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Spinal Analgesia Versus No Analgesia: Study for External Cephalic Version

This study has been terminated.
( Multiparas study terminated due to poor recruitment. Randomization revealed only after decision recorded on clinicaltrials.gov )

Sponsored by: Hadassah Medical Organization
Information provided by: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00119184
  Purpose

The purpose of this study is to examine whether spinal anesthesia affects the chances of successful external cephalic version (ECV) of a breech presenting fetus.

Two study groups will be included; one will receive spinal anesthesia, the other will not. The non-spinal group will be permitted to cross over if ECV procedure is painful.

The main outcome is success of ECV.


Condition Intervention Phase
Breech Presentation
Procedure: External cephalic version with and without spinal anesthesia
Phase I

MedlinePlus related topics:   Anesthesia   

ChemIDplus related topics:   Bupivacaine    Bupivacaine hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title:   A Prospective Randomized Study to Examine the Success Rate of External Cephalic Version for Breech Presentation at Term Presentation: Spinal Analgesia Versus No Analgesia

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Conversion of a breech to a vertex presentation [ Time Frame: 4-6 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complications associated with ECV: Premature rupture of membranes, Contractions, Placental abruption, Fetal distress, Pain score during procedure (VAS Scale 0 = no pain, 10 = severe pain). [ Time Frame: 4-6 years ] [ Designated as safety issue: Yes ]
  • Complications associated with analgesia: Severe maternal hypotension (>20 reduction in systolic BP), Fetal distress (prior to performance of ECV), Post Dural Puncture Headache, Failure of analgesia. [ Time Frame: 4-6 years ] [ Designated as safety issue: Yes ]
  • Inability to perform procedure due to maternal distress or discomfort. [ Time Frame: 4-6 years ] [ Designated as safety issue: No ]
  • Mode of delivery and date from the ECV. [ Time Frame: 4-6 years ] [ Designated as safety issue: No ]

Estimated Enrollment:   140
Study Start Date:   October 2002
Study Completion Date:   May 2008
Primary Completion Date:   March 2006 (Final data collection date for primary outcome measure)

Intervention Details:
    Procedure: External cephalic version with and without spinal anesthesia
    7.5 mg bupivacaine intrathecally
Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • ASA I-II
  • 37 + weeks gestation
  • No previous attempt at ECV in this pregnancy
  • No fetal abnormality

Exclusion Criteria:

  • No previous uterine surgery
  • Any contraindication for vaginal delivery
  • Contra-indications to regional analgesia: uncorrected hypovolemia, coagulopathy (including anti-coagulants but not low-dose [100mg] aspirin), infection or inflammation of the skin overlying the lumbar area, raised intra-cranial pressure, hypersensitivity to amide local anesthetic agents.
  • Patient refusal for regional analgesia
  • Previous history of meningitis, neuropathy, or severe back pain with neurological radiation
  • Poor communication (no Hebrew or English spoken, deafness, blindness, serious intellectual impairment or psychiatric disorder)
  • Morbid obesity
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119184

Locations
Israel
Hadassah Hebrew University Medical Center    
      Jerusalem, Israel, 12000

Sponsors and Collaborators
Hadassah Medical Organization

Investigators
Principal Investigator:     Carolyn F Weiniger, MB ChB     Dept Anesthesiology, Hadassah Hebrew University Medical School    
  More Information

Publications indexed to this study:

Responsible Party:   Hadassah HMO ( Dr Carolyn Weiniger )
Study ID Numbers:   20-25/01/02-HMO-CTIL
First Received:   July 3, 2005
Last Updated:   June 5, 2008
ClinicalTrials.gov Identifier:   NCT00119184
Health Authority:   Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
anesthesia  
breech  
external cephalic version  
spinal
success
anesthesia,spinal

Study placed in the following topic categories:
Pregnancy Complications
Obstetric Labor Complications
Bupivacaine
Breech Presentation

ClinicalTrials.gov processed this record on August 20, 2008




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