The Association Between Decreasing Labor Analgesia Epidural Infusion and Forceps Delivery

• ClinicalTrials.gov Identifier: NCT00443560
• Recruitment Status: Completed
• First Posted: March 6, 2007
• Results First Posted: July 21, 2011
• Last Update Posted: April 14, 2014
• Sponsor: Northwestern University
• Information provided by (Responsible Party): Cynthia Wong, Northwestern University

Study Description

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.

Condition or disease	Intervention/treatment
Labor Pain; Pregnancy	Other: Case controlled analysis of epidural labor analgesia patterns

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
• Actual Enrollment: 2162 participants
• 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
• Study Start Date: January 2006
• Actual Primary Completion Date: March 2006
• Actual Study Completion Date: March 2006

Groups and Cohorts

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: 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

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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.
2. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes 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

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:

Murphy DJ. Failure to progress in the second stage of labour. Curr Opin Obstet Gynecol. 2001 Dec;13(6):557-61. Review.

Comparative Obstetric Mobile Epidural Trial (COMET) Study Group UK. Effect of low-dose mobile versus traditional epidural techniques on mode of delivery: a randomised controlled trial. Lancet. 2001 Jul 7;358(9275):19-23.

Torvaldsen S, Roberts CL, Bell JC, Raynes-Greenow CH. Discontinuation of epidural analgesia late in labour for reducing the adverse delivery outcomes associated with epidural analgesia. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD004457. Review.

Hess PE, Pratt SD, Soni AK, Sarna MC, Oriol NE. An association between severe labor pain and cesarean delivery. Anesth Analg. 2000 Apr;90(4):881-6.

Cohen SE, Yeh JY, Riley ET, Vogel TM. Walking with labor epidural analgesia: the impact of bupivacaine concentration and a lidocaine-epinephrine test dose. Anesthesiology. 2000 Feb;92(2):387-92.

Panni MK, Segal S. Local anesthetic requirements are greater in dystocia than in normal labor. Anesthesiology. 2003 Apr;98(4):957-63.

Yancey MK, Zhang J, Schweitzer DL, Schwarz J, Klebanoff MA. Epidural analgesia and fetal head malposition at vaginal delivery. Obstet Gynecol. 2001 Apr;97(4):608-12.

Wong CA, Scavone BM, Peaceman AM, McCarthy RJ, Sullivan JT, Diaz NT, Yaghmour E, Marcus RJ, Sherwani SS, Sproviero MT, Yilmaz M, Patel R, Robles C, Grouper S. The risk of cesarean delivery with neuraxial analgesia given early versus late in labor. N Engl J Med. 2005 Feb 17;352(7):655-65.

9. Wong CA, Scavone BM, Sullivan JT, Ebarvia MJ, McCarthy RJ. The risk of cesarean delivery with early neuraxial analgesia in nulliparous induction of labor. http://www.asa-abstracts.com 2007:A1204.

Ben-Haroush A, Melamed N, Kaplan B, Yogev Y. Predictors of failed operative vaginal delivery: a single-center experience. Am J Obstet Gynecol. 2007 Sep;197(3):308.e1-5.

Ziadeh S, Yahaya A. Pregnancy outcome at age 40 and older. Arch Gynecol Obstet. 2001 Mar;265(1):30-3.

• Responsible Party: Cynthia Wong, Professor of Anesthesiology, Northwestern University
• ClinicalTrials.gov Identifier: NCT00443560
• Other Study ID Numbers: 0524-028
• First Posted: March 6, 2007
• Results First Posted: July 21, 2011
• Last Update Posted: April 14, 2014
• Last Verified: March 2014

Keywords provided by Cynthia Wong, Northwestern University:

Labor; Epidural Analgesia; delivery; vacuum extraction; obstetrical Forceps

Additional relevant MeSH terms:

Labor Pain; Pain; Neurologic Manifestations; Fentanyl; Bupivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Analgesics, Opioid; Narcotics; Analgesics; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General