Skip to main content
Clinical Trials/NCT00443560
NCT00443560CompletedNot Applicable

A Retrospective Case-controlled Study of the Association Between Request to Discontinue Second Stage Labor Epidural Analgesia and Risk of Instrumental Vaginal Delivery

Northwestern University1 site in 1 country2,162 target enrollmentStarted: January 2006Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
2,162
Locations
1
Primary Endpoint
Number of Parturients With a Decrease in the Infusion of Epidural Analgesia During Second Stage of Labor

Study Overview

Brief Summary

The objective of this study will be to compare epidural infusion management, specifically looking at infusion rate changes, in patients who receive forceps deliveries versus normal spontaneous vaginal deliveries. We will match patients based on time and date of delivery, as well as parity, in order to eliminate these variables as potential con-founders.

We hypothesize patients who require a decrease in their basal labor analgesia epidural infusion rate will have an increased incidence of forceps delivery.

Detailed Description

The obstetrical anesthesia database will be queried for all forceps deliveries between the dates of January 2004-October 2005. To minimize the influence of different anesthetic and obstetric care providers, the control group consisted of parturients who has spontaneous vaginal deliveries (SVD) in the same 24 hour period who were case-matched for gravidity and parity. Parturients with twin deliveries and fetal demise were not selected for either group.

The database will be queried for the following: maternal age, parity, gestational age, type of analgesia, changes in epidural infusion rate and/or concentration, and supplemental bolus doses of local anesthesia. The data will be stripped of identification by the database manager and entered into a secured computer which is password protected and maintained in the Department of Anesthesiology. The primary endpoint is to evaluate if decreasing the epidural infusion rate was associated with a forceps delivery.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Singletons
  • Viable fetal vaginal deliveries between January 2004-October 2005

Exclusion Criteria

  • Outside specified time frame
  • Multiparity
  • Fetal demise

Outcomes

Primary Outcomes

Number of Parturients With a Decrease in the Infusion of Epidural Analgesia During Second Stage of Labor

Time Frame: Second stage of labor up to 3 hours

At the request of the obstetric provider, second stage analgesia density was decreased by decreasing the basal infusion rate if there was dissatisfaction with the progress of labor or a perceived inability to push. The basal infusion was never totally discontinued.

Secondary Outcomes

  • Number of Participants With Breakthrough Pain in the First Stage of Labor(Supplemental analgesia in first stage of labor (<24 hours))
  • Duration of Labor Analgesia(Time form initiation of labor analgesia to delivery (up to 24 hours))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Cynthia Wong

Professor of Anesthesiology

Northwestern University

Study Sites (1)

Loading locations...

Similar Trials