NCT07643116

Brief Summary

This prospective randomized study aims to compare the impact of three Case-Based Learning (CBL) approaches on knowledge acquisition, knowledge retention, and clinical reasoning development among third-year medical students during their obstetrics and gynecology rotation. Participants are randomly assigned to one of three groups: CBL without concept mapping, CBL with a teacher-constructed concept map, or CBL with a concept map co-constructed by students during the learning session. Knowledge acquisition and retention are assessed using pre-tests, immediate post-tests, and delayed post-tests. Clinical reasoning and knowledge organization are evaluated using a synthesis exercise. The study seeks to determine whether concept mapping and the modality of its integration into CBL enhance learning outcomes and clinical reasoning skills in undergraduate medical education.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

June 7, 2026

Last Update Submit

June 7, 2026

Conditions

Keywords

Medical EducationCase-Based LearningCBLConcept MappingClinical ReasoningKnowledge AcquisitionKnowledge RetentionUndergraduate Medical EducationMedical StudentsPreeclampsiaEducational InterventionActive Learning

Outcome Measures

Primary Outcomes (1)

  • Clinical Reasoning Score

    Assessment of knowledge organization and clinical reasoning development using the synthesis question score (NQS)

    Immediately after completion of the Case-Based Learning session

Secondary Outcomes (2)

  • Knowledge Acquisition Score

    Immediately after completion of the learning session

  • Knowledge Retention Score

    Two weeks after completion of the learning session

Study Arms (3)

CBL Without Concept Mapping

EXPERIMENTAL

Participants receive a Case-Based Learning session without the use of concept mapping.

Behavioral: Case-Based Learning Without Concept Mapping

CBL With Teacher-Constructed Concept Map

EXPERIMENTAL

Participants receive a Case-Based Learning session supplemented by a concept map prepared and presented by the instructor.

Behavioral: Teacher-Constructed Concept Mapping

CBL With Student Co-Constructed Concept Map

EXPERIMENTAL

Participants receive a Case-Based Learning session supplemented by a concept map progressively developed by students under instructor supervision.

Behavioral: Student Co-Constructed Concept Mapping

Interventions

Participants receive a Case-Based Learning session without the use of concept mapping.

CBL Without Concept Mapping

Participants receive a Case-Based Learning session supplemented by a concept map designed and presented by the instructor.

CBL With Teacher-Constructed Concept Map

Participants receive a Case-Based Learning session supplemented by a concept map progressively developed by students under instructor supervision.

CBL With Student Co-Constructed Concept Map

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Third-year medical students enrolled in the Obstetrics and Gynecology rotation.
  • Completion of the preeclampsia learning module before the educational session.
  • Provision of informed consent.

You may not qualify if:

  • Refusal to participate.
  • Failure to complete the pre-test, post-test, synthesis assessment, or delayed -post-test.
  • Absence from the educational session.
  • Incomplete study data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maternity and Neonatology Center of Tunis

Tunis, Tunisia

Location

Related Publications (3)

  • Torre DM, Durning SJ, Daley BJ. Twelve tips for teaching with concept maps in medical education. Med Teach. 2013;35(3):201-8. doi: 10.3109/0142159X.2013.759644.

    PMID: 23464896BACKGROUND
  • Thistlethwaite JE, Davies D, Ekeocha S, Kidd JM, MacDougall C, Matthews P, Purkis J, Clay D. The effectiveness of case-based learning in health professional education. A BEME systematic review: BEME Guide No. 23. Med Teach. 2012;34(6):e421-44. doi: 10.3109/0142159X.2012.680939.

    PMID: 22578051BACKGROUND
  • Novak JD, Cañas AJ. The Theory Underlying Concept Maps and How to Construct and Use Them. Technical Report IHMC CmapTools. 2008.

    BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned to one of three parallel groups: Case-Based Learning without concept mapping, Case-Based Learning with a teacher-constructed concept map, or Case-Based Learning with a student co-constructed concept map. Learning outcomes and clinical reasoning are compared across groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesiology and Critical Care, Principal Investigator

Study Record Dates

First Submitted

June 7, 2026

First Posted

June 11, 2026

Study Start

February 1, 2026

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

June 11, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations