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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assess the Risk-benefit Balance of the New Vacuum Assisted-delivery Device iCUP Versus the Reference Vacuum. Multicenter Prospective Randomized Controlled Study

Conditions
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Vacuum Extraction, Obstetrical, Randomized Controlled Trials, Failures, Medical Device, Maternal Lesions, Neonatal Lesions

Intervention / Treatment
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* Device: iCup
* Device: reference cup


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: vacuum extractor 'iCUP'<br>new vacuum extractor: sterile disposable plastic cup | Device: iCup<br>* new vacuum extractor: sterile disposable plastic cup<br>|
| Sham Comparator: reference vacuum extractor<br>reference cup of the obstetrical ward: metallic cup | Device: reference cup<br>* reference cup of the obstetrical ward: metallic cup<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |