Spinal Analgesia Versus No Analgesia: Study for External Cephalic Version

• Status: Terminated
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hadassah Medical Organization
• Treatments: Anesthetics

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