- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07413393
Oral Health Education for Pregnant Women
Knowledge of Oral Health in Pregnant Women: Effect of a Short Educational Intervention
The goal of this research is to investigate oral health knowledge in pregnant women receiving care at Hospital La Fe and to see whether a one-time informational intervention improves this knowledge. The main questions this research aims to answer are:
What is the level of oral health knowledge among pregnant women attending Hospital La Fe?
Does a one-time informational intervention, delivered through a printed leaflet, improve oral health knowledge during pregnancy?
What factors are related to differences in oral health knowledge among pregnant women?
Participants are pregnant women receiving care at Hospital La Fe. They will:
Complete a questionnaire about their oral health knowledge.
Receive a printed informational leaflet about oral health during pregnancy.
Complete the same questionnaire again after a period of time to see if their knowledge has changed.
Researchers will compare answers before and after the leaflet is provided to see whether oral health knowledge improves. They will also explore which personal or social factors are linked to different levels of oral health knowledge.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women aged 18-45 who have recently given birth to healthy babies, either vaginally or by cesarean section.
- Ability to understand and speak Spanish.
Exclusion Criteria:
- Complications during pregnancy or delivery.
- Newborns with major birth defects.
- Participants who do not provide informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Pregnant Women Receiving an Informational Leaflet
A printed informational leaflet is developed with two sections: "For Mothers" and "About the Baby," following international pediatric dentistry recommendations.
A pilot study tests the clarity and completion time of the questionnaires.
Participants are informed about the study, sign the consent form, and complete an initial questionnaire about oral health knowledge during their hospital visit.
They receive the leaflet and complete the same questionnaire again after a period of time to assess changes.
Most follow-up questionnaires are conducted by phone.
|
The intervention consists of a printed informational leaflet for pregnant women.
The leaflet has two sections: "For Mothers," which explains oral health care during pregnancy, and "About the Baby," which provides oral health recommendations for the newborn.
The content is based on recommendations from international and national pediatric dentistry associations (AAPD, EAPD, ALOP, SEOP).
Participants read the leaflet during their hospital visit and take it home for reference.
The leaflet aims to improve participants' knowledge, attitudes, and practices regarding oral health during pregnancy and in the first years of the child's life.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Oral Health Knowledge, Attitudes, and Practices
Time Frame: From the date of administration of the first questionnaire (February 2026) to the date of completion of the second questionnaire following the intervention, assessed up to 39 weeks.
|
Participants complete a questionnaire about oral health knowledge, attitudes, and practices during pregnancy and in the first years of the child's life.
The difference between baseline and follow-up scores is analyzed to assess whether the informational leaflet improves knowledge, attitudes, and practices.
|
From the date of administration of the first questionnaire (February 2026) to the date of completion of the second questionnaire following the intervention, assessed up to 39 weeks.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2021-784-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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