Formation of a National Perinatal Nitrous Oxide Data Registry: The Intrapartum Nitrous Oxide Workgroup I-NOW

Abstract

Background: There are a variety of labor analgesic options for parturients, such as intravenous opioids, neuraxial interventions, hydrotherapy, hypnosis, as well as inhaled nitrous oxide (N2O). Inhaled N2O has been utilized outside of the United States (U.S.) for decades but has only recently gained popularity in the U.S. as a labor analgesic. There are no current multi-center data registries evaluating N2O use as a labor analgesic regarding conversion rates, side effects, and delivery outcomes. Methods: We created the first multi-center N2O data registry to gather maternal and newborn outcome data from several institutions across the U.S. All centers were required to sign a Memorandum of Understanding (MOU) which stated that at least 80% of all parturients utilizing N2O for labor would be included in the database. We hypothesized that the data would assist in counseling and consenting parturients regarding incidence of side effects, conversion rates and etiologies, as well as neonatal outcomes. This manuscript demonstrates the steps taken to create the data registry, including institutional enrollment, development of a data collection tool, selection of the data management system and administrator, organization of multiple institutional review boards, delineation of responsibilities and challenges encountered with implementation. Conclusion: The development of a multi-center data registry was successfully created as we saw a need for a safe data-sharing system to answer mutually determined research questions, and to collect strong data information in order to provide evidenced based data to patients and providers.

Keywords

• multi-center
• nitrous oxide
• labor analgesia
• redcap®
• data registry