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 range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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