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Neuraxial Versus Systemic Analgesia for Latent Phase Labor Effect on Rate of Operative Delivery
This study has been completed.

First Received on September 25, 2006.   Last Updated on November 6, 2011   History of Changes
Sponsor: Northwestern University
Collaborator: International Anesthesia Research Society (IARS)
Information provided by (Responsible Party): Cynthia Wong, 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
Labor Pain
Pregnancy
Procedure: combined spinal epidural analgesia
Procedure: late analgesia (systemic)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Compared With Late Neuraxial Analgesia in Nulliparous Labor Induction

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Delivered by Cesarean Section [ Time Frame: Time form initiation of labor analgesia to delivery (up to 24 hours) ] [ Designated as safety issue: No ]
    The decision to proceed to operative delivery was made by the obstetric team for maternal or fetal indications.


Secondary Outcome Measures:
  • Instrumented Vaginal Delivery [ Time Frame: At time of decision for delivery ] [ Designated as safety issue: No ]
    The decision to proceed to assisted/instrumental delivery was made by the obstetric team for maternal or fetal indications.

  • Duration of Labor [ Time Frame: Initiation of induction of labor to time of delivery ] [ Designated as safety issue: No ]
    Labor was induced by initiating an oxytocin infusion or by infusing extra-amniotic saline followed by oxytocin. All participants had continuous external electronic fetal heart rate (FHR) monitoring and tocodynamometry. Internal fetal scalp electrodes were placed when the external tracing was not interpretable, and intrauterine pressure catheters were used to measure the intensity of contractions when deemed necessary by the obstetricians. Artificial rupture of membranes was performed, and nurses titrated oxytocin infusions according to institutional protocol.

  • Indication for Cesarean Delivery [ Time Frame: At time of decision for delivery ] [ Designated as safety issue: No ]
    The decision to proceed to operative delivery was made by the obstetric team for maternal or fetal indications.

  • Analgesia Efficacy [ Time Frame: At first and second analgesia requests ] [ Designated as safety issue: No ]
    Patients were asked to rate their average pain score using an 11-point verbal rating score (VRS)for pain (0 - 10: 0= no pain, 10= worst pain imaginable) between 1st and 2nd analgesia request.

  • Nausea [ Time Frame: At second analgesia request ] [ Designated as safety issue: No ]
    Participants were asked to rate their nausea (as none, mild, moderate, or severe) and report the presence or absence of vomiting.

  • Neonatal Outcome (APGAR Score < 7 at 5 Minutes) [ Time Frame: APGAR score at 5 minutes ] [ Designated as safety issue: No ]
    Infant's Apgar scores measured at 5 minutes of life and were assigned by nurses and pediatricians responsible for neonatal assessment. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing the five values. The categories are skin color, pulse, reflex to stimulation, muscle tome, and breathing. The test was done at one and five minutes after birth, and may be repeated later if the score is and remains low. Scores 3 and below are generally regarded as critically low, 4 to 6 fairly low, and 7 to 10 generally normal.

  • Vomiting [ Time Frame: Vomiting at second analgesia request ] [ Designated as safety issue: No ]
    Vomiting during labor analgesia


Enrollment: 1026
Study Start Date: October 2001
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: early analgesia:combined-spinal epidural Procedure: combined spinal epidural analgesia
Analgesia was initiated in the early group using a standard needle-through-needle technique with intrathecal fentanyl 25 mcg and an epidural test dose of lidocaine 15 mg/ml and epinephrine 5 mcg/ml in 3ml. At the second analgesia request, the cervix was examined. Epidural analgesia was initiated with a dilute bupivicaine/fentanyl solution if the cervix was less than 4 cm. If the cervix was 4 cm or more, epidural analgesia was initiated with bupivicaine 1.25 mg/ml. If no cervical exam was performed at the second request for analgesia, the cervix was assumed to be at least 4 cm dilated. Thereafter, analgesia was maintained in all participants in the early group with patient-controlled epidural analgesia.
Other Name: CSE
Active Comparator: late analgesia (systemic) Procedure: late analgesia (systemic)
Analgesia was initiated in the late group with hydromorphone 1mg intramuscularly (IM) and 1 mg intravenously (IV). If the cervix was less than 4 cm at the second analgesia request, hydromorphone analgesia was repeated. Epidural analgesia was initiated with bupivicaine 1.25 mg/ml if the cervix was 4 cm or more. At the third analgesia request, epidural analgesia was initiated regardless of cervical dilation. Thereafter, epidural analgesia was maintained with patient controlled analgesia until delivery.
Other Name: Dilaudid, narcotic

Detailed Description:

Women in early labor frequently request pain medication. Obstetricians may prescribe narcotics (administered as an intravenous (IV) or intramuscular (IM) injection). However, IV or IM narcotics provide incomplete pain relief and have maternal and fetal/neonatal side effects, e.g., maternal drowsiness, respiratory depression, nausea, vomiting, and neonatal respiratory depression. Other obstetricians allow their patients to request early neuraxial (spinal or epidural) analgesia. The results of several studies comparing patients who received epidural versus IV/IM narcotic labor analgesia (not specifically in 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 forcep delivery rates, and quality of pain relief, in first-time mothers undergoing induction of labor who receive neuraxial versus IV/IM analgesia for early labor (cervical dilation < 4 cm).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • spontaneously laboring
  • multiparity
  • nonvertex presentation
  • at or >4cm at analgesia request
  • chronic opioid therapy
  • acute opioid therapy within 4 hours of analgesia request
  • 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:
Responsible Party: Cynthia Wong, Professor of Anesthesiology, Northwestern University
ClinicalTrials.gov Identifier: NCT00380978     History of Changes
Other Study ID Numbers: 0524-009
Study First Received: September 25, 2006
Results First Received: July 5, 2011
Last Updated: November 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
labor pain
cesarean section
epidural analgesia
opioid analgesics
local anesthetics
labor induced

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on February 12, 2012