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Effect of Epidural Analgesia During Labor on Force of Maternal Push

Effect of Epidural Analgesia During Labor on Force of Maternal Push

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04888858
Enrollment
0
Registered
2021-05-17
Start date
2020-11-02
Completion date
2022-07-02
Last updated
2023-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Labor Pain, Maternal; Procedure

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.

Interventions

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.

Sponsors

Henry Ford Health System
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

The force of the maternal push when performing Valsalva maneuver will be compared before and after administration of epidural analgesia.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
The change in intraabdominal pressure (surrogate of maternal force)2 hours following initial administration of labor epiduralThe 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

MeasureTime frameDescription
Mode of deliveryUp to 72 hours after initial administration of labor epiduralWhether the child is delivered via vaginal or cesarean birth.
Duration of second stage of laborUp to 72 hours after initial administration of labor epiduralHow long the second stage of labor takes.
Apgar scoresUp to 72 hours after initial administration of labor epiduralThe apgar scores will be measured.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026