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

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Completed; Phase 3

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

Treatments: Device: reference cup; Device: iCup

Study type: Interventional

Funder types: Other

Identifiers

NCT01058200

DCIC 07 23

Details and patient eligibility

About

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

Full 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.

Enrollment: 668 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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668 participants in 2 patient groups

vacuum extractor 'iCUP'

Active Comparator group

Description:

new vacuum extractor: sterile disposable plastic cup

Treatment:

Device: iCup

reference vacuum extractor

Sham Comparator group

Description:

reference cup of the obstetrical ward: metallic cup

Treatment:

Device: reference cup