Abstract
Objective: To evaluate the performance and safety in clinical practice of a new obstetric device, the Kiwi OmniCup Vacuum Delivery System.Study design: Kiwi OmniCup devices were used in 20 low- and mid-cavity-assisted delivery procedures, where a valid indication for expediting the birth existed and where vacuum delivery was considered to be appropriate. In each case, information recorded about the procedure included fetal position, cup safety, ease of use, details of use, and effects on the mother and infant.Results: The Kiwi OmniCup Vacuum Delivery System performed well in all of the 20 vacuum extractions. The OmniCup was easy to insert into the vagina. The unique design features enabled the cup to be maneuvered within the birth canal and be placed over the correct site on the fetal head in nearly all cases, irrespective of the position of the fetal head. The cup adhered well to the fetal head without detachment, and all deliveries were accomplished successfully. Regarding safety of the device, there were no maternal injuries reported and, apart from a transient cephalohematoma in one infant, there were no fetal injuries.Conclusions: Clinical use of the Kiwi OmniCup demonstrated that the device, if used correctly, is safe and functionally effective.
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