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Vacuum Extraction, ObstetricalPhase 3ICUPNCT01058200

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

A Phase 3 study testing iCup and reference cup in people with Vacuum Extraction, Obstetrical and Randomized Controlled Trials, run by University Hospital, Grenoble at 6 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 45 years, women only
What is being tested?
iCup and reference cup
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
668 participants
Where
6 sitesFrance
Study dates
Oct 2009to Jun 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • no informed consent
  • singleton delivery before 37 weeks, in non-cephalic presentation,
  • patient deprived of freedom

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

France6 sites

  • University Hospital

    Besançon, 25000

  • University Hospital

    Caen, 14000

  • Hospital

    Chambéry, 73000

  • University Hospital

    Clermont-Ferrand, 63000

  • University Hospital

    Grenoble, 38000

  • University Hospital

    Strasbourg, 67000

Other trials in France

About this study

Official title: 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

Read the 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.

Being tested
iCup, reference cup

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iCupDevice

    new vacuum extractor: sterile disposable plastic cup

  • reference cupDevice

    reference cup of the obstetrical ward: metallic cup

Study groups in NCT01058200
Study groupRoleWhat they receive
vacuum extractor 'iCUP'Active comparatornew vacuum extractor: sterile disposable plastic cup
Receives: Device: iCup
reference vacuum extractorSham comparatorreference cup of the obstetrical ward: metallic cup
Receives: Device: reference cup

What is being measured

The primary outcome is the main question the study is designed to answer.

  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'

    Measured: one day

Secondary outcomes (3)

  1. maternal lesions: cervix lesions, postpartum haemorrhage

    Measured: 28 days maximum

  2. neonatal lesions: minor scalp injuries, Apgar score < 7, pH < 7.20, anaemia, jaundice, transfer

    Measured: 28 days maximum

  3. medico-economic criteria: cost-effectiveness analysis of the studied medical devices

    Measured: 28 days maximum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2010 (estimated)
  2. Study startOct 2009
  3. Primary completionJun 2012
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
668 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01058200
Sponsor's protocol ID
DCIC 07 23
Acronym
ICUP
Status last verified
Jul 2013
First submitted
27 Jan 2010
Last updated
22 Jul 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Chalmers JA, Chalmers I. The obstetric vacuum extractor is the instrument of first choice for operative vaginal delivery. Br J Obstet Gynaecol. 1989 May;96(5):505-6. doi: 10.1111/j.1471-0528.1989.tb03246.x. No abstract available.

    PubMed 2757977

  • Johanson R, Menon V. Soft versus rigid vacuum extractor cups for assisted vaginal delivery. Cochrane Database Syst Rev. 2000;(2):CD000446. doi: 10.1002/14651858.CD000446.

    PubMed 10796203

  • Miksovsky P, Watson WJ. Obstetric vacuum extraction: state of the art in the new millennium. Obstet Gynecol Surv. 2001 Nov;56(11):736-51. doi: 10.1097/00006254-200111000-00025.

    PubMed 11711908

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

  • Attilakos G, Sibanda T, Winter C, Johnson N, Draycott T. A randomised controlled trial of a new handheld vacuum extraction device. BJOG. 2005 Nov;112(11):1510-5. doi: 10.1111/j.1471-0528.2005.00729.x.

    PubMed 16225571

  • Vacca A. A randomised controlled trial of a new handheld vacuum extraction device. BJOG. 2006 Apr;113(4):492; author reply 494-5. doi: 10.1111/j.1471-0528.2006.00903.x. No abstract available.

    PubMed 16553663

  • Groom KM, Jones BA, Miller N, Paterson-Brown S. A prospective randomised controlled trial of the Kiwi Omnicup versus conventional ventouse cups for vacuum-assisted vaginal delivery. BJOG. 2006 Feb;113(2):183-9. doi: 10.1111/j.1471-0528.2005.00834.x.

    PubMed 16411996

  • Schaal JP, Equy V, Hoffman P. [Comparison vacuum extractor versus forceps]. J Gynecol Obstet Biol Reprod (Paris). 2008 Dec;37 Suppl 8:S231-43. doi: 10.1016/S0368-2315(08)74761-6. French.

    PubMed 19268200

  • Riethmuller D, Ramanah R, Maillet R, Schaal JP. [Vacuum extractors: description, mechanics, indications and contra-indications]. J Gynecol Obstet Biol Reprod (Paris). 2008 Dec;37 Suppl 8:S210-21. doi: 10.1016/S0368-2315(08)74759-8. French.

    PubMed 19268198

  • Allam S, Abdelkader OKS, Mansour R, Elsayed N, Elshiekh H, Tarabishi J, Hegazy SM, Arafa A, Kertam A. Effectiveness of Perineal Protection Devices in Reducing Birth-Related Perineal Trauma: A Systematic Review and Meta-Analysis of Randomized Controlled Trials and GRADE Assessment. Int Urogynecol J. 2026 Feb;37(2):261-275. doi: 10.1007/s00192-025-06364-y. Epub 2025 Nov 19.

    PubMed 41258537

  • Verma GL, Spalding JJ, Wilkinson MD, Hofmeyr GJ, Vannevel V, O'Mahony F. Instruments for assisted vaginal birth. Cochrane Database Syst Rev. 2021 Sep 24;9(9):CD005455. doi: 10.1002/14651858.CD005455.pub3.

    PubMed 34559884

  • Equy V, David-Tchouda S, Dreyfus M, Riethmuller D, Vendittelli F, Cabaud V, Langer B, Margier J, Bosson JL, Schaal JP. Clinical impact of the disposable ventouse iCup(R) versus a metallic vacuum cup: a multicenter randomized controlled trial. BMC Pregnancy Childbirth. 2015 Dec 15;15:332. doi: 10.1186/s12884-015-0771-1.

    PubMed 26666981

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing iCup and reference cup in people with Vacuum Extraction, Obstetrical and Randomized Controlled Trials, run by University Hospital, Grenoble at 6 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01058200, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2013.

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