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NCT02333227 · ClinicalTrials.gov registry record · NA

Saving Lives at Birth: Primary Prevention of Periodontal Disease in Relation to Preterm Birth in Malawi

A NA study, sponsored by Baylor College of Medicine.

Completed
Registry status
NA
Development phase
10,069
Enrollment target

NCT02333227: Completed NA study, sponsored by Baylor College of Medicine.

NCT02333227 is a NA study that has completed, run by Baylor College of Medicine. The registered enrollment target is 10,069 participants, above the 1,403-participant average among 58,714 other NA trials with a reported enrollment target (618% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02333227, a NA study, has completed, sponsored by Baylor College of Medicine.

COMPLETED
Registry status
NA
Development phase
10,069 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • DIETARY_SUPPLEMENT Xylitol gum

Trial Details

FieldValue
Enrollment Target 10,069 participants
Start Date 2015-05-01
Est. Completion 2021-12-01
Phase NA
Baylor College of Medicine

616 total trials

What the finished NCT02333227 record still lists

NCT02333227 is an interventional study that assigns participants to a tested intervention. Its 10,069 participants enrollment target places it among the larger protocols in the corpus, above the 1,403-participant average among 58,714 other NA trials with a reported enrollment target (618% higher).

The record links to 0 conditions, and to 1 intervention - of which Xylitol gum is the first listed.

NCT02333227 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02333227 about?

NCT02333227 is a clinical study titled "Saving Lives at Birth: Primary Prevention of Periodontal Disease in Relation to Preterm Birth in Malawi". 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.

What is the current status of trial NCT02333227?

This trial is currently completed. It is a NA study. The enrollment target is 10,069 participants. The study started on 2015-05-01. Estimated completion is 2021-12-01.

What interventions are being tested in trial NCT02333227?

The interventions under investigation include: Xylitol gum (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT02333227?

This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02333227's enrollment target sits among peer trials

10,069 14th of 2000 higher than 1,987 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02333227, the US trial registry maintained by the National Library of Medicine. NCT02333227 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.