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Spinal Analgesia Versus No Analgesia: Study for External Cephalic Version

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ClinicalTrials.gov Identifier: NCT00119184
Recruitment Status : Terminated (Multiparas study terminated due to poor recruitment. Randomization revealed only after decision recorded on clinicaltrials.gov)
First Posted : July 13, 2005
Last Update Posted : November 28, 2017
Information provided by:
Hadassah Medical Organization

Brief Summary:

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 or disease Intervention/treatment Phase
Breech Presentation Procedure: External cephalic version Drug: spinal anesthesia Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
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
Study Start Date : October 2002
Actual Primary Completion Date : March 2006
Actual Study Completion Date : May 2008

Arm Intervention/treatment
Experimental: External cephalic version with spinal anesthesia
External cephalic version with spinal anesthesia
Procedure: External cephalic version
7.5 mg bupivacaine intrathecally

Drug: spinal anesthesia
spinal anesthesia

Active Comparator: External cephalic version without spinal anesthesia
External cephalic version without spinal anesthesia
Procedure: External cephalic version
7.5 mg bupivacaine intrathecally

Primary Outcome Measures :
  1. Conversion of a breech to a vertex presentation [ Time Frame: 4-6 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Inability to perform procedure due to maternal distress or discomfort. [ Time Frame: 4-6 years ]
  4. Mode of delivery and date from the ECV. [ Time Frame: 4-6 years ]

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00119184

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Hadassah Hebrew University Medical Center
Jerusalem, Israel, 12000
Sponsors and Collaborators
Hadassah Medical Organization
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Principal Investigator: Carolyn F Weiniger, MB ChB Dept Anesthesiology, Hadassah Hebrew University Medical School
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Carolyn Weiniger, Hadassah HMO
ClinicalTrials.gov Identifier: NCT00119184    
Other Study ID Numbers: 20-25/01/02-HMO-CTIL
First Posted: July 13, 2005    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: May 2008
Keywords provided by Hadassah Medical Organization:
external cephalic version
Additional relevant MeSH terms:
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Breech Presentation
Obstetric Labor Complications
Pregnancy Complications
Central Nervous System Depressants
Physiological Effects of Drugs