Effect of Amnioinfusion on External Cephalic Version Successful Rate

Study acronym: AMNIO
StatusTerminated
PhaseNot applicable
Started

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Record History

  1. Enrollment target: estimated 240 to confirmed 119
    • Publications: details revised at 1 of 42 entries
    v5
  2. Trial status: Recruiting to Terminated
    • Primary and study completion dates changed from estimate of Jul 2011 to May 2011
    • Site details revised at 2 of 2 sites
    v4
  3. Re-verified, no change to tracked fieldsv3
  4. Primary completion date: Jul 2011
    • Study completion date: Jun 2008 to Jul 2011
    • Study arms: 0 to 2
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The aim of the study is to evaluate the effect of transabdominal amnioinfusion before second external cephalic version after initial failure.Patient with a single foetus, at term, in breech presentation and after a first cephalic version are included. The randomisation determines whether the patient is included in the group with amnioinfusion before second cephalic version or with usual second cephalic version only; The efficacy's evaluation is based on rate of cephalic presentation at birth.Success rate of cephalic version with or without transabdominal amnioinfusion, rates of cesarian section in the two groups,maternal and fetal morbidity, time between second cephalic version and birth will be studied. Prospective interventional randomized sequential comparative multicentric study. A maximum of 240 patients will be included (120 in each group). As the study is sequential it will be over as soon as a significative difference is shown.
Trial Details
NCT Number NCT00465712
Lead Sponsor University Hospital, Tours
Conditions
(from sponsor)		 Breech Presentation
Related terms Breech Presentation
Enrollment 119 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov