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

NCT01058200 | Completed Phase 3 DMC

• 1 other identifier: DCIC 07 23
• Study Type: interventional
• Target: 668
• Locations: 1 country
• Sites: 6

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

Conditions

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

Outcome Measures

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'

  one day

Secondary Outcomes (3)

• maternal lesions: cervix lesions, postpartum haemorrhage

  28 days maximum

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

  28 days maximum

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

  28 days maximum

Study Arms (2)

vacuum extractor 'iCUP'

ACTIVE COMPARATOR

new vacuum extractor: sterile disposable plastic cup

Device: iCup

reference vacuum extractor

SHAM COMPARATOR

reference cup of the obstetrical ward: metallic cup

Device: reference cup

Interventions

iCup DEVICE

new vacuum extractor: sterile disposable plastic cup

vacuum extractor 'iCUP'

reference cup DEVICE

reference cup of the obstetrical ward: metallic cup

reference vacuum extractor

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (6)

University Hospital

Besançon, 25000, France

Location

University Hospital

Caen, 14000, France

Location

Hospital

Chambéry, 73000, France

Location

University Hospital

Clermont-Ferrand, 63000, France

Location

University Hospital

Grenoble, 38000, France

Location

University Hospital

Strasbourg, 67000, France

Location

Related Publications (11)

• 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.

  PMID: 2757977 BACKGROUND

• 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.

  PMID: 10796203 BACKGROUND

• 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.

  PMID: 11711908 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 16225571 BACKGROUND

• 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.

  PMID: 16553663 BACKGROUND

• 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.

  PMID: 16411996 BACKGROUND

• 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.

  PMID: 19268200 BACKGROUND

• 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.

  PMID: 19268198 BACKGROUND

• 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.

  PMID: 34559884 DERIVED

• 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.

  PMID: 26666981 DERIVED

Study Officials

• Jean-Patrick SCHAAL, MD PHD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Véronique EQUY, University Hospital, Grenoble.

Study Record Dates

• First Submitted: January 27, 2010
• First Posted: January 28, 2010
• Study Start: October 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 22, 2013

Record last verified: 2013-07

Locations

FR (6)