Trial Outcomes & Findings for Saving Lives at Birth: Primary Prevention of Periodontal Disease in Relation to Preterm Birth in Malawi (NCT NCT02333227)
NCT ID: NCT02333227
Last Updated: 2024-01-08
Results Overview
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.
COMPLETED
NA
10069 participants
Conception to date of delivery, <37 weeks gestation
2024-01-08
Participant Flow
Recruitment through outpatient prenatal clinics
All patients who were eligible and consented for the study were enrolled and designated into either a control or intervention group based on this cluster-randomized design and the site of enrollment where the participant initially presented.
Unit of analysis: 8
Participant milestones
| Measure |
Control
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
Cluster of sites receiving xylitol gum.
Xylitol gum: This is a cluster randomized trial, whereby 4 sites will receive the intervention of xylitol gum in the prepregnancy and early pregnancy interval.
|
|---|---|---|
|
Overall Study
STARTED
|
5520 4
|
4549 4
|
|
Overall Study
COMPLETED
|
5321 4
|
4349 4
|
|
Overall Study
NOT COMPLETED
|
199 0
|
200 0
|
Reasons for withdrawal
| Measure |
Control
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
Cluster of sites receiving xylitol gum.
Xylitol gum: This is a cluster randomized trial, whereby 4 sites will receive the intervention of xylitol gum in the prepregnancy and early pregnancy interval.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
137
|
106
|
|
Overall Study
Pregnancy Interrupted
|
42
|
89
|
|
Overall Study
Enrolled prepregnant without neonatal outcome data available
|
20
|
5
|
Baseline Characteristics
Saving Lives at Birth: Primary Prevention of Periodontal Disease in Relation to Preterm Birth in Malawi
Baseline characteristics by cohort
| Measure |
Control
n=5520 Participants
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
n=4549 Participants
Cluster of sites receiving xylitol gum.
Xylitol gum: This is a cluster randomized trial, whereby 4 sites will receive the intervention of xylitol gum in the prepregnancy and early pregnancy interval.
|
Total
n=10069 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5520 Participants
n=99 Participants
|
4549 Participants
n=107 Participants
|
10069 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
5520 Participants
n=99 Participants
|
4549 Participants
n=107 Participants
|
10069 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African, black
|
5520 Participants
n=99 Participants
|
4549 Participants
n=107 Participants
|
10069 Participants
n=206 Participants
|
|
Region of Enrollment
Malawi
|
5520 participants
n=99 Participants
|
4549 participants
n=107 Participants
|
10069 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Conception to date of delivery, <37 weeks gestationThis 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.
Outcome measures
| Measure |
Control
n=5321 Participants
Control group (no xylitol gum exposure)
|
Xylitol
n=4349 Participants
Intervention group (twice daily xylitol gum use during pregnancy)
|
|---|---|---|
|
Rate of Preterm Birth
|
878 Participants
|
549 Participants
|
PRIMARY outcome
Timeframe: Date of delivery to 1 week postnatalPopulation: There were 5260 of the 5520 subjects in the control group after removing 42 with an interrupted pregnancy, 20 prepregnant without information on neonatal outcomes, 137 lost to follow up, and 61 with only neonatal gestational age information. There were 4305 of 4349 consented for enrollment in the xylitol intervention group, after removing 89 with an interrupted pregnancy, 5 prepregnant without neonatal outcomes data, 106 lost to follow up and 45 with only neonatal gestational age data.
This is a co-primary outcome: Measured weight at delivery to determine the rate of \<2500 gram infants.
Outcome measures
| Measure |
Control
n=5260 Participants
Control group (no xylitol gum exposure)
|
Xylitol
n=4305 Participants
Intervention group (twice daily xylitol gum use during pregnancy)
|
|---|---|---|
|
Number of Infants <2500 Grams
|
679 Participants
|
385 Participants
|
SECONDARY outcome
Timeframe: Date of delivery to 28 days postnatalAdditive or singular composite neonatal morbidity up to 28 days of age. Composite neonatal morbidity and mortality outcomes are defined as: neonatal death, miscarriage \<28 weeks, stillbirth (fresh or macerated), neonatal sepsis, neonatal respiratory distress, neonatal seizures, feeding problems, fever, hypothermia, Apgar score \<7 at 5 minutes after birth, referral to other hospital or neonatal intensive care unit (NICU)
Outcome measures
| Measure |
Control
n=5321 Participants
Control group (no xylitol gum exposure)
|
Xylitol
n=4349 Participants
Intervention group (twice daily xylitol gum use during pregnancy)
|
|---|---|---|
|
Number of Infants With Adverse Neonatal Composite Morbidity and Mortality
|
238 Participants
|
133 Participants
|
SECONDARY outcome
Timeframe: During pregnancy, up to 2 dental visits performed during pregnancy (approximately 37-40 weeks if term) to evaluate dental outcomesPopulation: There were 461 subjects in the control group who completed at least 2 dental visits. There were 490 subjects in the intervention, xylitol group who completed at least 2 dental visits.
We will measure the prevalence of periodontal disease among gravidae. We will use standardized World Health Organization (WHO) oral health forms and disease scoring.
Outcome measures
| Measure |
Control
n=461 Participants
Control group (no xylitol gum exposure)
|
Xylitol
n=490 Participants
Intervention group (twice daily xylitol gum use during pregnancy)
|
|---|---|---|
|
Number of Participants With Periodontal Disease
|
117 Participants
|
102 Participants
|
SECONDARY outcome
Timeframe: During pregnancy, up to 2 dental visits performed during pregnancy (approximately 37-40 weeks if term) to evaluate dental outcomesPopulation: There were 461 subjects in the control group who completed at least 2 dental visits. There were 490 subjects in the intervention, xylitol group who completed at least 2 dental visits.
We will measure the prevalence of dental caries among gravidae. We will use standardized World Health Organization (WHO) oral health forms and disease scoring.
Outcome measures
| Measure |
Control
n=461 Participants
Control group (no xylitol gum exposure)
|
Xylitol
n=490 Participants
Intervention group (twice daily xylitol gum use during pregnancy)
|
|---|---|---|
|
Number of Participants With Dental Caries
|
123 Participants
|
135 Participants
|
Adverse Events
Control
Xylitol
Serious adverse events
| Measure |
Control
n=5520 participants at risk
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
n=4549 participants at risk
Cluster of sites receiving xylitol gum.
Xylitol gum: This is a cluster randomized trial, whereby 4 sites will receive the intervention of xylitol gum in the prepregnancy and early pregnancy interval.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Death
|
0.04%
2/5520 • 4 years; Data was collected from study enrollment in 2015 through 2019 during which study participants were enrolled and completed the study. An additional 2 year follow-up period occurred from 2019-2021 in which data was verified and cross-validated with local maternal delivery logbooks
|
0.00%
0/4549 • 4 years; Data was collected from study enrollment in 2015 through 2019 during which study participants were enrolled and completed the study. An additional 2 year follow-up period occurred from 2019-2021 in which data was verified and cross-validated with local maternal delivery logbooks
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Kjersti Aagaard
Baylor College of Medicine, Department of Obstetrics & Gynecology, Division of Maternal-Fetal Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place