Effect of Epidural Analgesia During Labor on Force of Maternal Push

Analgesia Clinical Trial

Official title:

Effect of Epidural Analgesia During Labor on Force of Maternal Push

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04888858
• Other study ID #: 14173
• Status: Withdrawn
• Phase: Phase 4
• Start date: November 2, 2020
• Est. completion date: July 2, 2022

Study information

• Verified date: September 2023
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2, 2022
• Est. primary completion date: July 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Labor Pain
• Maternal; Procedure

Intervention

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.

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 hours following initial administration of labor epidural
Secondary	Mode of delivery	Whether the child is delivered via vaginal or cesarean birth.	Up to 72 hours after initial administration of labor epidural
Secondary	Duration of second stage of labor	How long the second stage of labor takes.	Up to 72 hours after initial administration of labor epidural
Secondary	Apgar scores	The apgar scores will be measured.	Up to 72 hours after initial administration of labor epidural