The Association Between Decreasing Labor Analgesia Epidural Infusion and Forceps Delivery

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00443560
• Collaborator: (none)
• Enrollment: 2,162
• Location: 1
• Duration (Months): 1.9
• Patients Per Site Per Month: 1115.4

Study Details

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	Phase
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: Jan 1, 2006
• Actual Primary Completion Date: Mar 1, 2006
• Actual Study Completion Date: Mar 1, 2006

Arms and Interventions

Arm	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 [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 [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 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

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• Murphy DJ. Failure to progress in the second stage of labour. Curr Opin Obstet Gynecol. 2001 Dec;13(6):557-61. Review.
• Panni MK, Segal S. Local anesthetic requirements are greater in dystocia than in normal labor. Anesthesiology. 2003 Apr;98(4):957-63.
• 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.
• 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.
• 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.
• 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: Mar 6, 2007
• Last Update Posted: Apr 14, 2014
• Last Verified: Mar 1, 2014

• Keywords provided by Cynthia Wong, Professor of Anesthesiology, Northwestern University: Labor; Epidural Analgesia; delivery; vacuum extraction; obstetrical Forceps
• Additional relevant MeSH terms: Labor Pain; Fentanyl; Bupivacaine

Study Results

Participant Flow

Recruitment Details	The Obstetric Anesthesiology Database was used to identify parturients from the Labor and Delivery Unit of Prentice Women's Hospital of Northwestern Memorial Hospital who qualified for the study between January 2004 and October 2005.

Arm/Group Title	Instrumental Vaginal Delivery (IVD)	Spontaneous Vaginal Delivery (SVD)
Arm/Group Description	Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.	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.
Period Title: Overall Study
STARTED	1081	1081
COMPLETED	1021	1051
NOT COMPLETED	60	30

Baseline Characteristics

Arm/Group Title	Instrumental Vaginal Delivery (IVD)	Spontaneous Vaginal Delivery (SVD)	Total
Arm/Group Description	Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.	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.	Total of all reporting groups
Overall Participants	1081	1081	2162
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	1081 100%	1081 100%	2162 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32 (3)	31 (3)	31 (3)
Sex: Female, Male (Count of Participants)
Female	1081 100%	1081 100%	2162 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	1081 100%	1081 100%	2162 100%

Outcome Measures

1. Primary Outcome

Title	Number of Parturients With a Decrease in the Infusion of Epidural Analgesia During Second Stage of Labor
Description	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.
Time Frame	Second stage of labor up to 3 hours

Outcome Measure Data

Analysis Population Description

Analysis was per protocal

Arm/Group Title	Instrumental Vaginal Delivery (IVD)	Spontaneous Vaginal Delivery (SVD)
Arm/Group Description	Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.	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.
Measure Participants	1021	1051
Number [participants]	146 13.5%	51 4.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Instrumental Vaginal Delivery (IVD), Spontaneous Vaginal Delivery (SVD)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	Chi-squared, Corrected
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.3
	Confidence Interval	() 95%; 2.3 to 4.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Number of Participants With Breakthrough Pain in the First Stage of Labor
Description	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.
Time Frame	Supplemental analgesia in first stage of labor (<24 hours)

Outcome Measure Data

Analysis Population Description

Analysis was per protocol

Arm/Group Title	Instrumental Vaginal Delivery (IVD)	Spontaneous Vaginal Delivery (SVD)
Arm/Group Description	Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.	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.
Measure Participants	1021	1051
Supplemental bolus	802 74.2%	243 22.5%
Infusion increase	149 13.8%	87 8%
Concentration increase	32 3%	19 1.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Instrumental Vaginal Delivery (IVD), Spontaneous Vaginal Delivery (SVD)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	Chi-squared, Corrected
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	12.2
	Confidence Interval	() 95%; 9.9 to 15.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Duration of Labor Analgesia
Description	Time in minutes from initiation of labor analgesia until delivery of the infant
Time Frame	Time form initiation of labor analgesia to delivery (up to 24 hours)

Outcome Measure Data

Analysis Population Description

Analysis was per protocal

Arm/Group Title	Instrumental Vaginal Delivery (IVD)	Spontaneous Vaginal Delivery (SVD)
Arm/Group Description	Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.	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.
Measure Participants	1021	1051
Median (Inter-Quartile Range) [minutes]	420	300

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Instrumental Vaginal Delivery (IVD), Spontaneous Vaginal Delivery (SVD)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Adverse Event Reporting Description	Adverse events were not extracted from charts reviewed in this study
Arm/Group Title	Instrumental Vaginal Delivery (IVD)		Spontaneous Vaginal Delivery (SVD)
Arm/Group Description	Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.		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.
All Cause Mortality
	Instrumental Vaginal Delivery (IVD)		Spontaneous Vaginal Delivery (SVD)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Instrumental Vaginal Delivery (IVD)		Spontaneous Vaginal Delivery (SVD)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Instrumental Vaginal Delivery (IVD)		Spontaneous Vaginal Delivery (SVD)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.