The Association Between Decreasing Labor Analgesia Epidural Infusion and Forceps Delivery

March 17, 2014 updated by: Cynthia Wong, Northwestern University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

2162

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant Women

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Outside specified time frame
  • Multiparity
  • Fetal demise

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Instrumental Vaginal Delivery (IVD)
Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
Other: Case controlled analysis of epidural labor analgesia patterns
A retrospective study utilizing the Obstetric Anesthesiology Database to identify parturients who received neuraxial labor analgesia initiated with a combined spinal epidural (CSE) technique and maintained with a continuous epidural infusion with patient controlled epidural analgesia boluses
Other Names:
  • bupivacaine
  • fentanyl
  • combined spinal epidural analgesia
  • epidural labor analgesia
Spontaneous Vaginal Delivery (SVD)
The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity.
Other: Case controlled analysis of epidural labor analgesia patterns
A retrospective study utilizing the Obstetric Anesthesiology Database to identify parturients who received neuraxial labor analgesia initiated with a combined spinal epidural (CSE) technique and maintained with a continuous epidural infusion with patient controlled epidural analgesia boluses
Other Names:
  • bupivacaine
  • fentanyl
  • combined spinal epidural analgesia
  • epidural labor analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Second stage of labor up to 3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Breakthrough Pain in the First Stage of Labor
Time Frame: Supplemental analgesia in first stage of labor (<24 hours)
Pain not responding to epidural analgesia in the first stage of labor was treated with bolus dose of bupivacaine 1.25 mg/mL or lidocaine 10 mg/mL, 10 to 15 mL. If pain relief was obtained the infusion concentration was increased. If the patient had no pain relief following the bolus injection, the epidural catheter was replaced.
Supplemental analgesia in first stage of labor (<24 hours)
Duration of Labor Analgesia
Time Frame: Time form initiation of labor analgesia to delivery (up to 24 hours)
Time in minutes from initiation of labor analgesia until delivery of the infant
Time form initiation of labor analgesia to delivery (up to 24 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Cynthia A Wong, M.D., Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

March 2, 2007

First Submitted That Met QC Criteria

March 5, 2007

First Posted (Estimate)

March 6, 2007

Study Record Updates

Last Update Posted (Estimate)

April 14, 2014

Last Update Submitted That Met QC Criteria

March 17, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0524-028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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