Clinical trial NCT01058200: a Randomized Multicenter Trial Comparing Vacuum Assisted Delivery With the New Device "iCUP" Versus the Reference Cup.
Official title: Assess the Risk-benefit Balance of the New Vacuum Assisted-delivery Device "iCUP" Versus the Reference Vacuum. Multicenter Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vacuum Extraction, Obstetrical
Randomized Controlled Trials
Failures, Medical Device
Maternal Lesions
Neonatal Lesions
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2010-01-28
Enrollment: 668
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
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'
timeFrame: one day
Secondary outcomes:
measure: maternal lesions: cervix lesions, postpartum haemorrhage
timeFrame: 28 days maximum
measure: neonatal lesions: minor scalp injuries, Apgar score < 7, pH < 7.20, anaemia, jaundice, transfer
timeFrame: 28 days maximum
measure: medico-economic criteria: cost-effectiveness analysis of the studied medical devices
timeFrame: 28 days maximum
Other outcomes:
Locations:
city: Besançon
country: France
facility: University Hospital
city: Caen
country: France
facility: University Hospital
city: Chambéry
country: France
facility: Hospital
city: Clermont Ferrand
country: France
facility: University Hospital
city: Grenoble
country: France
facility: University Hospital
city: Strasbourg
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Grenoble
name: Jean-Patrick SCHAAL, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Schaal JP, Riethmuller D, Menget A. Extractions instrumentales du fœtus : ventouse obstétricale. Encycl Méd Chir Paris: Elsevier, 2004 (vol Obstétrique)
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.