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Accuracy of eDiagEPU, a Medical Computerized Tool for EPU

eDiagEPU, a Computerized Help to Diagnosis for Early Pregnancy Unit : a Retrospective Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03993015
Acronym
eDiagEPU
Enrollment
300
Registered
2019-06-20
Start date
2019-07-01
Completion date
2019-12-31
Last updated
2020-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnant Women Less Than 14 Weeks of Gestation

Keywords

Viable pregnancy, miscarriage, ectopic pregnancy, early pregnancy

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.

Interventions

OTHERHelp to diagnosis software

Help to diagnosis software

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Pregnancy of unknown location (hCG + without gestational sac found in ultrasound) * Viable pregnancy with embryo less than 14 weeks of gestation * Non-viable pregnancy ; ectopic pregnancy, complete, incomplete or missed miscarriage

Exclusion criteria

\- Incomplete follow up and no diagnosis and lack of data to establish a diagnosis

Design outcomes

Primary

MeasureTime frameDescription
tyde of Medical diagnosis (senior physician)1 weekMedical diagnosis retained by senior physician at the end of the management of the patient
tyde of Medical diagnosis (diagnosis tool)1 weekMedical diagnosis proposed by the diagnosis tool

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026