Trial Outcomes & Findings for Neuraxial Versus Systemic Analgesia for Latent Phase Labor Effect on Rate of Operative Delivery (NCT NCT00380978)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1026 participants

Primary outcome timeframe

Time form initiation of labor analgesia to delivery (up to 24 hours)

Results posted on

2014-04-14

Participant Flow

Between October 2001 and December 2006, women presenting at Prentice Women's Hospital for induction of labor and who desired neuraxial analgesia were eligible to participate. Patients were asked to participate by study personnel after admission to the Labor and Delivery Unit and gave written informed consent before request for analgesia.

A total of 1,026 women consented to participate. 208 women were excluded because cervical dilation was 4 cm or more at the first analgesia request. Twelve participants were excluded after randomization because they did not receive the allocated intervention and outcome data were not available. The remaining 806 women were included in the analysis.

Participant milestones

Participant milestones
Measure	Early Analgesia:Combined-spinal Epidural Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.	Systemic Analgesia Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
Overall Study STARTED	408	410
Overall Study COMPLETED	406	400
Overall Study NOT COMPLETED	2	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Early Analgesia:Combined-spinal Epidural Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.	Systemic Analgesia Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
Overall Study Refused allocated intervention	0	6
Overall Study Wrong study envelope	0	2
Overall Study Allocation prior to analgesia request	1	2
Overall Study Parous patient	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Early Analgesia:Combined-spinal Epidural n=408 Participants Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.	Systemic Analgesia n=410 Participants Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural	Total n=818 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	408 Participants n=5 Participants	410 Participants n=7 Participants	818 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	31 years STANDARD_DEVIATION 6 • n=5 Participants	31 years STANDARD_DEVIATION 5 • n=7 Participants	31 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	408 Participants n=5 Participants	410 Participants n=7 Participants	818 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	408 participants n=5 Participants	410 participants n=7 Participants	818 participants n=5 Participants

PRIMARY outcome

Timeframe: Time form initiation of labor analgesia to delivery (up to 24 hours)

Population: Analysis per protocol. 10 did not receive intervention in combined spinal epidural group and 2 in the systemic analgesia group

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

Outcome measures

Outcome measures
Measure	Early Analgesia:Combined-spinal Epidural n=406 Participants Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.	Systemic Analgesia n=400 Participants Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
Delivered by Cesarean Section	134 participants	126 participants

SECONDARY outcome

Timeframe: At time of decision for delivery

Population: Per protocol - subjects that delivered vaginally

The decision to proceed to assisted/instrumental delivery was made by the obstetric team for maternal or fetal indications.

Outcome measures

Outcome measures
Measure	Early Analgesia:Combined-spinal Epidural n=272 Participants Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.	Systemic Analgesia n=274 Participants Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
Instrumented Vaginal Delivery	57 participants	59 participants

SECONDARY outcome

Timeframe: Initiation of induction of labor to time of delivery

Population: Per protocol

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.

Outcome measures

Outcome measures
Measure	Early Analgesia:Combined-spinal Epidural n=406 Participants Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.	Systemic Analgesia n=400 Participants Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
Duration of Labor	528 minutes Interval 491.0 to 564.0	569 minutes Interval 538.0 to 600.0

SECONDARY outcome

Timeframe: At time of decision for delivery

Population: Number of cesarean deliveries

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

Outcome measures

Outcome measures
Measure	Early Analgesia:Combined-spinal Epidural n=134 Participants Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.	Systemic Analgesia n=126 Participants Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
Indication for Cesarean Delivery Arrested dilation	85 participants	83 participants
Indication for Cesarean Delivery Arrested descent	18 participants	23 participants
Indication for Cesarean Delivery Non-reassuring fetal status	27 participants	16 participants
Indication for Cesarean Delivery Other	4 participants	4 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Early Analgesia:Combined-spinal Epidural n=406 Participants Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.	Systemic Analgesia n=400 Participants Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
Analgesia Efficacy	1 Scores on a scale Interval 0.0 to 3.0	5 Scores on a scale Interval 3.0 to 6.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Early Analgesia:Combined-spinal Epidural n=406 Participants Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.	Systemic Analgesia n=400 Participants Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
Nausea None	372 participants	265 participants
Nausea Mild	25 participants	69 participants
Nausea Moderate	5 participants	49 participants
Nausea Severe	2 participants	16 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Early Analgesia:Combined-spinal Epidural n=406 Participants Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.	Systemic Analgesia n=400 Participants Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
Neonatal Outcome (APGAR Score < 7 at 5 Minutes)	14 participants	6 participants

SECONDARY outcome

Timeframe: Vomiting at second analgesia request

Vomiting during labor analgesia

Outcome measures

Outcome measures
Measure	Early Analgesia:Combined-spinal Epidural n=406 Participants Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.	Systemic Analgesia n=400 Participants Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
Vomiting	12 participants	61 participants

Adverse Events

Early Analgesia:Combined-spinal Epidural

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Systemic Analgesia

Serious events: 0 serious events

Other events: 134 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Early Analgesia:Combined-spinal Epidural n=406 participants at risk Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.	Systemic Analgesia n=400 participants at risk Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
Gastrointestinal disorders Nausea and/or vomiting	7.9% 32/406 • Number of events 32	33.5% 134/400 • Number of events 134

Additional Information

Dr. Robert J. McCarthy

Department of Anesthesiology; Northwestern University Feinberg School of Medicine

Phone: 312-926-9015

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place