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Neuraxial vs. Systemic Analgesia for Latent Phase Labor Effect on Rate of Operative Delivery

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Northwestern University
International Anesthesia Research Society
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

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

Secondary Outcome Measures:
  • type of vaginal delivery
  • duration of labor
  • indication for cesarean delivery
  • analgesia efficacy
  • analgesia side effects
  • neonatal outcome

Estimated Enrollment:   1600
Study Start Date:   October 2001

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

Investigators
Principal Investigator:     Cynthia A Wong, MD     Northwestern University    
  More Information


Publications:

Study ID Numbers:   0524-009
First Received:   September 25, 2006
Last Updated:   April 17, 2007
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 October 10, 2008




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