A randomised controlled trial of a new handheld vacuum extraction device

Abstract

Objective To evaluate the effectiveness of a new handheld vacuum delivery device.Design Randomised controlled trial.Setting Southmead Hospital, Bristol, UK.Population 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. Main outcome measures 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) ¼ 1.

Qualitative analysis by interviews and video recordings to establish the components of a skilled low‐cavity non‐rotational vacuum delivery

“…7 The disposable rigid vacuum devices have been reported to have failure rates of up to 34%. 8,9 This supports the argument for better training to conduct operative vaginal deliveries. 10,11 Currently, the trainee operator's level of expertise depends on the number of procedures carried out and on the knowledge, skill and enthusiasm of the teacher.…”

Trials and tribulations of operative vaginal delivery

“…Judging by recent reports from other teaching institutions in the UK, failure rates for vacuum extraction of 20% or higher are not uncommon. 13,14 Clearly, the DDI will be influenced by the number of failed procedures that are followed by additional methods to complete the delivery.…”

Novel Simulation Workshop Improves Performance in Vacuum Delivery

“…As previous clinical studies have shown [3] [7]- [9], this is expected to lead to an improvement in clinical outcomes by decreasing vacuum delivery failure rates, especially in mal positions. In each of the three workshops the participants independently developed the same technique for cup insertion.…”

“…There is a wide variation between reported failure rates depending on the fetal head position, the choice of cup and the skill of the accoucheur [8] [9]. Failure rates differ with different types of cup used [2] but even using the same cup (Kiwi Omnicup) failure rates vary from 2% to 34% [3] [7] [10]. It is widely accepted that the key to minimising failure rates and fetal trauma is accurate cup placement over the flexion point [4] [10] [11].…”