Clinical trial NCT00380978: 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
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Pregnancy
Keywords: labor pain
cesarean section
epidural analgesia
opioid analgesics
local anesthetics
labor induced
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: International Anesthesia Research Society (IARS)
First posted: 2006-09-27
Enrollment: 1026
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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)

Primary outcomes:
measure: Delivered by Cesarean Section
timeFrame: Time form initiation of labor analgesia to delivery (up to 24 hours)
Secondary outcomes:
measure: Instrumented Vaginal Delivery
timeFrame: At time of decision for delivery
measure: Duration of Labor
timeFrame: Initiation of induction of labor to time of delivery
measure: Indication for Cesarean Delivery
timeFrame: At time of decision for delivery
measure: Analgesia Efficacy
timeFrame: At first and second analgesia requests
measure: Nausea
timeFrame: At second analgesia request
measure: Neonatal Outcome (APGAR Score < 7 at 5 Minutes)
timeFrame: APGAR score at 5 minutes
measure: Vomiting
timeFrame: Vomiting at second analgesia request
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Cynthia A Wong, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.