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.
Significance and Impact: Adverse birth outcomes related to the length of gestation (preterm birth) are recognized as one of the most significant disorders in maternal-child health at a global scale. In the developed world, the preterm birth rate approximates 7%. In Malawi, the investigators have recently demonstrated that this rate more than triples to approximate 26.1%. Of the 4 million newborn deaths annually, nearly 1/3 (27%) are directly attributable to prematurity with another 36% secondary to related opportunistic infections (sepsis, pneumonia, gastrointestinal). 75% of the 4 million deaths occur within the first week of life, with the vast majority occurring in the first 48 hours. For those that do survive, there are persistent and lifelong risks due to stunted growth, chronic infection, retinopathy of prematurity, and bronchopulmonary dysplasia. The link between maternal oral health (periodontal disease in particular) and risk of preterm birth has been demonstrated across all populations (rural and urban, in both industrialized and developing regions) studied to date. However, in multiple randomized controlled trials treatment of active periodontal disease with scaling and planning during pregnancy has failed to demonstrate a significant benefit in preventing preterm birth. Why would maternal oral health impact preterm birth? In rodents, subcutaneous inoculations with periodontal pathogens cause dose-dependent decreases in pup weights, and elicit inflammatory responses that can trigger preterm birth when present in amniotic fluid. Periodontitis (defined as a destructive inflammation of the periodontium) has a prevalence of 30% or greater in women of child bearing age. By definition, it involves microbial infiltration of the periodontium, which stimulates a chronic inflammatory response, recurrent bacteremia, and the production of cytokines and prostaglandins which trigger risk of preterm birth. It is the same production of prostaglandins which are felt to mediate the risk of preterm birth. So if the investigators know that there is biologic evidence that periodontitis is related to preterm birth, but treating active periodontitis does not reduce these morbidities, is it possible that preventing periodontitis might prevent preterm birth and low birth weight? If so, what are the least expensive efficacious preventative measures? The investigators' overarching hypothesis 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
10,069
This is a cluster randomized trial, whereby 4 sites will receive the intervention of xylitol gum in the prepregnancy and early pregnancy interval.
Baylor College of Medicine
Houston, Texas, United States
Rate of Preterm Birth
This is a co-primary outcome: Measure rate of preterm birth \<37 weeks gestation, as defined by best obstetrical estimate based upon last menstrual period correlated with fundal height at entry to prenatal care or ultrasound, when available; all sites have access to referral for ultrasound.
Time frame: Conception to date of delivery, <37 weeks gestation
Number of Infants <2500 Grams
This is a co-primary outcome: Measured weight at delivery to determine the rate of \<2500 gram infants.
Time frame: Date of delivery to 1 week postnatal
Number of Infants With Adverse Neonatal Composite Morbidity and Mortality
Additive or singular composite neonatal morbidity up to 28 days of age. Composite neonatal morbidity and mortality outcomes are defined as: neonatal death, miscarriage \<28 weeks, stillbirth (fresh or macerated), neonatal sepsis, neonatal respiratory distress, neonatal seizures, feeding problems, fever, hypothermia, Apgar score \<7 at 5 minutes after birth, referral to other hospital or neonatal intensive care unit (NICU)
Time frame: Date of delivery to 28 days postnatal
Number of Participants With Periodontal Disease
We will measure the prevalence of periodontal disease among gravidae. We will use standardized World Health Organization (WHO) oral health forms and disease scoring.
Time frame: During pregnancy, up to 2 dental visits performed during pregnancy (approximately 37-40 weeks if term) to evaluate dental outcomes
Number of Participants With Dental Caries
We will measure the prevalence of dental caries among gravidae. We will use standardized World Health Organization (WHO) oral health forms and disease scoring.
Time frame: During pregnancy, up to 2 dental visits performed during pregnancy (approximately 37-40 weeks if term) to evaluate dental outcomes
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