There are over 130 million live births each year. The United States accounts for approximately 4 million of these with 27% of deliveries requiring induction of labor. The Centers for Disease Control (CDC) estimates that 32% of deliveries occur via caesarean section (c-section), a figure that is much higher than the World Health Organization’s (WHO) recommendation of 10-15%. C-section delivery in the United States is associated with elevated risks including a 3-fold increase in maternal death, as well as an additional $25 billion in annual healthcare costs.
There is a medical, economic, and social will to reduce the rate of the c-section, which is the world’s most common surgical procedure. CDC data shows implies the largest cause of c-section is a prior c-section. This is because scarring from the procedure increases the risk of uterine rupture in later pregnancies. First time (primary) c-sections are the result of many possible indications, but the majority of these (fetal tracings and labor arrest) have clinical definitions related to time. Increasing the rate of cervical dilation and delivery should reduce the rate of c-sections.
Existing methods of labor induction are based on only a partial understanding of cervical ripening and dilation. Our approach uses a novel, patent-pending modification of traditional dilation balloon methods wherein a syringe-like pump actively compensates for cervical effacement and mimics the forces of natural contractions. This dynamic force induces cyclic stress on cervical fibroblast to hasten the ripening cascade. Since the device does not induce uterine contractions, it will be safe to use for VBAC attempts.
Indications for primary c-section.