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Accuracy of eDiagEPU, a Medical Computerized Tool for EPU

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Completed

Conditions

Pregnant Women Less Than 14 Weeks of Gestation

Treatments

Other: Help to diagnosis software

Study type

Observational

Funder types

Other

Identifiers

NCT03993015
RECHMPL19_0284

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 patients

Sex

Female

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

300 participants in 1 patient group

Patients attending the Obstetrical Emergency Unit
Description:
Patients attending the Obstetrical Emergency Unit of CHU Montpellier during 2018
Treatment:
Other: Help to diagnosis software

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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