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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01058200
Recruitment Status : Completed
First Posted : January 28, 2010
Last Update Posted : July 22, 2013
Information provided by (Responsible Party):
AdministrateurCIC, University Hospital, Grenoble

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

Condition or disease Intervention/treatment Phase
Vacuum Extraction, Obstetrical Randomized Controlled Trials Failures, Medical Device Maternal Lesions Neonatal Lesions Device: iCup Device: reference cup Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 668 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assess the Risk-benefit Balance of the New Vacuum Assisted-delivery Device "iCUP" Versus the Reference Vacuum. Multicenter Prospective Randomized Controlled Study
Study Start Date : October 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Arm Intervention/treatment
Active Comparator: vacuum extractor 'iCUP'
new vacuum extractor: sterile disposable plastic cup
Device: iCup
new vacuum extractor: sterile disposable plastic cup
Sham Comparator: reference vacuum extractor
reference cup of the obstetrical ward: metallic cup
Device: reference cup
reference cup of the obstetrical ward: metallic cup

Primary Outcome Measures :
  1. 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' [ Time Frame: one day ]

Secondary Outcome Measures :
  1. maternal lesions: cervix lesions, postpartum haemorrhage [ Time Frame: 28 days maximum ]
  2. neonatal lesions: minor scalp injuries, Apgar score < 7, pH < 7.20, anaemia, jaundice, transfer [ Time Frame: 28 days maximum ]
  3. medico-economic criteria: cost-effectiveness analysis of the studied medical devices [ Time Frame: 28 days maximum ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01058200

University Hospital
Besançon, France, 25000
University Hospital
Caen, France, 14000
Chambéry, France, 73000
University Hospital
Clermont Ferrand, France, 63000
University Hospital
Grenoble, France, 38000
University Hospital
Strasbourg, France, 67000
Sponsors and Collaborators
University Hospital, Grenoble
Principal Investigator: Jean-Patrick SCHAAL, MD PHD University Hospital, Grenoble

Schaal JP, Riethmuller D, Menget A. Extractions instrumentales du fœtus : ventouse obstétricale. Encycl Méd Chir Paris: Elsevier, 2004 (vol Obstétrique)

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AdministrateurCIC, Dr Véronique EQUY, University Hospital, Grenoble., University Hospital, Grenoble Identifier: NCT01058200     History of Changes
Other Study ID Numbers: DCIC 07 23
First Posted: January 28, 2010    Key Record Dates
Last Update Posted: July 22, 2013
Last Verified: July 2013