Reinventing Management of Fetal Head Impaction

BACKGROUND: Fetal head impaction is a life threatening event that occurs when the baby's head does not fit through the birth canal and becomes wedged deep in the pelvis during labor. Since the baby's head cannot advance, a cesarean section must be performed, often with significant complications caused by the difficulty of dislodging the fetal head from the mother's pelvis, and elevation of the fetal head in the uterus towards the cesarean incision. Physicians use complicated and violent maneuvers such as pulling on baby's legs and pushing on the baby's head with the tips of their fingers to release the impaction. The use of these maneuvers results in poor maternal and fetal outcomes including risk of intracranial hemorrhage, lower APGAR scores, maternal hemorrhage, thromboembolism, and infection, as well as added psychological and financial burden for families. Fetal head impaction presents to some degree in 25% of all C-sections, translating to approximately 320,000 cases annually in the U.S. Although prevalent, little has yet been done to fully quantify its health burden or propose alternative ways to resolve impaction. OBJECTIVE: To determine whether a novel obstetrics device for facilitating C-section in cases of fetal head impaction would be both financially viable and technically feasible. METHODS: In order to estimate the rate of complications and healthcare costs associated with fetal head impaction in the U.S., we first used published literature to identify the diagnosis codes related to fetal head impaction. Utilizing these, we queried a national database of diagnosis codes for associated complications and then matched these complications to their corresponding hospital charges and costs. With the feedback of practicing obstetricians, we built a prototype device to facilitate delivery in cases of fetal head impaction with emergency cesarean section. We tested the device with a formal fetal head impaction simulator to measure pressure exerted and rate of disimpaction to facilitate a cesarean delivery. We then compared this to the gold standard, manual disimpaction. RESULTS: We have found that C-section deliveries with associated with failure to progress, a proxy for fetal head impaction, result in $1,444 in added direct hospital costs in cases resulting in complication versus those resulting in no complication. We have further found that our prototype device generates 94% less pressure than the current standard of care while facilitating rapid disimpactions that are difficult to achieve manually on a fetal impaction simulator. Finally, we estimate an addressable market given projected device development costs, and outline a strategy by which this novel device could be brought to patient care. CONCLUSION: Preliminary prototype testing suggests that the Safe-C Pump could improve upon the standard of care by facilitating rapid, low-pressure disimpactions. Clinical testing of efficacy will be necessary to determine whether the device will be able to achieve improved patient outcomes and healthcare cost savings. Given our findings, we believe that significant healthcare cost savings can be achieved by improving on the current standard of care for C-section deliveries in fetal head impaction. While our estimates capture direct hospital costs for associated complications, we have not yet estimated the additional associated costs of morbidity and decreased quality of life.