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.
Highlights
Assisted vaginal delivery by vacuum extraction is frequent
Ninety women who in the end did not meet the inclusion criteria were subsequently excluded, as foreseen in the protocol, and the 578 mothers requiring vacuum extractions and their new-borns were followed and analysed (Fig. 1). These exclusions were similar in both groups and concerned 71 mothers who did not require instrumental extraction and 18 mothers unable to have a vacuum extraction (10 women in the ‘disposable cup’ group: two with forceps extraction first and eight with other exclusion criteria; and 9 women in the ‘metallic cup’ group: one with forceps extraction first, seven with other exclusion criteria including one withdrawal of consent)
Perineal tears were more frequent in the metallic cup group, especially for third or fourth grade perineal tears: 1.7 % versus 5.0 %, p = 0.003
Summary
Assisted vaginal delivery by vacuum extraction is frequent. In the last few years a new disposable semi-soft vacuum extraction cup, the iCup, has been introduced. In France the most frequently used metallic cup is the Drapier-Faure MiniCup® (Collin-Gentile-Drapier, Paris, France). It has a rigid cup with a vacuum aspiration system independent of the traction system. The disposable Kiwi OmniCup® (Clinical Innovations, Heathrow, UK) ventouse has a rigid plastic cup with an integrated hand-held vacuum connection that allows both aspiration and traction [6,7,8]. The new iCup® vacuum cup is disposable and has a 5 cm diameter cup with a central traction strap and a flexible suction tube leading to an electric pump. The cup is made from a rigid plastic material, but the part of the cup in contact with the foetal scalp is made of polyurethane, a soft plastic material with adherent properties (Gyneas, Goussainville, France)
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