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Updated: Aug 15, 2026
Capturing Actively Produced Microbial Volatile Organic Compounds from Human-Associated Samples with Vacuum-Assisted Sorbent Extraction
Published on: June 1, 2022
A randomised controlled trial of a new handheld vacuum extraction device
G Attilakos1, T Sibanda, C Winter
1Department of Obstetrics and Gynaecology, Southmead Hospital, North Bristol NHS Trust, Bristol, UK.
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) = 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.