NCT07413393

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Feb 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress50%
Feb 2026Jul 2026

First Submitted

Initial submission to the registry

February 3, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

February 15, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

February 3, 2026

Last Update Submit

February 11, 2026

Conditions

Keywords

oral healthknowledgepregnantimprovement

Outcome Measures

Primary Outcomes (1)

  • Change in Oral Health Knowledge, Attitudes, and Practices

    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.

Study Arms (1)

Pregnant Women Receiving an Informational Leaflet

OTHER

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.

Other: Informational Leaflet

Interventions

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.

Pregnant Women Receiving an Informational Leaflet

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 18-45 who have recently given birth to healthy babies, either vaginally or by cesarean section.
  • Ability to understand and speak Spanish.

You may not qualify if:

  • Complications during pregnancy or delivery.
  • Newborns with major birth defects.
  • Participants who do not provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

February 3, 2026

First Posted

February 17, 2026

Study Start

February 15, 2026

Primary Completion (Estimated)

May 14, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

February 17, 2026

Record last verified: 2026-02