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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AdministrateurCIC, University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01058200
First received: January 27, 2010
Last updated: July 19, 2013
Last verified: July 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • maternal lesions: cervix lesions, postpartum haemorrhage [ Time Frame: 28 days maximum ] [ Designated as safety issue: Yes ]
  • neonatal lesions: minor scalp injuries, Apgar score < 7, pH < 7.20, anaemia, jaundice, transfer [ Time Frame: 28 days maximum ] [ Designated as safety issue: Yes ]
  • medico-economic criteria: cost-effectiveness analysis of the studied medical devices [ Time Frame: 28 days maximum ] [ Designated as safety issue: No ]

Enrollment: 668
Study Start Date: October 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01058200

Locations
France
University Hospital
Besançon, France, 25000
University Hospital
Caen, France, 14000
Hospital
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
Investigators
Principal Investigator: Jean-Patrick SCHAAL, MD PHD University Hospital, Grenoble
  More Information

Publications:
Responsible Party: AdministrateurCIC, Dr Véronique EQUY, University Hospital, Grenoble., University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01058200     History of Changes
Other Study ID Numbers: DCIC 07 23
Study First Received: January 27, 2010
Last Updated: July 19, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on October 19, 2014