A standardized labor induction protocol to reduce primary cesarean and racial disparities in labor outcomes: a prospective cohort study

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PROJECT SUMMARY Nearly 1 in 3 deliveries in the United States occurs by cesarean section, with unacceptable racial disparities impacting that rate. Protocols to standardize care have been shown to decrease adverse outcomes across medicine, including in obstetrics. In addition to improving outcomes overall, studies in non-obstetric populations have demonstrated that care standardization can considerably reduce racial disparities in health by reducing care variation, thereby minimizing the effects unconscious bias can have on decision-making. Labor induction, one of the most common procedures in obstetrics, varies widely in practice patterns by provider and site. Thus, we propose a novel means of reducing the cesarean rate, as well as racial disparities in obstetric outcomes: standardization of labor induction. The central hypothesis of this proposal is that a labor induction protocol will standardize the use of evidence-based active labor management practices in induction, thereby improving outcomes such as cesarean delivery rate, maternal morbidity, and neonatal morbidity. In addition, we believe our intervention will inhibit implicit bias from playing a significant role in labor management, thus specifically decreasing morbidity for Black women. This proposal will leverage mentorship of senior investigators (Drs. Parry and Levine) and Penn’s research programs in maternal fetal medicine, implementation science, biostatistics/epidemiology, and qualitative methods. We plan to test our hypothesis by studying the effectiveness of a standardized labor induction protocol, while simultaneously collecting process implementation data in a prospective cohort design. Aim 1 will compare obstetric outcomes two years pre- to two-years post-implementation of the labor induction protocol into routine care at two diverse sites. Aim 1A will determine if the induction protocol reduces racial disparities in these critical obstetric outcomes. Aim 2 will utilize the innovative mixed-methodologies of implementation science, underused to date in obstetrics, to understand acceptability, penetration, and fidelity surrounding the induction protocol. These data will aid in preparing our intervention for implementation in the national arena. Evaluation of the use of standardized labor induction protocol to reduce cesarean rate and eliminate racial disparities is a significantly important clinical question yet to be studied in the literature. Dr. Hamm is a maternal fetal medicine physician trained in clinical epidemiology with an established interest in implementation research. The training she proposes in designing effectiveness trials, the methodologies of implementation science, and leadership in healthcare innovation will enable her to become an independent researcher studying the implementation of large-scale, evidence-based initiatives in obstetrics. By the conclusion of this program, she will be able to independently design, enact, and evaluate interventions to reduce obstetric morbidity. The results of the proposed K23 will be invaluable pilot work for a planned R01-level application.