Failures, Medical Device, Maternal Lesions, Neonatal Lesions, Randomized Controlled Trials, Vacuum Extraction, Obstetrical
Conditions
Brief 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
Detailed description
Currently, instrumental extractions are used in about 10% to 15% of the 860 000 annual deliveries in France and the use of vacuum extractors increases from year to year. In addition to sterilizable vacuum extractors several different types of vacuum extractor have been developed, in particular the single use Kiwi cup or the so-called 'soft' cup extractors. However, studies evaluating these new cups have not shown their superiority in comparison to the conventional metallic vacuum extractor. Accordingly, it is legitimate to assess the new vacuum extractor iCup, an innovative mix of metallic cup and 'soft' cups that should combine the advantages of both; and to compare the iCup vacuum extractor with the sterilizable metallic cup extractor, the most effective vacuum extractors available to date.
Interventions
DEVICEiCup
new vacuum extractor: sterile disposable plastic cup
DEVICEreference cup
reference cup of the obstetrical ward: metallic cup
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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' | one day |
Secondary
| Measure | Time frame |
|---|---|
| maternal lesions: cervix lesions, postpartum haemorrhage | 28 days maximum |
| neonatal lesions: minor scalp injuries, Apgar score < 7, pH < 7.20, anaemia, jaundice, transfer | 28 days maximum |
| medico-economic criteria: cost-effectiveness analysis of the studied medical devices | 28 days maximum |
Countries
France
Outcome results
None listed