Accuracy of eDiagEPU, a Medical Computerized Tool for EPU

NCT ID: NCT03993015

Last Updated: 2020-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Pregnant Women Less Than 14 Weeks of Gestation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients attending the Obstetrical Emergency Unit

Patients attending the Obstetrical Emergency Unit of CHU Montpellier during 2018

Help to diagnosis software

Intervention Type OTHER

Help to diagnosis software

Interventions

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Help to diagnosis software

Help to diagnosis software

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frederic BLAVIER, M.D

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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Uh Montpellier

Montpellier, , France

Site Status

Countries

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France

References

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Blavier F, Cosyns S, Dony N, Faron G, Parra J, Gucciardo L. Perception and knowledge of early pregnancy assessment units among perinatal practitioners in Europe. Int J Gynaecol Obstet. 2018 Dec;143(3):289-299. doi: 10.1002/ijgo.12661. Epub 2018 Sep 21.

Reference Type RESULT
PMID: 30182449 (View on PubMed)

Blavier F, Grobet D, Duflos C, Rayssiguier R, Ranisavljevic N, Duport Percier M, Rodriguez A, Blockeel C, Santos-Ribeiro S, Faron G, Gucciardo L, Fuchs F. Usability, accuracy, and cost-effectiveness of a medical software for early pregnancies: a retrospective study. Hum Reprod. 2023 Apr 3;38(4):549-559. doi: 10.1093/humrep/dead025.

Reference Type DERIVED
PMID: 36762880 (View on PubMed)

Other Identifiers

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RECHMPL19_0284

Identifier Type: -

Identifier Source: org_study_id

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