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Chewing gum to prevent premature births? major trial underway in malawi

NCT ID NCT07424846

Prevention Sponsor: University of Washington Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 11, 2026 · Updated 6 times

Summary

This study tests whether chewing xylitol gum during pregnancy can reduce the risk of preterm birth and low birthweight. 6,000 pregnant women in Malawi will chew either a high or low dose of xylitol gum or a placebo gum. The goal is to see if improving oral health with xylitol leads to healthier pregnancies and better outcomes for babies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Xylitol chewing gum
What this could lead to
If it works, this could provide a simple, low-cost way to reduce preterm birth and improve infant health in high-risk populations.
What could go wrong
This is a Phase 2/3 trial building on earlier unblinded results. The effect may be smaller than hoped, and results may not apply to other populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 6,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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 inclusion criteria will be approached without regard to sex, race, ethnicity, parents' country of origin, or religious preferences. Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

gingivitis learning disability periodontal disorder periodontitis Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Developmental delay Gingivitis Low birthweight neonate Periodontitis Preterm birth

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baylor College of Medicine Children's Foundation Malawi

    RECRUITING

    Lilongwe, Malawi

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