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

July 19, 2013 updated by: AdministrateurCIC, University Hospital, Grenoble

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

668

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25000
        • University Hospital
      • Caen, France, 14000
        • University Hospital
      • Chambéry, France, 73000
        • Hospital
      • Clermont Ferrand, France, 63000
        • University Hospital
      • Grenoble, France, 38000
        • University Hospital
      • Strasbourg, France, 67000
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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'
Time Frame: one day
one day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Jean-Patrick SCHAAL, MD PHD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

January 27, 2010

First Submitted That Met QC Criteria

January 27, 2010

First Posted (ESTIMATE)

January 28, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 22, 2013

Last Update Submitted That Met QC Criteria

July 19, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • DCIC 07 23

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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