Preterm BirthPPaXNCT02333227
Saving Lives at Birth: Primary Prevention of Periodontal Disease in Relation to Preterm Birth in Malawi
A study testing Xylitol gum in people with Preterm Birth and Periodontal Disease, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Periodontal Disease, Caries, Dental
- What is being tested?
- Xylitol gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,069 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2015to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Enrollment at <20 weeks gestation by best obstetrical estimate, or
- Enrollment post partum with an anticipated next pregnancy within 18 months, or
- Enrollment preconception with an anticipated pregnancy within 18 months (preconception); and
- Cognitively aware enough to participate in the study
- >18 years of age (in Malawi, constitutes a legal adult and capacity to consent for study)
- Willing to participate in the study
Show all 9Show fewer
- Willing to undergo at least two periodontal exams
- Willing to chew 1 piece of xylitol gum for 10 minutes after the morning and evening meal (intervention sites)
- Anticipating to remain within the region for 18 months
Who cannot join
- >20 weeks gestation by best obstetrical estimate
- Post partum and not anticipating another pregnancy within 18 months
- Preconception and not anticipating another pregnancy within 18 months
- Not cognitively aware enough to participate in the study
- Not willing to undergo at least two periodontal exams
- <18 years of age
- Not willing to chew 1 piece of xylitol gum for 10 minutes after the morning and evening meal (intervention sites)
- Anticipating a move outside of the region within 18 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Saving Lives at Birth: Primary Prevention of Periodontal Disease in Relation to Preterm Birth in Malawi (Prevention of Prematurity and Xylitol)
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.
Read the detailed description
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.
- Conditions
- Preterm Birth, Periodontal Disease, Caries, Dental
- Being tested
- Xylitol gum
- Medical subject headings
- Premature Birth, Periodontal Diseases, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xylitol gumDietary supplement
This is a cluster randomized trial, whereby 4 sites will receive the intervention of xylitol gum in the prepregnancy and early pregnancy interval.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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. |
| Xylitol | Experimental | Cluster of sites receiving xylitol gum. Receives: Dietary Supplement: Xylitol gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Date of delivery to 1 week postnatal
Secondary outcomes (3)
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)
Measured: 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.
Measured: 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.
Measured: During pregnancy, up to 2 dental visits performed during pregnancy (approximately 37-40 weeks if term) to evaluate dental outcomes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study start1 May 2015
- Primary completion31 Oct 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10,069 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kjersti Aagaard, Baylor College of Medicine
- Investigators
- Kjersti Aagaard, M.D., Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333227
- Sponsor's protocol ID
- NHSRC # 1030
- Other IDs
- H-35933
- Acronym
- PPaX
- Status last verified
- Mar 2023
- First submitted
- 23 Dec 2014
- Last updated
- 8 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saving Lives at Birth: Primary Prevention of Periodontal Disease in Relation to Preterm Birth in Malawi (Prevention of Prematurity and Xylitol)
- ClinicalTrials.gov ID
- NCT02333227
- Acronym / sponsor ID
- PPaX / NHSRC # 1030
- Conditions
- Preterm Birth, Periodontal Disease, Caries, Dental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,069 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 7 Jan 2015 (estimated)
- Results
- Posted 8 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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. |
| Xylitol | Experimental | Dietary Supplement: Xylitol gumCluster of sites receiving xylitol gum. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Enrollment at <20 weeks gestation by best obstetrical estimate, or
- Enrollment post partum with an anticipated next pregnancy within 18 months, or
- Enrollment preconception with an anticipated pregnancy within 18 months (preconception); and
- Cognitively aware enough to participate in the study
- >18 years of age (in Malawi, constitutes a legal adult and capacity to consent for study)
Key exclusion criteria (8 listed)
- >20 weeks gestation by best obstetrical estimate
- Post partum and not anticipating another pregnancy within 18 months
- Preconception and not anticipating another pregnancy within 18 months
- Not cognitively aware enough to participate in the study
- Not willing to undergo at least two periodontal exams
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xylitol gumThis is a cluster randomized trial, whereby 4 sites will receive the intervention of xylitol gum in the prepregnancy and early pregnancy interval. | Dietary supplement | Xylitol |
Primary outcome
Rate of Preterm Birth
Time frame: Conception to date of delivery, <37 weeks gestation
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.
Number of Infants <2500 Grams
Time frame: Date of delivery to 1 week postnatal
This is a co-primary outcome: Measured weight at delivery to determine the rate of <2500 gram infants.
3 secondary outcomes
Number of Infants With Adverse Neonatal Composite Morbidity and Mortality
Time frame: Date of delivery to 28 days postnatal
Number of Participants With Periodontal Disease
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
Time frame: During pregnancy, up to 2 dental visits performed during pregnancy (approximately 37-40 weeks if term) to evaluate dental outcomes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kjersti Aagaard, M.D. principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xylitol gum in people with Preterm Birth and Periodontal Disease, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Preterm Birth (time frame: Conception to date of delivery, <37 weeks gestation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.