CompletedPhase 3

a Randomized Multicenter Trial Comparing Vacuum Assisted Delivery With the New Device "iCUP" Versus the Reference Cup.

France668 participantsStarted 2009-10

Plain-language summary

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

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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: * 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 Exclusion Criteria: * no informed consent * singleton delivery before 37 weeks, in non-cephalic presentation, * patient deprived of freedom

What they're measuring

Composite outcome: cup detachments (failure=3 detachments), other instrument used, caesarean section, caput succedaneum, cephalohaematoma, maternal perineal lesions. If one of these criteria at least is present, outcome is noted 'failure'; else 'success'

Timeframe: one day

Trial details

NCT IDNCT01058200

SponsorUniversity Hospital, Grenoble

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-06

View on ClinicalTrials.gov More Vacuum Extraction, Obstetrical trials