Preterm Birth Clinical Trial
Official title:
Effect of Supplementation of Fluoride on Maternal Periodontal Health, Preterm Delivery, and Perinatal Well-Being
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.
The Centers for Disease Control and Prevention (CDC) reports that preterm birth affected
about 1 in 10 infants born in the United States in 2015. These statistics emphasize the
significance of implementing a safe and effective therapy into routine clinical care aimed at
reducing the rate of preterm birth. There has been evidence to suggest that fluoride
supplementation to women during pregnancy can provide other medical benefits, in addition to
a reduction in dental caries.
Fluoride is recognized by the Food and Nutrition Board (F&NB) of the American Academy of
Sciences and the Food & Drug Administration (FDA) as an essential ion due to its association
with a reduction in dental caries.
Upon entering the body, fluoride is taken up into the bones/calcified tissues, and excreted
by the kidneys. When supplied during pregnancy in small aliquots, as with water fluoridation,
the fluoride is likely taken up in the mother's bones and excreted by her kidneys so rapidly,
that the fetus is denied a meaningful amount of fluoride, unless it is supplied in a pulse
dose by supplement. The Institute of Medicine's Food and Nutrition Board recommends 3 mg/day
for Adequate Intake in pregnancy and deems 10 mg/day as the Upper Limit.
After several papers elucidating an association between poor dentition, periodontal disease,
and preterm birth, subsequent RCT's of regular periodontal scaling and treatment during
pregnancy are still inconclusive in regards to preterm birth.
The investigators hypothesize that fluoride supplementation during pregnancy may have a
beneficial effect on the natural microbiome of the maternal oral cavity and genital tract,
capable of protecting against transient bacteremia and ascending infection, respectively,
which are known antecedents to both preterm labor and preterm premature rupture of membranes.
The research team predicts that the testing and analysis of specimens collected will
demonstrate microbiome changes toward a more favorable profile not associated with preterm
birth.
The proposed randomized, double-blinded, placebo-controlled clinical trial aims to confirm
the efficacy of fluoride supplementation in pregnancy to extend length of gestation and
increase overall perinatal well-being, and to confirm transplacental transfer of supplemental
fluoride. This research may also identify other beneficial maternal and neonatal outcomes
associated with the administration of fluoride during the perinatal period by attempting to
characterize and compare the microbiomes of the maternal oral cavity and genital tracts
between supplemented and unsupplemented gravidas.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
| Completed |
NCT05502510 -
Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
|
||
| Not yet recruiting |
NCT03418311 -
Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome
|
N/A | |
| Not yet recruiting |
NCT03418012 -
Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB
|
N/A | |
| Completed |
NCT02993744 -
Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone
|
N/A | |
| Active, not recruiting |
NCT02673216 -
Infection and Adverse Pregnancy Outcome
|
||
| Completed |
NCT01683565 -
Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
|
Phase 4 | |
| Completed |
NCT01460576 -
Improving Prematurity-Related Respiratory Outcomes at Vanderbilt
|
N/A | |
| Completed |
NCT01412931 -
Protein and Ultrasound Indicators of Preterm Birth
|
N/A | |
| Completed |
NCT02606058 -
The Australian Placental Transfusion Study (APTS): Should Very Pre Term Babies Receive a Placental Blood Transfusion at Birth Via Deferring Cord Clamping Versus Standard Cord Clamping Procedures?
|
N/A | |
| Terminated |
NCT03715530 -
Use of Placental Alpha Microglobulin-1(PAMG-1) to Diagnose Premature Rupture of Membranes in Pregnant Women
|
N/A | |
| Completed |
NCT00422526 -
Progesterone for Prevention of Preterm Birth in Women With Short Cervix: Randomized Controlled Trial
|
Phase 3 | |
| Enrolling by invitation |
NCT04251260 -
Effectiveness of Positioning in Preterm Neonates
|
N/A | |
| Completed |
NCT03668860 -
India Dexamethasone and Betamethasone
|
Phase 1 | |
| Recruiting |
NCT03638037 -
Correlation Between Maternal Vitamin D Level And Preterm Birth
|
||
| Completed |
NCT02225353 -
Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery
|
Phase 2 | |
| Recruiting |
NCT03992534 -
The FLIP-1 Study: Vaginal Lactobacillus Supplementation in Women at High Risk of Preterm Birth
|
Phase 1 | |
| Completed |
NCT03144141 -
Association Between EHG and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery
|
N/A | |
| Completed |
NCT05210985 -
Examination of the Relationship Between Home Affordances With Development
|
||
| Completed |
NCT04021654 -
What is the Future of Vulnerable New-borns
|