Trial reportBMC pregnancy and childbirth2015
Clinical impact of the disposable ventouse iCup® versus a metallic vacuum cup: a multicenter randomized controlled trial.
Trial report in BMC pregnancy and childbirth, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01058200 (Assess the Risk-benefit Balance of the New Vacuum Assisted-delivery Device "iCUP" Versus the Reference Vacuum. Multicenter Prospective Randomized Controlled Study), which is not on this map. Cited by 6 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Assess the Risk-benefit Balance of the New Vacuum Assisted-delivery Device "iCUP" Versus the Reference Vacuum. Multicenter Prospective Randomized Controlled Study
Who cites it
6 citing papers in PubMed, 3 syntheses or guidelines pooled it, 12 citations in OpenAlex.
- Effectiveness of Perineal Protection Devices in Reducing Birth-Related Perineal Trauma: A Systematic Review and Meta-Analysis of Randomized Controlled Trials and GRADE Assessment.International urogynecology journal · 2026Pooled it
- Instruments for assisted vaginal birth.The Cochrane database of systematic reviews · 2021Pooled it
- Exploring the reporting standards of RCTs involving invasive procedures for assisted vaginal birth: A systematic review.European journal of obstetrics, gynecology, and reproductive biology · 2021Pooled it
- IUGA International Guidelines on Obstetric Anal Sphincter Injuries.International urogynecology journal · 2026Article
- Episiotomy is associated with a reduced risk of obstetric anal sphincter injury in nulliparous vacuum-assisted deliveries, particularly in high-risk cases.Acta obstetricia et gynecologica Scandinavica · 2026Article
- Intrapartum Ultrasound in Vacuum Operative Delivery: A Comprehensive Review and Proposal of the Novel Ultrasound Flexion Point Method.Diagnostics (Basel, Switzerland) · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 7 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAssisted vaginal delivery by vacuum extraction is frequent. Metallic resterilizible metallic vacuum cups have been routinely used in France. In the last few years a new disposable semi-soft vacuum extraction cup, the iCup, has been introduced. Our objective was to compare maternal and new-born outcomes between this disposable cup and the commonly used Drapier-Faure metallic cup.
methodsThis was a multicenter prospective randomized controlled open clinical trial performed in the maternity units of five university hospitals and one community hospital in France from October 2009 to February 2013. We included consecutive eligible women with a singleton gestation of at least 37 weeks who required vacuum assisted delivery. Women were randomized to vacuum extraction using the iCup or usual Drapier-Faure metallic cup. The primary outcome was a composite criterion including both the risk of cup dysfunction and the most frequent maternal and neonatal harms: the use of other instruments after attempted vacuum extraction, caesarean section after attempted vacuum extraction, three detachments of the cup, caput succedaneum, cephalohaematoma, episiotomy and perineal tears.
results335 women were randomized to the disposable cup and 333 to extraction using the metallic cup. There was no significant difference between the two groups for the primary outcome. However, failed instrumental delivery was more frequent in the disposable cup group, mainly due to detachment: 35.6 % vs 7.1 %, p < 0.0001. Conversely, perineal tears were more frequent in the metallic cup group, especially third or fourth grade perineal tears: 1.7 % versus 5.0 %, p = 0.003. There were no significant differences between the two groups concerning post-partum haemorrhage, transfer to a neonatal intensive care unit (NICU) or serious adverse events.
conclusionsWhile the disposable cup had more detachments and extraction failures than the standard metallic cup, this innovative disposable device had the advantage of fewer perineal injuries.
trial registrationwww.clinicaltrials.gov : NCT01058200 on Jan. 27 2010.
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