NCT00151346

Brief Summary

The purpose of this study to compare the use of spinal-epidural versus traditional labor epidural on maternal and fetal effects. The hope is to determine the safest and most effective epidural method of relieving pain during labor.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2003

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

March 18, 2008

Status Verified

March 1, 2008

Enrollment Period

2.9 years

First QC Date

September 6, 2005

Last Update Submit

March 17, 2008

Conditions

Labour Pain

Keywords

EpiduralLabour painPregnant womenEpidural anesthesiaLabour, Obstetriclabor painlabor, obstetriclabor analgesia

Outcome Measures

Primary Outcomes (1)

  • Adverse fetal effects: fetal bradycardia and abnormal fetal heart rate patterns

    during the 60 minutes after placement of analgesia

Secondary Outcomes (7)

  • Average change in systolic blood pressure

    during the 60 minutes after placement of analgesia

  • Average change in mean blood pressure

    during the 60 minutes after placement of analgesia

  • Blood pressure differences between the upper and lower extremities

    during the 60 minutes after placement of analgesia

  • Efficacy of analgesia as rated by the visual analog pain scale

    during the 60 minutes after analgesic placement

  • Pruritus

    through the first day following placement of analgesia

  • +2 more secondary outcomes

Study Arms (2)

CSE

ACTIVE COMPARATOR

Subjects assigned to this group will receive "combined spinal-epidural" (CSE) to relieve pain during labor. For CSE, subjects receive a small amount of a local anesthetic and a small amount of a narcotic pain killer directly into the spinal canal (a smaller amount than is given for traditional epidural), followed by a small amount of both of these medications that is continuously infused into the epidural space through a catheter that is left in place. CSE is not experimental.

Drug: Bupivacaine and Fentanyl (for CSE)

Traditional Epidural

ACTIVE COMPARATOR

Subjects assigned to this group will receive "traditional epidural" to relieve pain during labor. For the traditional epidural, subjects receive a small amount of a local anesthetic and a small amount of a narcotic pain killer into the epidural space, followed by a small amount of both of these medications that is continuously infused into the epidural space through a catheter that is left in place. The traditional epidural is not experimental.

Drug: Bupivacaine and Fentanyl (for traditional epidural)

Interventions

Bupivacaine and Fentanyl (for CSE)DRUG

Bupivacaine 0.25% x 1 cc + Fentanyl 20 mcg, followed by infusion of Bupivacaine 0.0625% with Fentanyl 2 mcg/mL at 12 cc/hr

Also known as: combined spinal-epidural, labor analgesia
CSE
Bupivacaine and Fentanyl (for traditional epidural)DRUG

Bupivacaine 0.0625% with Fentanyl 2 mcg/mL x 15 cc, followed by infusion of Bupivacaine 0.0625% with Fentanyl 2 mcg/mL at 12 cc/hr

Also known as: traditional epidural, labor analgesia
Traditional Epidural

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patient is able to read, understand and voluntarily sign the approved informed consent form (ICF) prior to any study- specific procedure;
  • Must be between 18 to 50 years of age.
  • Must be carrying a singleton fetus at term.
  • Must have less than a body mass index of 40.
  • Must be in labor, or is having a medical induction of labor.

You may not qualify if:

  • Patient who has chronic renal disease, pre-existing hypertension, or pre-eclampsia.
  • Patient who is undergoing an elective cesarean delivery
  • Patient who has a presence of non-reassuring fetal status
  • Patient who has an abnormal or non-reassuring fetal heart rate (FHR) pattern

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York-Presbyterian Hospital; Weill Medical College of Cornell

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Labor Pain

Interventions

BupivacaineFentanyl

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Daniel W. Skupski, M.D.

    Obstetrics & Gynecology; Weill Medical College of Cornell - New York Presbyterian Hospital

    PRINCIPAL INVESTIGATOR

  • Klaus Kjaer-Pedersen, M.D.

    Anesthesiology; Weill Medical College of Cornell - New York Presbyterian Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

October 1, 2003

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

March 18, 2008

Record last verified: 2008-03

Locations

US(1)