At a glance
ClinicalIndex Comparison RecordN/ACompleted· 10,069 enrolled
Drug / intervention
Xylitol gumdietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Saving Lives at Birth: Primary Prevention of Periodontal Disease in Relation to Preterm Birth in Malawi (Prevention of Prematurity and Xylitol)
In Brief
A clinical study evaluating Xylitol gum for Preterm Birth and 2 related conditions. Completed, enrolled 10,069 participants across 1 site.
Detailed Summary
The hypothesis of the investigators' project is that comprehensive primary preterm birth prevention, inclusive of maternal oral health with xylitol chewing gum (the intervention), will reduce the rate of periodontal disease and caries, preterm birth prevalence, and neonatal mortality.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPreterm Birth, Periodontal Disease, Caries, Dental
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 2015
Enrollment StartMay 2015
Primary CompletionOct 2021
Study CompletionDec 2021
TodayJul 2026
First PostedJan 7, 2015
Enrollment StartMay 1, 2015
Primary CompletionOct 31, 2021
Study CompletionDec 1, 2021
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 11.5 years ago
Interventions
Xylitol gumdietary
This is a cluster randomized trial, whereby 4 sites will receive the intervention of xylitol gum in the prepregnancy and early pregnancy interval.