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Prevention study for Preterm Birth
Official title Xylitol and the Prevention of Periodontal Disease and Preterm Birth Trial
ClinicalTrials.gov ID: NCT07424846
What this study is testing
What is Xylitol Chewing gum?
Xylitol Chewing gum is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for preterm birth.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The ground-breaking Prevention of Prematurity and Xylitol (PPaX) cluster randomized controlled clinical trial was conducted in Lilongwe, Malawi and enrolled approximately 10,069 pregnant individuals seeking to evaluate the impact of xylitol-containing chewing gum compared to no chewing gum on reducing the occurrence of maternal periodontal disease, preterm birth, and low birthweight offspring. The premise of this study centers upon the numerous publications supporting a strong association between maternal periodontal disease and preterm birth.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults, women only
You may be able to join if
- Able to provide informed consent. For those under 18 years of age, an approval will additionally be sought from the parent or guardian
- Less than 20 weeks' gestation (by best obstetric estimate)
- At least 20 natural teeth
- Planning to deliver at one of the health facilities within the XaPPP trial
- Receiving antenatal obstetric care at one of the 8 health districts
You likely can't join if
- Those who upon screening and enrolment but dislike the taste of the gum and state they will not chew the gum throughout pregnancy
- Gravidae with known or suspected non-viable pregnancy (including life threatening congenital anomalies such as cardiac, neurological or others)
- Pregnant individual has a life-threatening diagnosis such as cancer requiring treatment during pregnancy
- Pregnant women with a known or suspected morbidly adherent placenta (such as placenta accrete, increta and percreta)
- Known allergy to xylitol
See the full eligibility criteria
- Able to provide informed consent. For those under 18 years of age, an approval will additionally be sought from the parent or guardian
- Less than 20 weeks' gestation (by best obstetric estimate)
- At least 20 natural teeth
- Planning to deliver at one of the health facilities within the XaPPP trial
- Receiving antenatal obstetric care at one of the 8 health districts
- Willing to chew two pieces of gum thrice daily for 5 minutes after the morning, day and evening meals throughout pregnancy
- Willing to attend all study visits
- Willing to provide biospecimens (oral, vaginal, placental, breast milk)
- Willing to undergo at least two dental exams including oral microbiota sampling at study enrolment \<20 weeks of pregnancy, 28-30 weeks of pregnancy, and 6-8 weeks after giving birth
- Willing to have their child undergo follow up through at least 12 months after birth including neurodevelopmental examination(s)
- Speaks Chichewa or English All patients who meet will be approached without regard to sex, race, ethnicity, parents' country of origin, or religious preferences.
- Those who upon screening and enrolment but dislike the taste of the gum and state they will not chew the gum throughout pregnancy
- Gravidae with known or suspected non-viable pregnancy (including life threatening congenital anomalies such as cardiac, neurological or others)
- Pregnant individual has a life-threatening diagnosis such as cancer requiring treatment during pregnancy
- Pregnant women with a known or suspected morbidly adherent placenta (such as placenta accrete, increta and percreta)
- Known allergy to xylitol
The study team makes the final eligibility decision.
Where it's taking place
- Lilongwe, Malawi
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lilongwe, Malawi. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.