NCT01058200

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 668 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	iCup	new vacuum extractor: sterile disposable plastic cup
DEVICE	reference cup	reference cup of the obstetrical ward: metallic cup

Timeline

• Start date: 2009-10-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2010-01-28
• Last updated: 2013-07-22

Locations

6 sites across 1 country: France