A prospective observational study of 1000 vacuum assisted deliveries with the OmniCup device.

OBJECTIVE: To determine the maternal and perinatal outcomes associated with delivery by the rigid plastic OmniCup vacuum delivery device.

METHODS: We conducted a prospective observational study of 1000 consecutive vacuum-assisted deliveries using the OmniCup vacuum device in singleton pregnancies. The relationship of the cup application to the flexion point was independently observed after delivery and related to the neonatal outcome, including scalp trauma.

RESULTS: Of the 1000 women, 70% were nulliparous and 30% parous (> or = para 1). In 87.1% of the women, vacuum-assisted delivery was completed; spontaneous or forceps delivery occurred in 10.9%, and Caesarean section was performed in 2%. The vacuum was applied for < or = 10 minutes in 97.4% of deliveries, < or = 3 pulls were required in 95.6%, and < or = 25 lb traction force was required in 85.7% of cases. There was a statistically significant relationship between unfavourable cup applications (deflexing and paramedian) and scalp trauma in infants born to nulliparous women (P < 0.01). Four cases of neonatal intracranial hemorrhage (0.4%) were identified, and three of these infants were subsequently neurodevelopmentally normal. There was one subgaleal hemorrhage.

CONCLUSIONS: There is a relationship between unfavourable cup application during vacuum assisted delivery and neonatal scalp trauma in infants born to nulliparous women.