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Completed

NCT Number: NCT01058200

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

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

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital, Besançon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iCup

Device

new vacuum extractor: sterile disposable plastic cup

reference cup

Device

reference cup of the obstetrical ward: metallic cup

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: ICUP

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jan 28, 2010
Registry last updated
Jul 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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