Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:21 AM
Study NCT ID:
NCT07413393
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Health Education for Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-11', 'studyFirstSubmitDate': '2026-02-03', 'studyFirstSubmitQcDate': '2026-02-11', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Oral Health Knowledge, Attitudes, and Practices', 'timeFrame': '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.', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oral health', 'knowledge', 'pregnant', 'improvement'], 'conditions': ['Knowledge', 'Oral Health', 'Pregnant Women', 'Intervention']}, 'descriptionModule': {'briefSummary': '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:\n\nWhat is the level of oral health knowledge among pregnant women attending Hospital La Fe?\n\nDoes a one-time informational intervention, delivered through a printed leaflet, improve oral health knowledge during pregnancy?\n\nWhat factors are related to differences in oral health knowledge among pregnant women?\n\nParticipants are pregnant women receiving care at Hospital La Fe. They will:\n\nComplete a questionnaire about their oral health knowledge.\n\nReceive a printed informational leaflet about oral health during pregnancy.\n\nComplete the same questionnaire again after a period of time to see if their knowledge has changed.\n\nResearchers 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18-45 who have recently given birth to healthy babies, either vaginally or by cesarean section.\n* Ability to understand and speak Spanish.\n\nExclusion Criteria:\n\n* Complications during pregnancy or delivery.\n* Newborns with major birth defects.\n* Participants who do not provide informed consent.'}, 'identificationModule': {'nctId': 'NCT07413393', 'briefTitle': 'Oral Health Education for Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Valencia'}, 'officialTitle': 'Knowledge of Oral Health in Pregnant Women: Effect of a Short Educational Intervention', 'orgStudyIdInfo': {'id': '2021-784-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Pregnant Women Receiving an Informational Leaflet', 'description': '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.', 'interventionNames': ['Other: Informational Leaflet']}], 'interventions': [{'name': 'Informational Leaflet', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Pregnant Women Receiving an Informational Leaflet']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Valencia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Montserrat Catalá Pizarro', 'investigatorAffiliation': 'University of Valencia'}}}}