Abstract
Introduction: A national perinatal survey in France in 2016 showed that 12.2% of women have instrumentally assisted vaginal births with vacuum extraction used in 49.8% of cases, making it the most frequently used form of obstetrical assistance. The 2006 initial concept of the Icup® vacuum extractor was based on the development of a single-use device with a partially deformable cup to avoid any fetal scalp injury. However, owing to a significant rate of premature cup detachment, this first device required technical improvements which resulted in a new version: the Icup2® which obtained the CE label in February 2017. The main objective of this preliminary study was to assess the efficacy of this new obstetrical vacuum extractor.
Method: A preliminary retrospective observational study was undertaken in one hospital from February to October 2017. In our current practice, we use mainly Drapier-Faure’s obstetrical vacuum device Minicup®. We evaluated ICup2® through a descriptive study of quantitative and qualitative data and an analysis of its success rate as well as the rates of fetal scalp and perineal injuries.
Results: Fifty-eight assisted deliveries using the Icup2® were carried out by 9 experienced operators. The success rate of the Icup2® was 91.4 %. The premature cup detachment rate was 17.2%. No significant fetal scalp injury was noted.
Conclusion: This new low-cost and highly effective French device meets the required conditions for instrumentally assisted deliveries. Following this preliminary study, a prospective multi-centred comparative study will be conducted.
Keywords
Obstetrical vacuum device, Assisted instrumental delivery