Clinical Validation of a Simple to Use, Disposable and Inexpensive Device for Safe Extraction of the Fetus During Emergency Cases of Shoulder Dystocia Thereby Preventing Both Fetal and Maternal Injury and Death in Developing Countries and Worldwide

Organization: 
Fetalease Limited
Organization Location: 
Zichron Yaacov, Israel

Current estimates suggest that 1.5% of vaginal deliveries involve Shoulder Dystocia (SD), which causes fetal injury, permanent disability and death. Maternal morbidity can also be caused by postpartum hemorrhage and more. Current management of SD is by a sequence of manual maneuvers - known to pose the risk of injury to the fetus such as Brachial Plexus Injury (BPI) - for delivering the shoulders. Worldwide figures for BPI do not exist. Extrapolation from published reports suggests that worldwide over 50K newborns sustain permanent BPI annually.

SD may be prevented by identifying risk factors that predict its occurrence, and delivering the fetus by Cesarean Section (CS). This approach is limited and leads to an unacceptable number of CS performed to prevent 1 case of SD. This approach cannot be implemented in rural settings where CS cannot be readily offered. Attempts to develop devices (e.g., shoehorn) to assist in the resolution of SD have not succeeded.  

This simple disposable extraction device consists of two plastic coated metal arms and a silicone engagement element which conforms to the maternal and fetal anatomy. Tests conducted on models show that the shoulder can be delivered easily with minimal pressure on fetal and maternal tissues. The device is low-cost, simple and can be easily taught to lower-skilled birth attendants. Funding will be used to conduct clinical efficacy testing in a number of countries where care may be provided by less trained personnel and the safe alternative of delivery by a CS cannot be offered. Positive results will support the device’s adoption by medical organizations in these countries.