Spinal Analgesia Versus No Analgesia: Study for External Cephalic Version
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| ClinicalTrials.gov Identifier: NCT00119184 |
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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
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Sponsor:
Hadassah Medical Organization
Information provided by:
Hadassah Medical Organization
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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 |
Show Detailed Description
| 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 |
|---|---|
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Experimental: External cephalic version with spinal anesthesia
External cephalic version with spinal anesthesia
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Procedure: External cephalic version
7.5 mg bupivacaine intrathecally Drug: spinal anesthesia spinal anesthesia |
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Active Comparator: External cephalic version without spinal anesthesia
External cephalic version without spinal anesthesia
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Procedure: External cephalic version
7.5 mg bupivacaine intrathecally |
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 ]
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| 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
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
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 |
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 |
| First Posted: | July 13, 2005 Key Record Dates |
| Last Update Posted: | November 28, 2017 |
| Last Verified: | May 2008 |
Keywords provided by Hadassah Medical Organization:
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anesthesia breech external cephalic version |
spinal success anesthesia,spinal |
Additional relevant MeSH terms:
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Breech Presentation Obstetric Labor Complications Pregnancy Complications |
Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |