CenteringPregnancy Oral Health Promotion (CPOP)

University of California San Francisco (UCSF)

Status

Withdrawn

Conditions

Oral Health

Treatments

Other: CPOP Intervention

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04001933

1U01DE027340-01 (U.S. NIH Grant/Contract)

18-029-E

Details and patient eligibility

About

A five-year, Phase III, multi-site, cluster randomized controlled clinical trial will evaluate the efficacy of the CenteringPregnancy (CP) Oral Health Promotion (CPOP) intervention. Intervention and control groups will be drawn from 6 CP sites. Prenatal care facilitators will conduct the intervention in group prenatal care sessions. With an average of 4 CP facilitators per site (24 facilitators), conducting 2-3 CP groups each (48-72 CP groups with 8 mother/child dyads per group), the total study population will be approximately 384 dyads. CP facilitators will be randomly assigned to either the: 1) intervention arm and deliver the CPOP intervention; or 2) control arm and deliver the usual CP curriculum. The CPOP intervention consists of two 15-minute modules: 1) maternal oral health (OH) and 2) infant OH. The data collection will continue through 12 months postpartum. For the maternal OH module, pre- and post-intervention dental exams of gingival OH and Plaque Levels, and knowledge, attitudes and behavior (KAB) questionnaires during the prenatal period will be used to assess maternal OH outcomes. For the infant OH module, pre and post-module KAB questionnaires will be completed during the prenatal period. Infant OH risk status - the presence of caries-causing bacteria (mutans streptococci and Lactobacilli) in saliva of both mother and infant will be assessed when the infant is 12 months of age to determine differences in study arms.

Sex

Female

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Women:

speak, read, or write in English or Spanish
enrolled in CP prenatal group care identified as study group
free of any condition that requires them to take antibiotic or antibacterial medication prior to dental procedures
provide informed consent

Babies:

healthy with no acute or chronic medical conditions, especially those conditions that may have resulted in hospitalizations and subsequent exposure to pathologic microorganisms
free of any condition requiring antibiotic treatment currently or within the past three months.
mothers provide informed consent for their children at baseline

Exclusion criteria