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A Pilot Study To Evaluate The Preliminary Safety And Feasibility Of The Materna Medical Device
Description

The Materna device aims to prevent pelvic tissue damage by preventing overstretching of pelvic floor muscle fibers during delivery. The device is a single use, disposable, mechanical dilator that penetrates the first 4 cm or ½ of the vaginal canal and gradually expands the vagina from a resting diameter of 2-3 cm to the fully expanded size of a delivering fetus, roughly 8-10 cm. The Materna device will be used during the first stage of labor, for roughly 1-2 hours, in a hospital Labor and Delivery unit, under the supervision of trained clinical labor and delivery providers