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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
Information provided by:
Hadassah Medical Organization Identifier:
First received: July 3, 2005
Last updated: June 5, 2008
Last verified: May 2008

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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:

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 ]

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 ]
  • 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 ]
  • Inability to perform procedure due to maternal distress or discomfort. [ Time Frame: 4-6 years ]
  • Mode of delivery and date from the ECV. [ Time Frame: 4-6 years ]

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


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00119184

Hadassah Hebrew University Medical Center
Jerusalem, Israel, 12000
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Carolyn F Weiniger, MB ChB Dept Anesthesiology, Hadassah Hebrew University Medical School
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr Carolyn Weiniger, Hadassah HMO Identifier: NCT00119184     History of Changes
Other Study ID Numbers: 20-25/01/02-HMO-CTIL
Study First Received: July 3, 2005
Last Updated: June 5, 2008

Keywords provided by Hadassah Medical Organization:
external cephalic version

Additional relevant MeSH terms:
Breech Presentation
Obstetric Labor Complications
Pregnancy Complications
Central Nervous System Depressants
Physiological Effects of Drugs processed this record on September 21, 2017