New PCORI – AMOR-IPAT Grant Proposal
On May 6th, three medical centers (the Hershey Medical Center [Hershey, Pa], Pinnacle Health [Harrisburg, Pa] and Wright State University [Dayton, Pa]) submitted a grant application to the Patient Centered Outcomes Research Institute (PCORI). Titled “A Three-institution Randomized Clinical Trial of the Active Management of Risk in Pregnancy at Term,” the grant proposes to investigate the use of AMOR-IPAT in a 3-year, multi-site, Randomized Clinical Trial (RCT). If approved, the project will begin in December of 2014 or January 2015. The goal of the proposed project is to see if risk-based “non-indicated” (i.e. “proactive”) labor induction, as compared to expectant management, might decrease the frequency and severity of maternal and neonatal childbirth complications (see Table 1 – a short list).
Table 1. Childbirth Complications: Maternal and Neonatal
The new method of care involves the use of common pregnancy risk factors to estimate, for each patient, the optimal time of delivery. If a pregnant woman has not developed spontaneous labor by the end of this optimal time, then she is offered labor induction (she is not required to be induced, but she will be induced if she desires or agrees to be induced). Hence, the study will investigate whether more frequent use of risk-based labor induction is beneficial or harmful. All previous studies of AMOR-IPAT have suggested that the more frequent use of risk-based “non-indicated” labor induction is beneficial (see Table 2). However, despite this evidence, most people believe that the use of labor induction increases the risk of adverse birth outcomes. If approved, the proposed study should help to determine the impact of the increased use of proactive labor induction on term childbirth outcomes. The study will involve 600 pregnancies over 3 years. The requested budget for the study is 2 million dollars.
As noted on its website, “The Patient-Centered Outcomes Research Institute (PCORI) is authorized by Congress to conduct research to provide information about the best available evidence to help patients and their health care providers make more informed decisions. PCORI’s research is intended to give patients a better understanding of the prevention, treatment and care options available, and the science that supports those options.”