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Effect of Amnioinfusion on External Cephalic Version Successful Rate

Study acronym: AMNIO
StatusTerminated
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Enrollment target: estimated 240 to confirmed 119

    Publications: details revised at 1 of 42 entries

    Study Status, Sponsor/Collaborators, Study Design, Referencesv5

  2. Stopped

    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

    Study Status, Contacts/Locationsv4

  3. Minor

    Study Status

    Re-verified, no change to tracked fields

    v3

  4. Minor

    Primary completion date: Jul 2011

    Completion date: Jun 2008 to Jul 2011; Study arms: 0 to 2

    Study Identification, Study Status, Sponsor/Collaborators, Study Design, Arms and Interventions, Outcome Measuresv2

  5. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • 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 Breech Presentation
Enrollment 119 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov