Preterm BirthPhase 2/3XaPPPNCT07424846
Xylitol and the Prevention of Periodontal Disease and Preterm Birth Trial
A Phase 2/3 study testing Xylitol Chewing gum and Sorbitol chewing gum in people with Preterm Birth and Low Birthweight Neonate, run by University of Washington at 1 site in Malawi.
Trial summary
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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Preterm Birth, Low Birthweight Neonate, Periodontitis
- What is being tested?
- Xylitol Chewing gum and Sorbitol chewing gum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6,000 participants
- Where
- 1 siteMalawi
- Study dates
- 26 Mar 2026to 30 Sep 2030
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malawi1 site, 1 recruiting
- Recruiting
Baylor College of Medicine Children's Foundation Malawi
Lilongwe
Joseph Mhango, +265 1 750 877, jmhango@baylorfoundationmalawi.org
About this study
Official title: Xylitol and the Prevention of Periodontal Disease and Preterm Birth (XaPPP) Trial
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. Given that xylitol-containing chewing gum is considered a prebiotic and known to reduce cariogenic and periodontopathic bacteria, the study evaluated and discovered a statistically significant reduction in maternal periodontal disease, preterm birth, and low birthweight offspring among pregnant individuals who chewed xylitol-containing chewing gum.
While PPaX demonstrated the efficacy of xylitol to reduce preterm birth (PTB), the study had important limitations: (a) PPaX was an unblinded cluster-randomized study with only 8 clusters, 4 with xylitol-containing chewing gum and 4 without any gum (not placebo-controlled); (b) PPaX used a suboptimal dose of 2 grams of xylitol daily which may have reduced the effectiveness of the intervention given that recent literature suggests 5-10 grams/day more effectively improve oral health; and (c) PPaX did not evaluate infant mortality nor early neurodevelopmental outcomes. Notably, reducing fetal exposure to periodontal disease (PD) as well as PTB may improve neurodevelopmental outcomes for offspring as both prematurity and fetal exposure to inflammation are well-documented risk factors for neurodevelopmental delay (NDD) and infant mortality.
The investigators will conduct a double-blind, placebo-controlled, individually randomized clinical trial with 3 arms among Malawian pregnant individuals (n=6000) at <20 weeks of pregnancy with the co-primary outcomes being the incidence of PTB and low birthweight offspring. The 3 study arms (n=2000 each) will be (a) an optimized dose of xylitol-containing chewing gum (6.4 grams/day), (b) the PPaX trial xylitol dose (2.1 grams/day), or (c) flavored sorbitol gum base (placebo control). This trial overcomes the PPaX trial's limitations and will definitively answer whether xylitol prevents PTB in Malawi. The investigators will additionally collect biospecimens from a random sampling of the participants for biobanking for later analysis of inflammatory and microbiome alterations that may occur with xylitol exposure compared with placebo. The investigators hypothesize that pregnant individuals who chew xylitol-containing chewing gum will have a significant reduction in periodontal disease metrics at 28-30 weeks' gestation (e.g. bleeding on probing) as well as offspring with improved neurodevelopmental outcomes as assessed by the Bayley Scales of Infant and Toddler Development 4th edition and reduced risk of adverse pregnancy outcomes including preterm birth.
Read the detailed description
The hypothesis is that xylitol-containing chewing gum use compared to control (flavored gum base) during pregnancy, starting before 20 weeks' gestation, will lead to reduced risk of adverse pregnancy outcomes, namely preterm birth, as well as improved metrics of periodontal disease and improve neurodevelopmental outcomes of offspring at 2 years corrected gestational age, with most beneficial effect seen in those with 6.4 grams/day xylitol dose.
The study will utilize an individually randomized, placebo-controlled, double-blinded, phase II/III clinical trial with a 1:1:1 allocation ratio between xylitol-containing chewing gum (6.4 grams of xylitol/day), xylitol-containing chewing gum (2.1 grams of xylitol/day), and placebo (flavored gum base, sorbitol, 0 grams of xylitol/day).
Intervention (1st arm): Epic dental chewing gum (xylitol-containing chewing gum containing 1.06 grams xylitol/pellet). Participants will chew 6 Epic xylitol-containing chewing gum pellets each day (2 pellets three times daily in pre-made blister packs). Each participant will be instructed to chew 2 pieces of gum three times daily for 5 minutes each time starting at study entry (<20 weeks' gestation) and continuing until delivery.
Intervention (2nd arm): Epic dental chewing gum (xylitol-containing chewing gum containing 1.06 grams xylitol/pellet). Participants will chew 2 Epic xylitol-containing chewing gum pellets and 4 placebo gum pellets per day, representing 2 pellets three times daily in pre-made blister packs. Each participant will be instructed to chew 2 pieces of gum three times daily for 5 minutes each time starting at study entry (<20 weeks' gestation) and continuing until delivery.
Control: Flavored gum base (sorbitol) without xylitol, instructing the participants to chew 2 pieces of gum three times daily for 5 minutes each time, the same as the intervention, starting at study entry (<20 weeks' gestation) and continuing until delivery. These pellets will be non-xylitol placebo pellets of gum that otherwise taste and look the same as the intervention.
All gum will be pre-packaged into blister packs with the proper mix of Epic xylitol-containing chewing gum and/or placebo pellets to ensure the proper daily dose is administered per group the participant is randomized.
All patients who meet inclusion criteria will be approached without regard to race, ethnicity, parents' country of origin, or religious preferences.
- Being tested
- Xylitol Chewing gum, Sorbitol chewing gum
- Keywords
- xylitol, preterm birth, prematurity, pregnancy, periodontitis, periodontal disease, chewing gum
- Medical subject headings
- Premature Birth, Periodontitis, Gingivitis, Learning Disabilities, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xylitol Chewing gumDrug
Xylitol chewing gum (1 gram per pellet of gum). This is a dietary supplement, but clinicaltrials.gov requires us to identify it as a "drug" due to IND requirements.
Sorbitol chewing gumOther
Sorbitol (non-xylitol) chewing gum. This is a dietary supplement, but clinicaltrials.gov requires us to identify it as a "drug" due to IND requirements.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Sorbitol flavored chewing gum (0 grams of xylitol/day) Receives: Other: Sorbitol chewing gum |
| 2 grams xylitol/day | Experimental | Xylitol flavored chewing gum (2 grams of xylitol/day). The participants will receive 4 pellets of sorbitol (placebo) gum per day as well as 2 pellets of xylitol (intervention) gum per day in pre-packaged blister packs to ensure double-blinded study design. Receives: Drug: Xylitol Chewing gum; Other: Sorbitol chewing gum |
| 6 grams xylitol/day | Experimental | Xylitol flavored chewing gum (6 grams of xylitol/day) Receives: Drug: Xylitol Chewing gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm Birth
<37 weeks gestation
Measured: delivery
Low birthweight offspring
<2500 gram birthweight of offspring
Measured: at delivery
Secondary outcomes (5)
Neonatal mortality
Death of neonate between birth-28 days after birth
Measured: first 28 days after delivery
Infant Mortality
Death of neonate between birth and 1 year after birth
Measured: 1 year after birth
Neurodevelopmental Outcomes at 12 months
Bayley Scales of Infant and Toddler Development. Standardized score range from 0-200 with 100 being the median and 15 points being 1 standard deviation. Higher scores represent better outcomes. Domains of cognitive, motor, and language will be assessed.
Measured: 1 year after birth
Periodontitis
Periodontitis will be defined as (a) interdental clinical attachment level (CAL) detectable at ≥ 2 non-adjacent teeth, or (b) buccal or oral CAL ≥ 3 mm with pocketing ≥ 2 teeth but the observed CAL cannot be ascribed to non-periodontitis-related causes.116 The sites with periodontitis should have CAL ≥ 1 mm and probing depth ≥ 4 mm, along with the presence of bleeding on probing (BOP).
Measured: at 28-30 weeks of pregnancy at 6-8 weeks postpartum (in the enrolled pregnant individuals)
Gingivitis
Gingivitis will be defined as having ≥50% of the sites with bleeding on probing (BOP) in a full-mouth examination. By selecting ≥50% with BOP, we are seeking to capture significant differences in gingival inflammation consistent with our previous trials.
Measured: at 28-30 weeks of pregnancy at 6-8 weeks postpartum (in the enrolled pregnant individuals)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start26 Mar 2026
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm, Double-blind, placebo-controlled, individually randomized clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine, Baylor College of Medicine Children's Foundation, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Gregory C. Valentine, MD MED FAAP, University of Washington
- Investigators
- Greg Valentine, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424846
- Sponsor's protocol ID
- STUDY00018356
- Other IDs
- 1R01HD119029-01, 3R01HD119029-01S1
- Acronym
- XaPPP
- Status last verified
- Sep 2026
- First submitted
- 14 Feb 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data collected as part of the XaPPP trial will be preserved and shared as per NIH policy. Identifiers will not be shared to protect participant confidentiality. Biospecimens will not be shared unless data from the biospecimens has already been analyzed, which will be shared without identifiers.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xylitol and the Prevention of Periodontal Disease and Preterm Birth (XaPPP) Trial
- ClinicalTrials.gov ID
- NCT07424846
- Acronym / sponsor ID
- XaPPP / STUDY00018356
- Keywords
- xylitol, preterm birth, prematurity, pregnancy, periodontitis, periodontal disease, chewing gum
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Baylor College of Medicine, Baylor College of Medicine Children's Foundation, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 26 Mar 2026 (actual)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Given that xylitol-containing chewing gum is considered a prebiotic and known to reduce cariogenic and periodontopathic bacteria, the study evaluated and discovered a statistically significant reduction in maternal periodontal disease, preterm birth, and low birthweight offspring among pregnant individuals who chewed xylitol-containing chewing gum.
While PPaX demonstrated the efficacy of xylitol to reduce preterm birth (PTB), the study had important limitations: (a) PPaX was an unblinded cluster-randomized study with only 8 clusters, 4 with xylitol-containing chewing gum and 4 without any gum (not placebo-controlled); (b) PPaX used a suboptimal dose of 2 grams of xylitol daily which may have reduced the effectiveness of the intervention given that recent literature suggests 5-10 grams/day more effectively improve oral health; and (c) PPaX did not evaluate infant mortality nor early neurodevelopmental outcomes. Notably, reducing fetal exposure to periodontal disease (PD) as well as PTB may improve neurodevelopmental outcomes for offspring as both prematurity and fetal exposure to inflammation are well-documented risk factors for neurodevelopmental delay (NDD) and infant mortality.
The investigators will conduct a double-blind, placebo-controlled, individually randomized clinical trial with 3 arms among Malawian pregnant individuals (n=6000) at <20 weeks of pregnancy with the co-primary outcomes being the incidence of PTB and low birthweight offspring. The 3 study arms (n=2000 each) will be (a) an optimized dose of xylitol-containing chewing gum (6.4 grams/day), (b) the PPaX trial xylitol dose (2.1 grams/day), or (c) flavored sorbitol gum base (placebo control). This trial overcomes the PPaX trial's limitations and will definitively answer whether xylitol prevents PTB in Malawi. The investigators will additionally collect biospecimens from a random sampling of the participants for biobanking for later analysis of inflammatory and microbiome alterations that may occur with xylitol exposure compared with placebo. The investigators hypothesize that pregnant individuals who chew xylitol-containing chewing gum will have a significant reduction in periodontal disease metrics at 28-30 weeks' gestation (e.g. bleeding on probing) as well as offspring with improved neurodevelopmental outcomes as assessed by the Bayley Scales of Infant and Toddler Development 4th edition and reduced risk of adverse pregnancy outcomes including preterm birth.
Detailed description
The hypothesis is that xylitol-containing chewing gum use compared to control (flavored gum base) during pregnancy, starting before 20 weeks' gestation, will lead to reduced risk of adverse pregnancy outcomes, namely preterm birth, as well as improved metrics of periodontal disease and improve neurodevelopmental outcomes of offspring at 2 years corrected gestational age, with most beneficial effect seen in those with 6.4 grams/day xylitol dose.
The study will utilize an individually randomized, placebo-controlled, double-blinded, phase II/III clinical trial with a 1:1:1 allocation ratio between xylitol-containing chewing gum (6.4 grams of xylitol/day), xylitol-containing chewing gum (2.1 grams of xylitol/day), and placebo (flavored gum base, sorbitol, 0 grams of xylitol/day).
Intervention (1st arm): Epic dental chewing gum (xylitol-containing chewing gum containing 1.06 grams xylitol/pellet). Participants will chew 6 Epic xylitol-containing chewing gum pellets each day (2 pellets three times daily in pre-made blister packs). Each participant will be instructed to chew 2 pieces of gum three times daily for 5 minutes each time starting at study entry (<20 weeks' gestation) and continuing until delivery.
Intervention (2nd arm): Epic dental chewing gum (xylitol-containing chewing gum containing 1.06 grams xylitol/pellet). Participants will chew 2 Epic xylitol-containing chewing gum pellets and 4 placebo gum pellets per day, representing 2 pellets three times daily in pre-made blister packs. Each participant will be instructed to chew 2 pieces of gum three times daily for 5 minutes each time starting at study entry (<20 weeks' gestation) and continuing until delivery.
Control: Flavored gum base (sorbitol) without xylitol, instructing the participants to chew 2 pieces of gum three times daily for 5 minutes each time, the same as the intervention, starting at study entry (<20 weeks' gestation) and continuing until delivery. These pellets will be non-xylitol placebo pellets of gum that otherwise taste and look the same as the intervention.
All gum will be pre-packaged into blister packs with the proper mix of Epic xylitol-containing chewing gum and/or placebo pellets to ensure the proper daily dose is administered per group the participant is randomized.
All patients who meet inclusion criteria will be approached without regard to race, ethnicity, parents' country of origin, or religious preferences.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm, Double-blind, placebo-controlled, individually randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Sorbitol chewing gumSorbitol flavored chewing gum (0 grams of xylitol/day) |
| 2 grams xylitol/day | Experimental | Drug: Xylitol Chewing gum, Other: Sorbitol chewing gumXylitol flavored chewing gum (2 grams of xylitol/day). The participants will receive 4 pellets of sorbitol (placebo) gum per day as well as 2 pellets of xylitol (intervention) gum per day in pre-packaged blister packs to ensure double-blinded study design. |
| 6 grams xylitol/day | Experimental | Drug: Xylitol Chewing gumXylitol flavored chewing gum (6 grams of xylitol/day) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 Chewing gumXylitol chewing gum (1 gram per pellet of gum). This is a dietary supplement, but clinicaltrials.gov requires us to identify it as a "drug" due to IND requirements. | Drug | 2 grams xylitol/day, 6 grams xylitol/day |
| Sorbitol chewing gumSorbitol (non-xylitol) chewing gum. This is a dietary supplement, but clinicaltrials.gov requires us to identify it as a "drug" due to IND requirements. | Other | 2 grams xylitol/day, Placebo |
Primary outcome
Preterm Birth
Time frame: delivery
<37 weeks gestation
Low birthweight offspring
Time frame: at delivery
<2500 gram birthweight of offspring
5 secondary outcomes
Neonatal mortality
Time frame: first 28 days after delivery
Infant Mortality
Time frame: 1 year after birth
Neurodevelopmental Outcomes at 12 months
Time frame: 1 year after birth
Periodontitis
Time frame: at 28-30 weeks of pregnancy at 6-8 weeks postpartum (in the enrolled pregnant individuals)
Gingivitis
Time frame: at 28-30 weeks of pregnancy at 6-8 weeks postpartum (in the enrolled pregnant individuals)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified data collected as part of the XaPPP trial will be preserved and shared as per NIH policy. Identifiers will not be shared to protect participant confidentiality. Biospecimens will not be shared unless data from the biospecimens has already been analyzed, which will be shared without identifiers.
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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.
Greg Valentine principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Xylitol Chewing gum and Sorbitol chewing gum in people with Preterm Birth and Low Birthweight Neonate, run by University of Washington at 1 site in Malawi.
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 12 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. 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 Malawi. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Greg Valentine, MD MED FAAP (2066167378 ext. (206) 543-3200, gcvalent@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preterm Birth (time frame: delivery). 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 10 Sep 2026.