Daniel B Walk, Elizabeth Carstens, Anupama Atluru, Sandeep Ganji, PhD, Adam Harris, Scott Roberts, MD, Michael Choti, MD, MBA, FACS. The University of Texas Southwestern Medical Center
Objective of the technology or device:
Cesarean section delivery (C-section) is now performed in about a third of births in the United States. One of the serious complications encountered during this procedure is called an impacted fetal head. This life threatening event occurs when the baby’s head does not fit through the birth canal and the mother’s contractions force the baby’s head deep into the pelvis, where it becomes stuck during a prolonged second stage (pushing phase) of labor. The baby’s head cannot advance and it is difficult to pull or push back into the uterus for a cesarean delivery. Obstetricians 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. Impacted fetal head is associated with adverse maternal and fetal outcomes including increased risk of intracranial hemorrhage, lower APGAR scores, maternal hemorrhage, thromboembolism, and infection, as well as added psychological and financial burden for some families. Globally, it is estimated by the World Health Organization that up to 8% of annual maternal deaths are attributable to prolonged second stage of labor, a proxy for this impaction.
We hypothesize that the maternal and fetal morbidity associated with the current manual disimpaction maneuvers are due to high pressures exerted on the maternal and fetal tissues as well as a prolonged extraction time. These high pressures are generated by the significant force being applied over the small surface area of obstetricians’ fingertips. We further hypothesize that a means to decrease these high pressures and reduce the extraction time would decrease this mortality and morbidity. Thus, we developed a device, the “Safe-C Pump” to allow for low-pressure, rapid extraction.
Description of the technology and method of its use or application.
The Safe-C Pump is deployed into the birth canal by an obstetrician or birth attendant during prolonged second stage labor. The device provides a controlled, uniform disimpaction force over a large maternal/fetal contact area, allowing for a rapid, low-pressure disimpaction. Furthermore, the device has a straightforward operation, allowing lower level providers to accomplish the equivalent of complex delivery maneuvers.
Preliminary results if available.
Testing the device on the AR58 “Desperate Debra” Fetal Head Impaction Simulator in the hands of experienced obstetricians, the Safe-C Pump is able to disimpact the fetal head significantly faster than manual extraction alone. The device also accomplished successful deliveries of impactions too difficult to perform manually in this simulator. In addition, differences in delivery outcomes observed between inexperienced and experienced users during manual extraction were reduced when using the device.
Conclusions / future directions.
The Safe-C Pump demonstrates significant potential advantages over the current standard of care for emergency cesarean sections in the U.S. Furthermore, the device offers great promise in developing world environments in which the rate of emergency C-sections are high and experienced obstetricians are limited. Future steps include completion of a cost-benefit analysis, acquisition of funding for further device development, and initiation of human testing.