The Association Between Decreasing Labor Analgesia Epidural Infusion and Forceps Delivery

NCT00443560 | Completed Results

• 1 other identifier: 0524-028
• Study Type: observational
• Target: 2,162
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain; Pregnancy

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (2)

• 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)

Study Arms (2)

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

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

Interventions

Case controlled analysis of epidural labor analgesia patterns OTHER

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

Also known as: combined spinal epidural analgesia, epidural labor analgesia, bupivacaine, fentanyl

Instrumental Vaginal Delivery (IVD); Spontaneous Vaginal Delivery (SVD)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant Women

You may qualify if:

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

You may not qualify if:

• Outside specified time frame
• Multiparity
• Fetal demise

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (11)

• Murphy DJ. Failure to progress in the second stage of labour. Curr Opin Obstet Gynecol. 2001 Dec;13(6):557-61. doi: 10.1097/00001703-200112000-00002.

  PMID: 11707657 BACKGROUND

• 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. doi: 10.1016/S0140-6736(00)05251-X.

  PMID: 11454372 BACKGROUND

• 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;2004(4):CD004457. doi: 10.1002/14651858.CD004457.pub2.

  PMID: 15495111 BACKGROUND

• 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. doi: 10.1097/00000539-200004000-00020.

  PMID: 10735793 BACKGROUND

• 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. doi: 10.1097/00000542-200002000-00019.

  PMID: 10691224 BACKGROUND

• Panni MK, Segal S. Local anesthetic requirements are greater in dystocia than in normal labor. Anesthesiology. 2003 Apr;98(4):957-63. doi: 10.1097/00000542-200304000-00024.

  PMID: 12657859 BACKGROUND

• 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. doi: 10.1016/s0029-7844(00)01230-8.

  PMID: 11275036 BACKGROUND

• 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. doi: 10.1056/NEJMoa042573.

  PMID: 15716559 BACKGROUND

• 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.

  BACKGROUND

• 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. doi: 10.1016/j.ajog.2007.06.051.

  PMID: 17826432 BACKGROUND

• Ziadeh S, Yahaya A. Pregnancy outcome at age 40 and older. Arch Gynecol Obstet. 2001 Mar;265(1):30-3. doi: 10.1007/s004040000122.

  PMID: 11327090 BACKGROUND

MeSH Terms

Conditions

Labor Pain

Interventions

Bupivacaine; Fentanyl

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The retrospective design incurs the risk of unrecorded or unobserved data. The sample selected included all patients with neuraxial analgesia who underwent IVD, but a limited sample of SVD.

Results Point of Contact

• Title: Dr. Robert J. McCarthy, PharmD
• Organization: Northwestern University Feinberg School of Medicine

r-mccarthy@northwestern.edu

312-926-9015

Study Officials

• Cynthia A Wong, M.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: March 2, 2007
• First Posted: March 6, 2007
• Study Start: January 1, 2006
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: April 14, 2014
• Results First Posted: July 21, 2011

Record last verified: 2014-03

Locations

US (1)