title: A randomised controlled trial of a new handheld vacuum extraction device.
abstract: OBJECTIVE
  To evaluate the effectiveness of a new handheld vacuum delivery device.
  
  
  METHODS
  Randomised controlled trial.
  
  
  METHODS
  Southmead Hospital, Bristol, UK.
  
  
  METHODS
  One hundred and ninety-four women requiring delivery with vacuum extraction.
  
  
  METHODS
  Women were recruited into the study while still in early labour. If during delivery, vacuum extraction was indicated they were then randomly allocated to either a new handheld vacuum device, the Kiwi Omnicup, or to a 'standard' vacuum cup selected by the obstetrician. The 'standard group' consisted of the silastic (66/98, 67%) or the metal cups (32/98, 33%). Study data were recorded at completion of the delivery and at 24-48 hours. An additional brief symptom questionnaire was completed by the mother at 10 days postnatally. Statistical analyses were done on an 'intention-to-treat' basis.
  
  
  METHODS
  The primary outcome was the successful completion of delivery with the allocated instrument. Secondary outcomes were substantial fetal scalp trauma and substantial maternal trauma.
  
  
  RESULTS
  The Omnicup was associated with a significantly higher failure rate than the standard cup [34%vs 21%, odds ratio (OR) = 1.9 (1.01-3.6)]. This difference persisted after adjusting for confounding factors [adjusted OR = 2.25 (1.01-5.0)] and resulted in significantly more forceps deliveries in the Kiwi Omnicup group [22%vs 10%, unadjusted OR = 2.5 (1.1-5.5)]. The caesarean section rates were similar in both groups [9.4%vs 8.2%, OR = 1.2 (0.4-3.2)]. Rates of substantial scalp trauma and maternal trauma were similar in both groups. However, there were more cases of jaundice in the standard cup group [2.3%vs 12.0%, unadjusted OR = 0.18 (0.04-0.82) and adjusted OR = 0.10 (0.01-0.88)].
  
  
  CONCLUSIONS
  The Omnicup is not as successful at achieving a vaginal delivery as the combination of the currently used vacuum cups.
authors.affiliation: Department of Obstetrics and Gynaecology, Southmead Hospital, North Bristol NHS Trust, Bristol, UK.
authors.forename: G
authors.initials: G
authors.lastname: Attilakos
authors.forename: T
authors.initials: T
authors.lastname: Sibanda
authors.forename: C
authors.initials: C
authors.lastname: Winter
authors.forename: N
authors.initials: N
authors.lastname: Johnson
authors.forename: T
authors.initials: T
authors.lastname: Draycott
mesh_terms: D005260:Female; D005316:Fetal Distress / Q000628:therapy*; D006801:Humans; D007744:Obstetric Labor Complications / Q000628:therapy*; D010298:Parity; D011247:Pregnancy; D011256:Pregnancy Outcome; D011644:Puerperal Disorders / Q000209:etiology; D014620:Vacuum Extraction, Obstetrical / Q000009:adverse effects / Q000295:instrumentation*