title: Clinical impact of the disposable ventouse iCup® versus a metallic vacuum cup: a multicenter randomized controlled trial.
abstract: BACKGROUND
  Assisted 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.
  
  
  METHODS
  This 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.
  
  
  RESULTS
  335 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.
  
  
  CONCLUSIONS
  While 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.
  
  
  BACKGROUND
  www.clinicaltrials.gov : NCT01058200 on Jan. 27 2010.
authors.affiliation: Obstetrical Care Unit, 'Hôpital Couple Enfant', Grenoble University Hospital, CS 10217, 38043, Grenoble cedex 09, France. VEquy@chu-grenoble.fr.
authors.forename: Véronique
authors.initials: V
authors.lastname: Equy
authors.affiliation: Grenoble University Hospital, Clinical and Medico-economic Evaluation Unit - Clinical Research and Innovation Department, Grenoble University Hospital, 38000, Grenoble, France. SDavidtchouda@chu-grenoble.fr.|TIMC-Imag UMR 5525, Université Grenoble Alpes, 38000, Grenoble, France. SDavidtchouda@chu-grenoble.fr.
authors.forename: Sandra
authors.initials: S
authors.lastname: David-Tchouda
authors.affiliation: Obstetrical Care Unit, 'Hôpital Femme Enfant', Caen University Hospital, 14033, Caen, France. dreyfus-m@chu-caen.fr.
authors.forename: Michel
authors.initials: M
authors.lastname: Dreyfus
authors.affiliation: Obstetrical Care Unit, 'Pôle Mère-Femme', Besançon University Hospital, 25030, Besançon, France. didier.riethmuller@univ-fcomte.fr.
authors.forename: Didier
authors.initials: D
authors.lastname: Riethmuller
authors.affiliation: Obstetrical Care Unit, Site Estaing, Clermont-Ferrand University Hospital, 1 place Lucie et Raymond Aubrac, 63003, Clermont-Ferrand Cedex 1, France. fvendittelli@chu-clermontferrand.fr.|Université d'Auvergne, EA 4681, PEPRADE (Périnatalité, grossesse, Environnement, PRAtiques médicales et DEveloppement), Clermont University, Université d'Auvergne, 63001, Clermont-Ferrand, France. fvendittelli@chu-clermontferrand.fr.
authors.forename: Françoise
authors.initials: F
authors.lastname: Vendittelli
authors.affiliation: Obstetrical Care Unit, Chambéry Hospital, 73011, Chambéry, France. victoire.cabaud@ch-chambery.fr.
authors.forename: Victoire
authors.initials: V
authors.lastname: Cabaud
authors.affiliation: Obstetrical Care Unit, 'Hôpital Hautepierre', Strasbourg University Hospital, 67098, Strasbourg, France. bruno.langer@chru-strasbourg.fr.
authors.forename: Bruno
authors.initials: B
authors.lastname: Langer
authors.affiliation: Grenoble University Hospital, Clinical and Medico-economic Evaluation Unit - Clinical Research and Innovation Department, Grenoble University Hospital, 38000, Grenoble, France. JMargier@chu-grenoble.fr.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Margier
authors.affiliation: TIMC-Imag UMR 5525, Université Grenoble Alpes, 38000, Grenoble, France. jean-luc.bosson@imag.fr.|INSERM CIC 1406, Grenoble University Hospital, 38000, Grenoble, France. jean-luc.bosson@imag.fr.
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Bosson
authors.affiliation: Obstetrical Care Unit, 'Hôpital Couple Enfant', Grenoble University Hospital, CS 10217, 38043, Grenoble cedex 09, France.
authors.forename: Jean-Patrick
authors.initials: JP
authors.lastname: Schaal
mesh_terms: D000328:Adult; D001720:Birth Injuries / Q000453:epidemiology; D004841:Episiotomy; D005260:Female; D005602:France; D006801:Humans; D007231:Infant, Newborn; D007363:Intensive Care Units, Neonatal; D022125:Lacerations / Q000453:epidemiology; D010502:Perineum / Q000293:injuries; D006473:Postpartum Hemorrhage / Q000453:epidemiology; D011247:Pregnancy; D011446:Prospective Studies; D014620:Vacuum Extraction, Obstetrical / Q000009:adverse effects / Q000295:instrumentation*; D055815:Young Adult