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Effect of Epidural Analgesia During Labor on Force of Maternal Push

Primary Purpose

Labor Pain, Analgesia, Maternal; Procedure

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Epidural analgesia (0.125% bupivacaine/2mcg fentanyl solution)
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Labor Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult (18 years and older)
  • Pregnant women in their third trimester
  • Able to read and speak English
  • Capacity to consent to participate
  • Receiving a labor epidural catheter during their labor and delivery at HFH-Main

Exclusion Criteria:

  • Severe cardiac disease
  • People who are unable/medically recommended not to perform valsalva maneuvers
  • People who are not undergoing labor epidural analgesia

Sites / Locations

  • Henry Ford Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Epidural Analgesia

Arm Description

All subjects will be given epidural analgesia to treat their labor pain. As part of standard protocol for all patients who receive a labor epidural, the epidural will then be tested using 3ml of 1.5% lidocaine and 1:200,000 epinephrine test solution, and the epidural catheter will then be loaded with 10ml of 0.125% bupivacaine solution. The epidural catheter will then be connected to a programmed intermittent epidural bolus pump which will administer 5ml of a 0.125% bupivacaine/2mcg fentanyl solution every 30minutes. The first dose will be given following 30minutes after the loading dose. 30 minutes after loading the loading dose and after the first pump dose has been given, we will assess the VAS pain scores and the level of the analgesic based on decreased sensation to ice.

Outcomes

Primary Outcome Measures

The change in intraabdominal pressure (surrogate of maternal force)
The change in intraabdominal pressure will be measured prior to receiving epidural analgesia, and again at 1 and 2 hours following administration. The change observed before and after will be compared to quantify the decreased change following epidural administration.

Secondary Outcome Measures

Mode of delivery
Whether the child is delivered via vaginal or cesarean birth.
Duration of second stage of labor
How long the second stage of labor takes.
Apgar scores
The apgar scores will be measured.

Full Information

First Posted
May 6, 2021
Last Updated
September 21, 2023
Sponsor
Henry Ford Health System
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1. Study Identification

Unique Protocol Identification Number
NCT04888858
Brief Title
Effect of Epidural Analgesia During Labor on Force of Maternal Push
Official Title
Effect of Epidural Analgesia During Labor on Force of Maternal Push
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Withdrawn
Why Stopped
The PI, Dr. Younger, left Henry Ford Health.
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
July 2, 2022 (Actual)
Study Completion Date
July 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System

4. Oversight

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

5. Study Description

Brief Summary
There are multiple factors that determine progress of normal vaginal delivery. Frequency, duration and strength of uterine contractions are important for progress throughout labor, and abdominal wall muscle contractions contribute to progress during the final stage. Epidural analgesia helps to alleviate the pain associated with uterine contractions, this however this comes at the expense of prolonging labor by reducing the strength of abdominal wall muscle contractions. The purpose of this prospective study is to quantify how much epidurals decrease the strength of abdominal wall contractions. Intraabdominal pressure will be used as surrogate to strength of abdominal wall contractions, and it will be measured via a foley catheter inserted into the urinary bladder as part of standard procedure for patients receiving labor epidurals. We will compare the change in intraabdominal pressure when patients perform forceful abdominal contractions (valsalva maneuvers) prior to and during epidural analgesia. This will lay the foundation for a future study in which we plan to compare the effects of different epidural analgesia types and concentrations on abdominal wall muscle contractions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain, Analgesia, Maternal; Procedure

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
The force of the maternal push when performing Valsalva maneuver will be compared before and after administration of epidural analgesia.
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epidural Analgesia
Arm Type
Experimental
Arm Description
All subjects will be given epidural analgesia to treat their labor pain. As part of standard protocol for all patients who receive a labor epidural, the epidural will then be tested using 3ml of 1.5% lidocaine and 1:200,000 epinephrine test solution, and the epidural catheter will then be loaded with 10ml of 0.125% bupivacaine solution. The epidural catheter will then be connected to a programmed intermittent epidural bolus pump which will administer 5ml of a 0.125% bupivacaine/2mcg fentanyl solution every 30minutes. The first dose will be given following 30minutes after the loading dose. 30 minutes after loading the loading dose and after the first pump dose has been given, we will assess the VAS pain scores and the level of the analgesic based on decreased sensation to ice.
Intervention Type
Drug
Intervention Name(s)
Epidural analgesia (0.125% bupivacaine/2mcg fentanyl solution)
Intervention Description
As part of standard protocol for all patients who receive a labor epidural, the epidural will then be tested using 3ml of 1.5% lidocaine and 1:200,000 epinephrine test solution, and the epidural catheter will then be loaded with 10ml of 0.125% bupivacaine solution. The epidural catheter will then be connected to a programmed intermittent epidural bolus pump which will administer 5ml of a 0.125% bupivacaine/2mcg fentanyl solution every 30minutes. The first dose will be given following 30minutes after the loading dose. 30 minutes after loading the loading dose and after the first pump dose has been given, we will assess the VAS pain scores and the level of the analgesic based on decreased sensation to ice.
Primary Outcome Measure Information:
Title
The change in intraabdominal pressure (surrogate of maternal force)
Description
The change in intraabdominal pressure will be measured prior to receiving epidural analgesia, and again at 1 and 2 hours following administration. The change observed before and after will be compared to quantify the decreased change following epidural administration.
Time Frame
2 hours following initial administration of labor epidural
Secondary Outcome Measure Information:
Title
Mode of delivery
Description
Whether the child is delivered via vaginal or cesarean birth.
Time Frame
Up to 72 hours after initial administration of labor epidural
Title
Duration of second stage of labor
Description
How long the second stage of labor takes.
Time Frame
Up to 72 hours after initial administration of labor epidural
Title
Apgar scores
Description
The apgar scores will be measured.
Time Frame
Up to 72 hours after initial administration of labor epidural

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Patients must be healthy pregnant women that have reached the decision to receive epidural analgesia for their labor.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult (18 years and older) Pregnant women in their third trimester Able to read and speak English Capacity to consent to participate Receiving a labor epidural catheter during their labor and delivery at HFH-Main Exclusion Criteria: Severe cardiac disease People who are unable/medically recommended not to perform valsalva maneuvers People who are not undergoing labor epidural analgesia
Facility Information:
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to share individual participant data with other researchers.

Learn more about this trial

Effect of Epidural Analgesia During Labor on Force of Maternal Push

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