UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057519 |
|---|---|
| Receipt number | R000065719 |
| Scientific Title | Integration of Oral Health Care into the Maternal and Child Health Continuum of Care: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/04/04 |
| Last modified on | 2026/04/05 09:09:42 |
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Basic information
Public title
Integration of Oral Health Care into the Maternal and Child Health Continuum of Care
Acronym
Oral Health and Maternal and Child Health Continuum of Care
Scientific Title
Integration of Oral Health Care into the Maternal and Child Health Continuum of Care: A Randomized Controlled Trial
Scientific Title:Acronym
Oral Health and Maternal and Child Health Continuum of Care: A Randomized Controlled Trial
Region
| Asia(except Japan) |
Condition
Condition
Preterm birth, Periodontal disease
Classification by specialty
| Obstetrics and Gynecology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct a new Continuum of Care intervention integrating oral health care into maternal and child health care in Bangladesh and to test its effectiveness in improving maternal and child health indicators and oral health through a randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Preterm birth
Key secondary outcomes
Birthweight, Periodontal disease, Oral Health-related QoL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Intervention group: Half of the study participants with periodontal disease will receive basic periodontal treatment and continue mouthwash use during pregnancy.
Interventions/Control_2
Control group 1: The other half of the study participants with periodontal disease will receive basic periodontal treatment and continue mouthwash use after delivery.
Interventions/Control_3
Control group 2: Study participants without periodontal disease will not receive basic periodontal treatment or mouthwash.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Pregnant women who receive antenatal checkups at the hospital selected as the study site
2) Pregnant women who are at least 18 years of age and less than 20 weeks pregnant at the time consent is obtained
3) Those who have provided written consent to participate in the study
Key exclusion criteria
1) Pregnant women who have been diagnosed with a multiple pregnancy during antenatal checkups prior to obtaining consent.
2) Pregnant women who have been identified as having a high-risk pregnancy, such as hypertension or diabetes, during antenatal checkups prior to obtaining consent.
3) Individuals deemed unsuitable for participation by the principal investigator, co-investigators, or local obstetricians, midwives, or dentists trained in this study, due to reasons such as infectious diseases, abdominal pain or other health conditions, or mental disorders that may hinder their ability to respond to interviews.
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Yasuoka |
Organization
St. Luke's International University
Division name
Graduate School of Public Health
Zip code
104-0045
Address
OMURA Susumu & Mieko Memorial St. Luke's Center for Clinical Academia, 5th Floor, 3-6-2 Tsukiji, Chuo-ku, Tokyo
TEL
03-5550-4101
yasuoka@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Yasuoka |
Organization
St. Luke's International University
Division name
Graduate School of Public Health
Zip code
104-0045
Address
St. Luke's Center for Clinical Academia, 5th Floor, 3-6-2 Tsukiji, Chuo-ku, Tokyo
TEL
03-5550-4101
Homepage URL
yasuoka@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Junko Yasuoka
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St Luke's International University Research Ethics Committee
Address
Akashi-cho 10-1, Chuo-ku, Tokyo
Tel
03-5550-2423
kenkyukikaku@luke.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
As of April 2026, baseline data collection has been completed. The intervention and endline data collection are currently ongoing.
Management information
Registered date
| 2025 | Year | 04 | Month | 04 | Day |
Last modified on
| 2026 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065719
