search
Back to results

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

Primary Purpose

Labor Pain, Pregnancy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
combined spinal epidural analgesia
late analgesia (systemic)
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring labor pain, cesarean section, epidural analgesia, opioid analgesics, local anesthetics, labor induced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Northwestern Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

early analgesia:combined-spinal epidural

late analgesia (systemic)

Arm Description

Outcomes

Primary Outcome Measures

Delivered by Cesarean Section
The decision to proceed to operative delivery was made by the obstetric team for maternal or fetal indications.

Secondary Outcome Measures

Instrumented Vaginal Delivery
The decision to proceed to assisted/instrumental delivery was made by the obstetric team for maternal or fetal indications.
Duration of Labor
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
The decision to proceed to operative delivery was made by the obstetric team for maternal or fetal indications.
Analgesia Efficacy
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
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)
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
Vomiting during labor analgesia

Full Information

First Posted
September 25, 2006
Last Updated
March 17, 2014
Sponsor
Northwestern University
Collaborators
International Anesthesia Research Society (IARS)
search

1. Study Identification

Unique Protocol Identification Number
NCT00380978
Brief Title
Neuraxial Versus Systemic Analgesia for Latent Phase Labor Effect on Rate of Operative Delivery
Official Title
Early Compared With Late Neuraxial Analgesia in Nulliparous Labor Induction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
International Anesthesia Research Society (IARS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain, Pregnancy
Keywords
labor pain, cesarean section, epidural analgesia, opioid analgesics, local anesthetics, labor induced

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1026 (Actual)

8. Arms, Groups, and Interventions

Arm Title
early analgesia:combined-spinal epidural
Arm Type
Active Comparator
Arm Title
late analgesia (systemic)
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
combined spinal epidural analgesia
Other Intervention Name(s)
CSE
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
late analgesia (systemic)
Other Intervention Name(s)
Dilaudid, narcotic
Intervention Description
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.
Primary Outcome Measure Information:
Title
Delivered by Cesarean Section
Description
The decision to proceed to operative delivery was made by the obstetric team for maternal or fetal indications.
Time Frame
Time form initiation of labor analgesia to delivery (up to 24 hours)
Secondary Outcome Measure Information:
Title
Instrumented Vaginal Delivery
Description
The decision to proceed to assisted/instrumental delivery was made by the obstetric team for maternal or fetal indications.
Time Frame
At time of decision for delivery
Title
Duration of Labor
Description
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.
Time Frame
Initiation of induction of labor to time of delivery
Title
Indication for Cesarean Delivery
Description
The decision to proceed to operative delivery was made by the obstetric team for maternal or fetal indications.
Time Frame
At time of decision for delivery
Title
Analgesia Efficacy
Description
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.
Time Frame
At first and second analgesia requests
Title
Nausea
Description
Participants were asked to rate their nausea (as none, mild, moderate, or severe) and report the presence or absence of vomiting.
Time Frame
At second analgesia request
Title
Neonatal Outcome (APGAR Score < 7 at 5 Minutes)
Description
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.
Time Frame
APGAR score at 5 minutes
Title
Vomiting
Description
Vomiting during labor analgesia
Time Frame
Vomiting at second analgesia request

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia A Wong, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15716559
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs