The hypothesis is that the new vacuum assisted delivery device iCup is more effective than
the reference cup, in terms of maternal and newborn morbidities and functioning
Device: reference cup
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Full eligibility criteria for NCT01058200
Ages eligible for Study
18 Years to 45 Years
Genders eligible for Study
Accepts Healthy Volunteers
maternal age between 18 and 45 years old
singleton delivery after 37 weeks, in cephalic presentation,
indication of vacuum extraction,
affiliation to the french social security system or equivalent
no informed consent
singleton delivery before 37 weeks, in non-cephalic presentation,
patient deprived of freedom
All locations for NCT01058200
Besançon, France, 25000
Caen, France, 14000
Chambéry, France, 73000
Clermont Ferrand, France, 63000
Grenoble, France, 38000
Strasbourg, France, 67000
View full eligibility
Tris trial is registered with FDA with number: NCT01058200. The sponsor of the trial is University Hospital, Grenoble and it is looking for 668 volunteers for the current phase.
Official trial title: Assess the Risk-benefit Balance of the New Vacuum Assisted-delivery Device "iCUP" Versus the Reference Vacuum. Multicenter Prospective Randomized Controlled Study
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