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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vacuum extractor 'iCUP' | Active Comparator | new vacuum extractor: sterile disposable plastic cup |
|
| reference vacuum extractor | Sham Comparator | reference cup of the obstetrical ward: metallic cup |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iCup | Device | new vacuum extractor: sterile disposable plastic cup |
| |
| Measure | Description | 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' | one day |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Patrick SCHAAL, MD PHD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Besançon | 25000 | France | |||
| University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2757977 | Background | 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. | |
| 10796203 | 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. |
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| reference cup |
| Device |
reference cup of the obstetrical ward: metallic cup |
|
| medico-economic criteria: cost-effectiveness analysis of the studied medical devices |
| 28 days maximum |
| Caen |
| 14000 |
| France |
| Hospital | Chambéry | 73000 | France |
| University Hospital | Clermont-Ferrand | 63000 | France |
| University Hospital | Grenoble | 38000 | France |
| University Hospital | Strasbourg | 67000 | France |
| 11711908 | 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. |
| Background | Schaal JP, Riethmuller D, Menget A. Extractions instrumentales du fœtus : ventouse obstétricale. Encycl Méd Chir Paris: Elsevier, 2004 (vol Obstétrique) |
| 16225571 | 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. |
| 16553663 | 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. |
| 16411996 | 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. |
| 19268200 | 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. |
| 19268198 | 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. |
| 41258537 | Derived | 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. |
| 34559884 | Derived | 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. |
| 26666981 | 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. |