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Lower Limb Compression Prevents Hypotension After Epidural in Labor

Primary Purpose

Labor Pain, Maternal Hypotension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sequential compression devices
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Labor Pain focused on measuring Epidural anesthesia, Lower extremity compression

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Detroit Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Lower Extremity Compression

Arm Description

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

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

Outcomes

Primary Outcome Measures

Maternal hypotension
Determined by maternal blood pressure measurements.
Maternal hypotension
Determined by maternal blood pressure measurements.
Maternal hypotension
Determined by maternal blood pressure measurements.
Maternal hypotension
Determined by maternal blood pressure measurements.
Maternal hypotension
Determined by maternal blood pressure measurements.
Maternal hypotension
Determined by maternal blood pressure measurements.

Secondary Outcome Measures

Fetal heart rate tracing category
Determination of category I, II or III fetal heart rate tracing.
Delivery method
Vaginal or cesarean delivery ( report)

Full Information

First Posted
January 29, 2021
Last Updated
August 9, 2023
Sponsor
Wayne State University
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1. Study Identification

Unique Protocol Identification Number
NCT04750486
Brief Title
Lower Limb Compression Prevents Hypotension After Epidural in Labor
Official Title
Lower Limb Compression Prevents Hypotension After Epidural in Labor: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 5, 2021 (Actual)
Primary Completion Date
February 15, 2023 (Actual)
Study Completion Date
February 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain, Maternal Hypotension
Keywords
Epidural anesthesia, Lower extremity compression

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization of patients to either control or study groups.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention, the patient will be provided routine care at time of epidural placement without use of sequential compression devices.
Arm Title
Lower Extremity Compression
Arm Type
Experimental
Arm Description
Patients will have sequential compression devices prior to epidural placement, and maintained for at least one hour following procedure.
Intervention Type
Device
Intervention Name(s)
Sequential compression devices
Other Intervention Name(s)
Lower extremity intermittent compression devices
Intervention Description
Two lower limb intermittent compression devices to be placed on the mid-calf of each leg.
Primary Outcome Measure Information:
Title
Maternal hypotension
Description
Determined by maternal blood pressure measurements.
Time Frame
Blood pressures measured at 1 minute following epidural placement.
Title
Maternal hypotension
Description
Determined by maternal blood pressure measurements.
Time Frame
Blood pressures measured at 5 minutes following epidural placement.
Title
Maternal hypotension
Description
Determined by maternal blood pressure measurements.
Time Frame
Blood pressures measured at 15 minutes following epidural placement.
Title
Maternal hypotension
Description
Determined by maternal blood pressure measurements.
Time Frame
Blood pressures measured at 30 minutes following epidural placement.
Title
Maternal hypotension
Description
Determined by maternal blood pressure measurements.
Time Frame
Blood pressures measured at 45 minutes following epidural placement.
Title
Maternal hypotension
Description
Determined by maternal blood pressure measurements.
Time Frame
Blood pressures measured at 60 minutes following epidural placement.
Secondary Outcome Measure Information:
Title
Fetal heart rate tracing category
Description
Determination of category I, II or III fetal heart rate tracing.
Time Frame
Two hours following epidural placement.
Title
Delivery method
Description
Vaginal or cesarean delivery ( report)
Time Frame
length of labor.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Johnson, MD
Organizational Affiliation
Detroit Medical Center/Wayne State University
Official's Role
Study Director
Facility Information:
Facility Name
Detroit Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
3674479
Citation
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.
Results Reference
background
PubMed Identifier
12100826
Citation
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.
Results Reference
background
PubMed Identifier
7091625
Citation
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.
Results Reference
background
PubMed Identifier
17413923
Citation
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.
Results Reference
background

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Lower Limb Compression Prevents Hypotension After Epidural in Labor

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