Centering Pregnancy Oral Health Promotion (CPOP) Clinical Trial Planning Grant

University Of California, San Francisco, San Francisco CA

Investigators

Linked publications & trials

Abstract

? DESCRIPTION (provided by applicant): Federal agencies and professional organizations have mounted a large effort to address an increasingly recognized public health problem - poor perinatal oral health - which has serious implications for maternal and child health and is largely preventable. Several national organizations have issued statements prioritizing the need to improve oral health and access to oral health care during pregnancy and the National Maternal and Child Health Bureau has released consensus statements and clinical guidelines on perinatal oral health care during pregnancy. The provision of the recommended oral health care during pregnancy has the potential to improve women's oral health through improved prevention and restorative care and to promote children's oral health through caregiver education and timely anticipatory guidance. Through funding from the NIDCR (Adams, PI), we developed and pilot tested the CenteringPregnancy Oral Health Promotion (CPOP) Intervention, an oral health intervention for pregnant women attending CenteringPregnancy(r) (CP), a group prenatal care program. The CPOP intervention consists of 2 modules (maternal and infant) that are integrated into the CP(r) curriculum. The women completed dental examinations and questionnaires assessing OH knowledge, attitudes, and behaviors at pre- and post- intervention periods. Further NIDCR funding provided the opportunity to follow up the CPOP women and infants (CPOP-Extension - CPOPE, Chung, PI) to further evaluate outcomes particularly, infant and maternal salivary bacterial levels when the infants were 6 and 12 months of age. Findings from the CPOP and CPOPE follow-up studies show significant improvements in maternal and infant clinically-assessed oral health. The purpose of this R34 proposal is to develop our study team, finalize CPOP protocols and the analysis plan, and prepare the templates and monitoring systems and documents needed to manage and monitor a U01 clinical trial of CPOP. If shown to be efficacious in a RCT, CPOP could be implemented rapidly and broadly nationwide. Specifically, our aims are the following: Specific Aim 1: Finalize establishing the study team of academic researchers, CP(r) collaborators and community partners, research support staff, and their respective roles and responsibilities. Specific Aim 2a: Finalize study design, intervention, assessments, and training protocol; and plans for data collection, recruitment and retention, fidelity monitoring, and statistical analysis; and detailed timeline for the U01 clinical trial. Specific Aim 2b: Finalize plans for data management, quality assurance, quality control, and appropriate and effective safety and operational oversight and monitoring of the U01 trial. Specific Aim 3: Develop an NIDCR clinical protocol, Manual of Procedures, and associated documents including consent forms, IRB protocol(s), and proposed budget for the U01 trial.