NCT00565383

Brief Summary

We aim to answer the clinical question: Does combined spinal-epidural analgesia improve the success rate of external cephalic version? We hypothesize that neuraxial analgesia (spinal or epidural analgesia) during version for breech presentation increases successful fetal rotation and decreases the incidence of Cesarean delivery for malpresentation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Aug 2002

Longer than P75 for not_applicable pregnancy

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 30, 2007

Completed
Last Updated

June 13, 2013

Status Verified

June 1, 2013

Enrollment Period

3.8 years

First QC Date

November 29, 2007

Last Update Submit

June 12, 2013

Conditions

PregnancyBreech Presentation

Keywords

Pregnancy37 Weeks GestationBreech PresentationVersion ProcedurePain ControlNeuraxial analgesia

Outcome Measures

Primary Outcomes (1)

  • Does combined spinal-epidural analgesia improve the success rate of external cephalic version?

    Time between analgesia intervention for the version procedure and delivery

Secondary Outcomes (3)

  • Mode of delivery

    At delivery

  • Maternal satisfaction

    Between analgesic intervention and the completion of the version procedure

  • Maternal Pain

    Between analgesic intervention and termination of the version procedure

Study Arms (2)

Intravenous fentanyl analgesia

ACTIVE COMPARATOR

Intravenous fentanyl (50 mcg) analgesia

Procedure: Intravenous fentanyl (50mcg)

Combined spinal-epidural analgesia

EXPERIMENTAL

Combined spinal-epidural analgesia (intrathecal fentanyl 2.5 mg plus bupivacaine 2.5 mg) single administration

Procedure: Combined spinal-epidural analgesia

Interventions

Combined spinal-epidural analgesiaPROCEDURE

Combined spinal-epidural

Combined spinal-epidural analgesia
Intravenous fentanyl (50mcg)PROCEDURE

Intravenous fentanyl

Intravenous fentanyl analgesia

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • Female
  • Pregnant
  • Breech Presentation
  • Greater than 36 Weeks gestation
  • Version Procedure

You may not qualify if:

  • Under 18 or over 55 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prentice Women's Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (4)

  • Fortunato SJ, Mercer LJ, Guzick DS. External cephalic version with tocolysis: factors associated with success. Obstet Gynecol. 1988 Jul;72(1):59-62.

    PMID: 3288930BACKGROUND

  • Zhang J, Bowes WA Jr, Fortney JA. Efficacy of external cephalic version: a review. Obstet Gynecol. 1993 Aug;82(2):306-12.

    PMID: 8336883BACKGROUND

  • Carlan SJ, Dent JM, Huckaby T, Whittington EC, Shaefer D. The effect of epidural anesthesia on safety and success of external cephalic version at term. Anesth Analg. 1994 Sep;79(3):525-8. doi: 10.1213/00000539-199409000-00021.

    PMID: 8067558BACKGROUND

  • Birnbach DJ, Matut J, Stein DJ, Campagnuolo J, Drimbarean C, Grunebaum A, Kuroda MM, Thys DM. The effect of intrathecal analgesia on the success of external cephalic version. Anesth Analg. 2001 Aug;93(2):410-3, 4th contents page. doi: 10.1097/00000539-200108000-00035.

    PMID: 11473871BACKGROUND

MeSH Terms

Conditions

Breech PresentationAgnosia

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • John T Sullivan, M.D.

    Northwestern University Feinberg School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
John T. Sullivan M.D.

Study Record Dates

First Submitted

November 29, 2007

First Posted

November 30, 2007

Study Start

August 1, 2002

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

June 13, 2013

Record last verified: 2013-06

Locations

US(1)