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Pubmed for Handhelds

PUBMED FOR HANDHELDS

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  • Title: A randomised controlled trial of a new handheld vacuum extraction device.
    Author: Attilakos G, Sibanda T, Winter C, Johnson N, Draycott T.
    Journal: BJOG; 2005 Nov; 112(11):1510-5. PubMed ID: 16225571.
    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) = 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.
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