The Association Between Decreasing Labor Analgesia Epidural Infusion and Forceps Delivery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cynthia Wong, Northwestern University
ClinicalTrials.gov Identifier:
NCT00443560
First received: March 2, 2007
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Labor Pain
Pregnancy
Other: Case controlled analysis of epidural labor analgesia patterns

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: A Retrospective Case-controlled Study of the Association Between Request to Discontinue Second Stage Labor Epidural Analgesia and Risk of Instrumental Vaginal Delivery

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Number of Participants With Breakthrough Pain in the First Stage of Labor [ Time Frame: Supplemental analgesia in first stage of labor (<24 hours) ] [ Designated as safety issue: No ]
    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.

  • Duration of Labor Analgesia [ Time Frame: Time form initiation of labor analgesia to delivery (up to 24 hours) ] [ Designated as safety issue: No ]
    Time in minutes from initiation of labor analgesia until delivery of the infant


Enrollment: 2162
Study Start Date: January 2006
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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:
  • combined spinal epidural analgesia
  • epidural labor analgesia
  • bupivacaine
  • fentanyl
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:
  • combined spinal epidural analgesia
  • epidural labor analgesia
  • bupivacaine
  • fentanyl

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Pregnant Women

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Outside specified time frame
  • Multiparity
  • Fetal demise
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00443560

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Cynthia A Wong, M.D. Northwestern University
  More Information

Publications:
Responsible Party: Cynthia Wong, Professor of Anesthesiology, Northwestern University
ClinicalTrials.gov Identifier: NCT00443560     History of Changes
Other Study ID Numbers: 0524-028
Study First Received: March 2, 2007
Results First Received: May 9, 2011
Last Updated: March 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Labor
Epidural Analgesia
delivery
vacuum extraction
obstetrical Forceps

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014