Effect of Epidural Analgesia During Labor on Force of Maternal Push

Sponsor
Henry Ford Health System (Other)
Overall Status
Recruiting
CT.gov ID
NCT04888858
Collaborator
(none)
34
1
1
38
0.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Epidural analgesia (0.125% bupivacaine/2mcg fentanyl solution)
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
The force of the maternal push when performing Valsalva maneuver will be compared before and after administration of epidural analgesia.The force of the maternal push when performing Valsalva maneuver will be compared before and after administration of epidural analgesia.
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Effect of Epidural Analgesia During Labor on Force of Maternal Push
Actual Study Start Date :
Nov 2, 2020
Anticipated Primary Completion Date :
Nov 2, 2023
Anticipated Study Completion Date :
Jan 2, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Epidural Analgesia

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.

Drug: Epidural analgesia (0.125% bupivacaine/2mcg fentanyl solution)
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.

Outcome Measures

Primary Outcome Measures

  1. The change in intraabdominal pressure (surrogate of maternal force) [2 hours following initial administration of labor epidural]

    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

  1. Mode of delivery [Up to 72 hours after initial administration of labor epidural]

    Whether the child is delivered via vaginal or cesarean birth.

  2. Duration of second stage of labor [Up to 72 hours after initial administration of labor epidural]

    How long the second stage of labor takes.

  3. Apgar scores [Up to 72 hours after initial administration of labor epidural]

    The apgar scores will be measured.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Henry Ford Hospital Detroit Michigan United States 48202

Sponsors and Collaborators

  • Henry Ford Health System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Joshua Younger, Senior Staff Anesthesiologist, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT04888858
Other Study ID Numbers:
  • 14173
First Posted:
May 17, 2021
Last Update Posted:
Mar 10, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2022