At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 668 enrolled
Drug / intervention
iCup +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Assess the Risk-benefit Balance of the New Vacuum Assisted-delivery Device "iCUP" Versus the Reference Vacuum. Multicenter Prospective Randomized Controlled Study
In Brief
A Phase 3 clinical trial evaluating iCup and reference cup for Vacuum Extraction, Obstetrical and 4 related conditions. Completed, enrolled 668 participants across 6 sites.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVacuum Extraction, Obstetrical, Randomized Controlled Trials, Failures, Medical Device, Maternal Lesions, Neonatal Lesions
CountriesFrance
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2009
First PostedJan 2010
Primary CompletionJun 2012
TodayJul 2026
First PostedJan 28, 2010
Enrollment StartOct 1, 2009
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 16.4 years ago
Interventions
iCupdevice
new vacuum extractor: sterile disposable plastic cup
reference cupdevice
reference cup of the obstetrical ward: metallic cup