Saving Lives at Birth: Primary Prevention of Periodontal Disease in Relation to Preterm Birth in Malawi (PPaX)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02333227|
Recruitment Status : Recruiting
First Posted : January 7, 2015
Last Update Posted : August 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Preterm Birth Periodontal Disease Caries, Dental||Dietary Supplement: Xylitol gum||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||9365 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Saving Lives at Birth: Primary Prevention of Periodontal Disease in Relation to Preterm Birth in Malawi (Prevention of Prematurity and Xylitol)|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||January 2020|
No Intervention: Control
Cluster of sites not receiving xylitol gum. This is a cluster randomized trial, whereby 4 sites will not receive the intervention of xylitol gum in the prepregnancy and early pregnancy interval.
Cluster of sites receiving xylitol gum.
Dietary Supplement: Xylitol gum
This is a cluster randomized trial, whereby 4 sites will receive the intervention of xylitol gum in the prepregnancy and early pregnancy interval.
- Rate of preterm birth [ Time Frame: Conception to date of delivery, <37 weeks gestation ]Measure rate of preterm birth <37 and <34 weeks gestation, as defined by best obstetrical estimate of last menstrual period consistent with <24 week sonogram, OR <24 week sonogram with unknown last menstrual period, OR skilled examination and <24 week sonogram.
- Number of infants <2000 grams [ Time Frame: Date of delivery to 1 week postnatal ]Measured weight at delivery to determine the rate of <2000 gram infants.
- Number of infants with adverse neonatal composite morbidity and mortality [ Time Frame: Date of delivery to 30 days postnatal ]Additive or singular composite neonatal morbidity of <2000 gram infants at 30 days of age. Composite neonatal morbidity and mortality outcomes are defined as: neonatal death, neonatal sepsis, neonatal respiratory distress requiring assisted ventilation (generally bubble CPAP in this region of Malawi), exogenous oxygen, necrotizing enterocolitis, and neonatal seizures.
- Prevalence of periodontal disease [ Time Frame: Enrollment up to 5 years ]We will measure the prevalence of periodontal disease among gravidae. We will use now standardized WHO oral health forms and disease scoring.
- Prevalence of dental caries [ Time Frame: Enrollment up to 5 years ]We will measure the prevalence of dental caries among gravidae. We will use now standardized WHO oral health forms and disease scoring.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02333227
|Contact: Kjersti Aagaard, M.D.||713 email@example.com|
|United States, Texas|
|Baylor College of Medicine||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Kjersti Aagaard, MD/PhD 713-798-8467 firstname.lastname@example.org|
|Contact: Brigid Boggan, BS 713-798-8701 email@example.com|
|Sub-Investigator: Brigid D Boggan, BS|
|Principal Investigator: Kjersti Aagaard, MD/PhD|
|Sub-Investigator: Kathleen Antony, MD|
|Sub-Investigator: Raine Susan, MD|
|Principal Investigator:||Kjersti Aagaard, M.D.||Baylor College of Medicine|