Clinical impact of the disposable ventouse iCup® versus a metallic vacuum cup: a multicenter randomized controlled trial

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.Electronic supplementary materialThe online version of this article (doi:10.1186/s12884-015-0771-1) contains supplementary material, which is available to authorized users.

Assisted Vaginal Birth

“…A trial of 666 women in France comparing the metal vacuum with the disposable iCup TM reported higher failure with the disposable cup (35.6% versus 7.1%; P < 0.0001). 87 A further trial in Papua New Guinea reported low rates of vacuum failure of 2/100 for the Kiwi TM Omnicup and 6/100 for the Bird metal cup. 88 A prospective cohort study of 1000 vacuum-assisted births with the Kiwi TM OmniCup reported a failure rate of 12.9%.…”

“…Failure of vacuum birth was three to four times more likely with a fetal malposition. A trial of 666 women in France comparing the metal vacuum with the disposable iCup TM reported higher failure with the disposable cup (35.6% versus 7.1%; P < 0.0001) . A further trial in Papua New Guinea reported low rates of vacuum failure of 2/100 for the Kiwi™ Omnicup and 6/100 for the Bird metal cup .…”

Novel Simulation Workshop Improves Performance in Vacuum Delivery

“…The rate of vacuum delivery in Australia is 8% [1], which is similar to rates in the UK, France and the United States [2]- [4]. Operative vaginal delivery may be undertaken for fetal indications such as fetal distress, or for maternal indications such as failure to progress or maternal exhaustion [2] [4].…”

“…There is a wide variation between reported failure rates depending on the fetal head position, the choice of cup and the skill of the accoucheur [8] [9]. Failure rates differ with different types of cup used [2] but even using the same cup (Kiwi Omnicup) failure rates vary from 2% to 34% [3] [7] [10]. It is widely accepted that the key to minimising failure rates and fetal trauma is accurate cup placement over the flexion point [4] [10] [11].…”

“…Consequences for the baby can include minor trauma such as cephalhaematoma in up to 13.6% [5] [6] in addition to potentially fatal trauma such as subgaleal haemorrhage in up to 21% of vacuum deliveries [6], with inaccurate placement of the cup being a significant contributor to the more severe cases [5] [7]. Vacuum delivery also carries a risk of maternal trauma [2], particularly in cases where the vacuum fails to deliver the baby and either a second instrument is required, or a caesarean delivery results. There is a wide variation between reported failure rates depending on the fetal head position, the choice of cup and the skill of the accoucheur [8] [9].…”