Status:
TERMINATED
Spinal Analgesia Versus No Analgesia: Study for External Cephalic Version
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Breech Presentation
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
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; on...
Detailed Description
The rate of breech presentations in the general population of parturients has remained unchanged at 3%. However, the recent finding that the fetus has an increased morbidity during a vaginal delivery ...
Eligibility Criteria
Inclusion
- ASA I-II
- 37 + weeks gestation
- No previous attempt at ECV in this pregnancy
- No fetal abnormality
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00119184
Start Date
October 1 2002
End Date
May 1 2008
Last Update
November 28 2017
Active Locations (1)
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1
Hadassah Hebrew University Medical Center
Jerusalem, Israel, 12000