CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 43 enrolled
Drug / intervention
Prenatal vitamin-mineral containing 3 mg fluoride +1 moredrug
Likely dose
Prenatal vitamin-mineral containing 3 mg fluoridefrom 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.

Search/NCT02536352
NCT02536352Early Ph 1Completed
CompareCT.gov

Effect of Supplementation of Fluoride on Maternal Periodontal Health, Preterm Delivery, and Perinatal Well-Being

Johns Hopkins University·interventional·Posted Aug 31, 2015·Updated Nov 5, 2019

In Brief

A Early Phase 1 clinical trial evaluating Prenatal vitamin-mineral containing 3 mg fluoride and Prenatal vitamin-mineral containing 0 mg fluoride for Preterm Birth and 3 related conditions. Completed, enrolled 43 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether fluoride supplementation during pregnancy is effective in extending the length of gestation and improving overall perinatal well-being.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPreterm Birth, Preterm Labor, Bacteremia, Preterm Premature Rupture of Fetal Membranes
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 31, 2015
Enrollment StartOct 1, 2015
Primary CompletionOct 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 10.8 years ago

Interventions

Prenatal vitamin-mineral containing 3 mg fluoridedrug

Prenatal vitamin-mineral containing 3 mg fluoride to be taken daily, starting at 10-20 weeks gestation until delivery.

Prenatal vitamin-mineral containing 0 mg fluoridedietary

Prenatal vitamin-mineral containing 0 mg fluoride to be taken daily, starting at 10-20 weeks gestation until delivery.