CClinicalTrials.gg
RecruitingNCT07413393Updated Jul 30, 2026

Oral Health Education for Pregnant Women

An interventional study of Informational Leaflet in Knowledge, Oral Health and Pregnant Women, sponsored by University of Valencia. Recruiting at 1 site in Spain. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by University of Valencia · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Knowledge
  • Oral Health
  • Pregnant Women
  • Intervention

Keywords

  • oral health
  • knowledge
  • pregnant
  • improvement
03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Complications during pregnancy or delivery.
  • Newborns with major birth defects.
  • Participants who do not provide informed consent.
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • 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.

    Other: Informational Leaflet

Interventions

  • OtherInformational Leaflet

    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.

05

What researchers measure

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.

    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.

06

Study locations

1 of 1 sites recruiting
  • Hospital Universitario La Fe
    Valencia, Valencia 46021, Spain
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07413393
Lead sponsor
University of Valencia
Responsible party
Montserrat Catalá Pizarro (Associate Professor of Medicine, University of Valencia) — Principal investigator
First posted
Feb 17, 2026
Start date
Feb 15, 2026
Primary completion
May 14, 2026
Completion
Jul 29, 2026 (estimated)
Last update
Jul 30, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion