TerminatedPhase 1

Spinal Analgesia Versus No Analgesia: Study for External Cephalic Version

Stopped: Multiparas study terminated due to poor recruitment. Randomization revealed only after decision recorded on clinicaltrials.gov

Israel140 participantsStarted 2002-10

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Conversion of a breech to a vertex presentation

Timeframe: 4-6 years

Trial details

NCT IDNCT00119184

SponsorHadassah Medical Organization

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2006-03

View on ClinicalTrials.gov More Breech Presentation trials