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CenteringPregnancy Oral Health Promotion (CPOP) Clinical Trial

Centering妊娠期口腔健康促进（CPOP）临床试验

基本信息

批准号：
9762887
负责人：
SALLY Henderson ADAMS
金额：
$ 123.04万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-08-13 至 2023-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9762887
关键词：
Address Age-Months American College of Obstetricians and Gynecologists Attitude Attitude to Health Award Awareness Bacteria Behavior Behavioral California Caring Child Child Health Clinical Clinical Trials Communities Consensus Counseling Dental Dental Care Dental Hygiene Dental caries Development Educational Curriculum Fostering Funding Goals Grant Guidelines Health Health Knowledge, Attitudes, Practice Health Professional Health Promotion Health education Healthcare Hemorrhage Hygiene Incidence Infant Instruction Intervention Lactobacillus Leadership Letters Low income Maintenance Maternal and Child Health Mediating Modeling Mothers National Institute of Dental and Craniofacial Research Oral health Outcome Perinatal Phase Pilot Projects Postpartum Period Pregnancy Pregnant Women Prenatal care Preparation Prevention Preventive Professional Organizations Public Health Questionnaires Randomized Controlled Clinical Trials Randomized Controlled Trials Recommendation Research Risk Safety Salivary Site Strategic Planning Streptococcus mutans Testing Time Training Woman Women&apos s Group Women&apos s Health base care providers caregiver education clinically significant community building cost early childhood efficacy testing empowerment ethnic minority population evidence base experience hands-on learning health disparity health knowledge improved indexing oral streptococci post intervention prenatal prenatal health prevent programs racial and ethnic skills standard of care theories treatment arm treatment as usual uptake

项目摘要

Abstract 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 (R21DE019211 Adams, PI; U54 DE019285 Chung, PI), we developed and pilot tested the CenteringPregnancy Oral Health Promotion (“CPOP”) Intervention, an oral health intervention for pregnant women attending CenteringPregnancy® (CP), a group prenatal care program. The CPOP intervention consists of 2 educational and skills building modules (maternal and infant) that are integrated into the CP curriculum, and delivered by trained CP facilitators. To evaluate the modules, the women completed dental examinations and questionnaires assessments of OH knowledge, attitudes, and behaviors at pre- and post- intervention periods. Infant and maternal salivary bacterial levels were assessed when the infants were 6 and 12 months of age. Findings from the CPOP pilot studies show significant improvements in maternal and infant clinically-assessed oral health. NIDCR funding (R34DE024574) has supported the development of the final planning and preparation for the U01 CPOP RCT. The purpose of this U01 proposal is to test the efficacy of the CPOP intervention as a full scale Phase III randomized controlled trial among a group of women receiving CP prenatal care at sites across Northern California. If shown to be efficacious, CPOP could be implemented rapidly and broadly nationwide.

摘要联邦机构和专业组织已经做出巨大努力，以解决日益严重的公认的公共卫生问题-围产期口腔健康状况不佳-对孕产妇和儿童健康，而且在很大程度上是可以预防的。一些国家组织发表声明，需要改善口腔健康和获得口腔保健在怀孕期间和国家孕产妇和儿童健康局就围产期口腔健康护理发表共识声明及临床指引孕期在怀孕期间提供推荐的口腔保健有可能通过改进预防和恢复性护理，改善妇女口腔健康，并促进儿童口腔健康，通过对护理人员的教育和及时的预见性指导来促进健康。通过NIDCR（R21 DE 019211亚当斯，PI; U 54 DE 019285 Chung，PI）的资助，我们开发并试点测试了CenteringPregnancy Oral Health Promotion（“CPOP”）Intervention，孕妇参加CenteringPregnancy®（CP），一个团体产前护理计划。CPOP 干预措施包括2个教育和技能建设模块（孕产妇和婴儿）， CP课程，并由训练有素的CP辅导员提供。为了评估这些模块，牙科检查和问卷评估OH的知识，态度和行为，在前和干预后时期。在婴儿6岁时评估婴儿和母亲唾液细菌水平和12个月大。CPOP试点研究的结果显示，孕产妇和婴儿临床评估的口腔健康。NIDCR资金（R34 DE 024574）支持了 U 01 CPOP RCT的最终计划和准备。本U 01提案的目的是测试CPOP干预作为全面III期的有效性一项在北方地区接受CP产前护理的妇女中进行的随机对照试验加州。如果证明是有效的，CPOP可以在全国范围内迅速广泛实施。