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Completed

NCT Number: NCT03993015

Accuracy of eDiagEPU, a Medical Computerized Tool for EPU

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.

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Key information

Conditions

Pregnant Women Less Than 14 Weeks of Gestation Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Pregnancy, Ectopic Urogenital Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Uh Montpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Help to diagnosis software

Other

Help to diagnosis software

Primary outcomes

  1. tyde of Medical diagnosis (senior physician)

    Time frame: 1 week

    Medical diagnosis retained by senior physician at the end of the management of the patient

  2. tyde of Medical diagnosis (diagnosis tool)

    Time frame: 1 week

    Medical diagnosis proposed by the diagnosis tool

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: eDiagEPU

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 20, 2019
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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