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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)
Sponsor:
Hadassah Medical Organization
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00119184
First received: July 3, 2005
Last updated: June 5, 2008
Last verified: May 2008
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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 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
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00119184
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr Carolyn Weiniger, Hadassah HMO |
| ClinicalTrials.gov 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:
|
anesthesia breech external cephalic version |
spinal success anesthesia,spinal |
Additional relevant MeSH terms:
|
Breech Presentation Obstetric Labor Complications Pregnancy Complications |
Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 21, 2017