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

This study has been completed.

Study NCT00380978 Information provided by Northwestern University

First Received on September 25, 2006. Last Updated on November 6, 2011 History of Changes

Results First Received: July 5, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Labor Pain Pregnancy
Interventions:	Procedure: combined spinal epidural analgesia Procedure: late analgesia (systemic)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
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

Participant Flow: Overall Study

	Early Analgesia:Combined-spinal Epidural	Systemic Analgesia
STARTED	408	410
COMPLETED	406	400
NOT COMPLETED	2	10
Refused allocated intervention	0	6
Wrong study envelope	0	2
Allocation prior to analgesia request	1	2
Parous patient	1	0

Baseline Characteristics

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Reporting Groups

	Description
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

Baseline Measures

	Early Analgesia:Combined-spinal Epidural	Systemic Analgesia	Total
Number of Participants [units: participants]	408	410	818
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	408	410	818
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	31 ± 6	31 ± 5	31 ± 6
Gender [units: participants]
Female	408	410	818
Male	0	0	0
Region of Enrollment [units: participants]
United States	408	410	818

Outcome Measures

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1. Primary:

Delivered by Cesarean Section [ Time Frame: Time form initiation of labor analgesia to delivery (up to 24 hours) ]

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2. Secondary:

Instrumented Vaginal Delivery [ Time Frame: At time of decision for delivery ]

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3. Secondary:

Duration of Labor [ Time Frame: Initiation of induction of labor to time of delivery ]

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4. Secondary:

Indication for Cesarean Delivery [ Time Frame: At time of decision for delivery ]

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5. Secondary:

Analgesia Efficacy [ Time Frame: At first and second analgesia requests ]

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6. Secondary:

Nausea [ Time Frame: At second analgesia request ]

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7. Secondary:

Neonatal Outcome (APGAR Score < 7 at 5 Minutes) [ Time Frame: APGAR score at 5 minutes ]

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8. Secondary:

Vomiting [ Time Frame: Vomiting at second analgesia request ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was not powered to detect a small difference between groups in the cesarean delivery rate. It was not blinded. Different obstetric providers have different management styles, and different triggers for performing cesarean delivery.

Results Point of Contact:

Name/Title: Dr. Robert J. McCarthy
Organization: Department of Anesthesiology; Northwestern University Feinberg School of Medicine
phone: 312-926-9015
e-mail: r-mccarthy@northwestern.edu

Publications:

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.

Responsible Party:	Cynthia Wong, 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