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

Not Applicable

Completed

Conditions: Pregnancy
Labor Pain

Interventions: Procedure: combined spinal epidural analgesia
Procedure: late analgesia (systemic)

Registration Number: NCT00380978

Lead Sponsor: Northwestern University

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 1026

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
early analgesia:combined-spinal epidural	combined spinal epidural analgesia	-
late analgesia (systemic)	late analgesia (systemic)	-

Primary Outcome Measures

Name	Time	Method
Delivered by Cesarean Section	Time form initiation of labor analgesia to delivery (up to 24 hours)	The decision to proceed to operative delivery was made by the obstetric team for maternal or fetal indications.

Secondary Outcome Measures

Name	Time	Method
Instrumented Vaginal Delivery	At time of decision for delivery	The decision to proceed to assisted/instrumental delivery was made by the obstetric team for maternal or fetal indications.
Duration of Labor	Initiation of induction of labor to time of delivery	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	At time of decision for delivery	The decision to proceed to operative delivery was made by the obstetric team for maternal or fetal indications.
Analgesia Efficacy	At first and second analgesia requests	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	At second analgesia request	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)	APGAR score 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 at second analgesia request	Vomiting during labor analgesia