Expandable cervical pessary device to treat cervical incompetence.
- Inflatable device can adapt to any size.
- Eliminates need for sutures or cervical tape, reducing risk of cervical trauma.
Cervical incompetence is a premature dilation and effacement (cervical ripening) during the second trimester of pregnancy and often leads to miscarriage or preterm birth. It accounts for 9% of all preterm births and 3% of infant deaths in the US. Pessaries are medical devices inserted into the vagina to aid in supporting the cervix, treat cervical incompetence and deliver medication. Commercially available pessaries are fixed sizes, making them often uncomfortable and ineffective. Pessaries are often used in conjunction with, or instead of cervical cerclage, an invasive procedure whereby a stitch is placed in the cervix to secure closure until the end of the gestational period. The cerclage procedure may cause cervical trauma and may inadvertently puncture the amniotic sac.
Researchers have developed an inflatable pessary to aid in treatment of cervical incompetence. The device may be inserted in a deflated state, then inflated to the appropriate size during a routine visit. The inflatable design allows this pessary to be adaptable for any patient size. This device can be used to prevent pre-term birth and avoid complications associated with cervical cerclage in patients with a history of pre-term birth or premature rupture of membranes (PROM).
Prototype has been developed.