PCORI Grant Proposal

Proposed Patient-Centered Outcomes Research Institute (PCORI) Study

In May of this year, AMOR-IPAT submitted a grant proposal for PCORI funding for a 3-year, multi-site, Randomized Clinical Trial (RCT) involving the use of AMOR-IPAT methodology. If approved, the project will begin in January 2015. The goal of this proposed project is to study a new method of term pregnancy management that might decrease the frequency and severity of maternal and neonatal childbirth complications (see Table 1 – a short list).

Childbirth Complications: Maternal and Neonatal

Table 1. Childbirth Complications: Maternal and Neonatal

  • Maternal Death (rare)
  • Neonatal Death (>1:1000)
  • Maternal ICU Admission (rare)
  • Neonatal ICU Admission (1:10)
  • Cesarean Delivery (1:3)
  • Major Perineal Injury (1:20)
  • Excessive Blood Loss [Hemorrhage] (1:50)
  • Severe Maternal Hypertension (Pre-Eclampsia)

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 only 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 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 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.

AMOR-IPAT vs. Current Standard of Care


PCORI: Patient-Centered Outcomes Research Institute


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."


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