Neuraxial vs. Systemic Analgesia for Latent Phase Labor Effect on Rate of Operative Delivery - Full Text View

Sponsors and Collaborators:	Northwestern University International Anesthesia Research Society (IARS)
Information provided by:	Northwestern University
ClinicalTrials.gov Identifier:	NCT00380978

Purpose

The purpose of this study in nulliparous women undergoing induction of labor is to determine whether initiation of neuraxial analgesia compared to systemic opioid analgesia early in labor (< 4 cm cervical dilation)affects the cesarean delivery rate.

Condition	Intervention
Pregnancy	Procedure: combined spinal epidural analgesia

MedlinePlus related topics: Cesarean Section

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Neuraxial vs. Systemic Analgesia for Latent Phase Labor Analgesia in Nulliparous Parturients With Induction of Labor: Effect on Rate of Operative Delivery

Further study details as provided by Northwestern University:

Primary Outcome Measures:

cesarean delivery rate [ Time Frame: Prospective: look forward using periodic observations collected predominantly following subject enrollment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

type of vaginal delivery [ Designated as safety issue: Yes ]
duration of labor [ Designated as safety issue: Yes ]
indication for cesarean delivery [ Designated as safety issue: Yes ]
analgesia efficacy
analgesia side effects [ Designated as safety issue: Yes ]
neonatal outcome [ Designated as safety issue: Yes ]

Estimated Enrollment:	1600
Study Start Date:	October 2001
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Detailed Description:

Women in early labor frequently request pain medication. Obstetricians may prescribe narcotics (administered as an intravenous (IV) or intramuscular (IM) shot). However, IV or IM narcotics provide incomplete pain relief and have maternal and fetal/neonatal side effects, e.g., maternal drowsiness, respiratory depression, nausea, and vomiting, and neonatal respiration depression. Other obstetricians allow their patients to request early neuraxial (spinal or epidural) analgesia. The results of several studies comparing patients who received epidural vs. IV/IM narcotic labor analgesia (not specifically early labor) suggest that initiation of early neuraxial analgesia may be associated with higher Cesarean delivery rates. It has been hypothesized that epidural/spinal local anesthetics may induce pelvic musculature relaxation leading to failure of fetal descent and rotation. However, early pain may be a marker for other factors that increase the risk of Cesarean delivery, e.g., large or malpositioned baby, or dysfunctional labor. Whether or not early neuraxial analgesia (particularly if narcotic based, which would not cause pelvic muscle paralysis) compared to IV/IM narcotics, adversely affects the outcome of labor has not been studied in a randomized, prospective fashion. The purpose of this study is to compare Cesarean and forceps delivery rates, and quality of pain relief, in first-time mothers undergoing induction of labor who receive neuraxial vs. IV/IM analgesia for early labor (cervical dilation < 4 cm).

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

induction of labor, nulliparity, > 36 weeks gestation, single gestation, vertex position, cervical dilation < 4 cm at first request for analgesia, desires neuraxial analgesia

Exclusion Criteria:

chronic opioid therapy, acute opioid therapy, allergy to study drugs (hydromorphone, fentanyl, bupivacaine, lidocaine)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00380978

Locations

United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

International Anesthesia Research Society (IARS)

Investigators

Principal Investigator:

Cynthia A Wong, MD

Northwestern University

More Information

Publications:

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.

Responsible Party:	Northwestern University ( Cynthia A. Wong M.D. )
Study ID Numbers:	0524-009
Study First Received:	September 25, 2006
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00380978
Health Authority:	United States: Institutional Review Board

Keywords provided by Northwestern University:

labor pain
cesarean section
epidural analgesia

opioid analgesics
local anesthetics
labor induced

Study placed in the following topic categories:

Labor Pain
Pain

ClinicalTrials.gov processed this record on February 11, 2009