Accuracy of eDiagEPU, a Medical Computerized Tool for EPU

Pregnant Women Less Than 14 Weeks of Gestation Clinical Trial

— eDiagEPU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03993015
• Other study ID #: RECHMPL19_0284
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 31, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnant Women Less Than 14 Weeks of Gestation

Intervention

Other:
• Help to diagnosis software
Help to diagnosis software

Locations

Country	Name	City	State
France	Uh Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tyde of Medical diagnosis (senior physician)	Medical diagnosis retained by senior physician at the end of the management of the patient	1 week
Primary	tyde of Medical diagnosis (diagnosis tool)	Medical diagnosis proposed by the diagnosis tool	1 week