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The Association Between Decreasing Labor Analgesia Epidural Infusion and Forceps Delivery
This study has been completed.
First Received: March 2, 2007   Last Updated: November 5, 2008   History of Changes
Sponsored by: Northwestern University
Information provided by: Northwestern University
ClinicalTrials.gov Identifier: NCT00443560
  Purpose

The objectives 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 confounders.

Hypothesis:

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


Condition Intervention
Labour
Analgesia, Epidural
Procedure: Chart Review

U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Retrospective
Official Title: The Association Between Decreasing Labor Analgesia Epidural Infusion and Forceps Delivery

Further study details as provided by Northwestern University:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 600
Study Start Date: January 2006
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Detailed Description:

The obstetrical anesthesia database will be queried for all forceps deliveries between the dates of January 2004 - January 2005. We anticipate that approximately 600 records of forceps delivery will be included. A matching cohort (equal number) of those having spontaneous vaginal deliveries will be examined. Subjects in the cohort group will be randomly chosen, matched for date of delivery and parity. The database will be queried for the following; maternal age, parity, gestational age, type of analgesia, changes in epidural infusion rate/ concentration, and supplemental bolus doses of local anesthesia. The data will be stripped of identification by the database manager Robert McCarthy (refer to attached letter) and entered into a secure 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. Variables will be compared using X2 and Mann-Whitney U test. A P< 0.05 will be required to reject the null hypothesis.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Pregnant Women

Criteria

Inclusion Criteria:

  • All forceps deliveries between the dates of January 2004 - January 2005.

Exclusion Criteria:

  • Not within the time frame
  Contacts and Locations
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

No publications provided

Responsible Party: Northwestern University ( Cynthia A. Wong M.D. )
Study ID Numbers: 0521-028
Study First Received: March 2, 2007
Last Updated: November 5, 2008
ClinicalTrials.gov Identifier: NCT00443560     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Labor
Forceps
Epidural Analgesia

ClinicalTrials.gov processed this record on May 07, 2009