Publications (4)

• 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.

  PMID: 3674479 BACKGROUND

• 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.

  PMID: 12100826 BACKGROUND

• 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.

  PMID: 7091625 BACKGROUND

• 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.

  PMID: 17413923 BACKGROUND

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffrey Johnson, MD

  Detroit Medical Center/Wayne State University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomization of patients to either control or study groups.

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 11, 2021
• Study Start: February 5, 2021
• Primary Completion: February 15, 2023
• Study Completion: February 15, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)