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

NCT02333227 | Completed Results

• 2 other identifiers: NHSRC # 1030H-35933
• Study Type: interventional
• Target: 10,069
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Preterm Birth; Periodontal Disease; Caries, Dental

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Date of delivery to 1 week postnatal

Secondary Outcomes (3)

• Number of Infants With Adverse Neonatal Composite Morbidity and Mortality

  Date of delivery to 28 days postnatal

• Number of Participants With Periodontal Disease

  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

  During pregnancy, up to 2 dental visits performed during pregnancy (approximately 37-40 weeks if term) to evaluate dental outcomes

Study Arms (2)

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.

Dietary Supplement: Xylitol gum

Interventions

Xylitol gum DIETARY_SUPPLEMENT

This is a cluster randomized trial, whereby 4 sites will receive the intervention of xylitol gum in the prepregnancy and early pregnancy interval.

Xylitol

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• \>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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Premature Birth; Periodontal Diseases; Dental Caries

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases

Results Point of Contact

• Title: Dr. Kjersti Aagaard
• Organization: Baylor College of Medicine, Department of Obstetrics & Gynecology, Division of Maternal-Fetal Medicine

aagaardt@bcm.edu

7137988467

Study Officials

• Kjersti Aagaard, M.D.

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Vice Chair of Research

Study Record Dates

• First Submitted: December 23, 2014
• First Posted: January 7, 2015
• Study Start: May 1, 2015
• Primary Completion: October 31, 2021
• Study Completion: December 1, 2021
• Last Updated: January 8, 2024
• Results First Posted: January 8, 2024

Record last verified: 2023-03

Locations

US (1)