Accuracy of eDiagEPU, a Medical Computerized Tool for EPU

Completed

• Conditions: Pregnant Women Less Than 14 Weeks of Gestation
• Interventions: Other: Help to diagnosis software

• Registration Number: NCT03993015
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

In a recently published study, a poor knowledge of guidelines in the field of early pregnancy was observed in France, Belgium and Switzerland. To improve the respect of the most recent criteria of diagnoses, a computerized tool was developped.

Detailed Description

In December 2018, the investigators published an prospective multinational survey, with 17 questions that assessed the participants' knowledge, interest, and management of early pregnancy in France, Belgium and Switzerland1. Knowledge about early management of pregnancy was limited among the practitioners surveyed ; 211/306 (69.0%) participants reported incorrect management when they visualized a gestational sac without embryo and 265/306 (86.6%) misinterpreted changes in serum levels of chorionic gonadotropin during early pregnancy.

To fill this gap, the investigators developped a computerized tool who is following strictly the most recent criteria of diagnoses in the field of early pregnancy. This tool should be evaluated in an observational study, using data of real patients without modification of their management.

Study Timeline

• Study First Submitted: 2019-06-17
• Study First Submitted QC: 2019-06-17
• Study First Posted: 2019-06-20
• Study Start: 2019-07-01
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients attending the Obstetrical Emergency Unit	Help to diagnosis software	Patients attending the Obstetrical Emergency Unit of CHU Montpellier during 2018

Primary Outcome Measures

Name	Time	Method
tyde of Medical diagnosis (senior physician)	1 week	Medical diagnosis retained by senior physician at the end of the management of the patient
tyde of Medical diagnosis (diagnosis tool)	1 week	Medical diagnosis proposed by the diagnosis tool

Trial Locations

Locations (1)

Uh Montpellier; 🇫🇷 Montpellier, France