Feasibility and Acceptability of Use of Daily Oral Rinse in Pregnant Women in Rural Nepal

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02788786
• Date of registration: 24/05/2016
• Prospective Registration: Yes
• Primary sponsor: Johns Hopkins Bloomberg School of Public Health
• Public title: Feasibility and Acceptability of Use of Daily Oral Rinse in Pregnant Women in Rural Nepal
• Scientific title: Feasibility and Acceptability of Daily Oral Rinse in Pregnant Women and Impact on Oral Inflammatory Biomarkers in Rural Nepal
• Date of first enrolment: June 27, 2016
• Target sample size: 175
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02788786
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Nepal

Contacts

• Name: Luke C Mullany, PhD
• Affiliation: Johns Hopkins University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Pregnant

- <26 weeks gestation at enrollment

- Enrolled in the broader cohort study

Exclusion Criteria:

- Already previously enrolled

- Not Pregnant



Age minimum: 15 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Periodontitis

Premature Birth of Newborn

Intervention(s)

Drug: Salt and Water

Drug: Cetylpyridinium chloride

Drug: Chlorhexidine

Primary Outcome(s)

Acceptability [Time Frame: 12 weeks]

Inflammatory markers in gingival crevicular fluid (IL-1ß, IL-6, IL-10, TNF-a, PGE2, and GM-CSF) [Time Frame: 12 weeks]

Secondary ID(s)

OPP1131701

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bill and Melinda Gates Foundation