Pregnant Women Less Than 14 Weeks of GestationeDiagEPUNCT03993015
Accuracy of eDiagEPU, a Medical Computerized Tool for EPU
An observational study of Pregnant Women Less Than 14 Weeks of Gestation, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women Less Than 14 Weeks of Gestation
- What is being tested?
- Help to diagnosis software
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2019to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women less than 14 weeks of gestation
Who may be able to join
- 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
Who cannot join
- Incomplete follow up and no diagnosis and lack of data to establish a diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: eDiagEPU, a Computerized Help to Diagnosis for Early Pregnancy Unit : a Retrospective Study
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.
Read the 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.
- Being tested
- Help to diagnosis software
- Keywords
- Viable pregnancy, miscarriage, ectopic pregnancy, early pregnancy
- Medical subject headings
- Abortion, Spontaneous, Pregnancy, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Help to diagnosis softwareOther
Help to diagnosis software
| Study group | Role | What they receive |
|---|---|---|
| Patients attending the Obstetrical Emergency Unit | Patients attending the Obstetrical Emergency Unit of CHU Montpellier during 2018 Receives: Other: Help to diagnosis software |
What is being measured
The primary outcome is the main question the study is designed to answer.
tyde of Medical diagnosis (senior physician)
Medical diagnosis retained by senior physician at the end of the management of the patient
Measured: 1 week
tyde of Medical diagnosis (diagnosis tool)
Medical diagnosis proposed by the diagnosis tool
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start1 Jul 2019
- Primary completion1 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pregnant Women Less Than 14 Weeks of GestationStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederic BLAVIER, M.D, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993015
- Sponsor's protocol ID
- RECHMPL19_0284
- Acronym
- eDiagEPU
- Status last verified
- Mar 2020
- First submitted
- 17 Jun 2019
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
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.
PubMed 30182449Blavier 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.
PubMed 36762880
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- eDiagEPU, a Computerized Help to Diagnosis for Early Pregnancy Unit : a Retrospective Study
- ClinicalTrials.gov ID
- NCT03993015
- Acronym / sponsor ID
- eDiagEPU / RECHMPL19_0284
- Keywords
- Viable pregnancy, miscarriage, ectopic pregnancy, early pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients attending the Obstetrical Emergency Unit | – | Other: Help to diagnosis softwarePatients attending the Obstetrical Emergency Unit of CHU Montpellier during 2018 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women less than 14 weeks of gestation
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Incomplete follow up and no diagnosis and lack of data to establish a diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Help to diagnosis softwareHelp to diagnosis software | Other | Patients attending the Obstetrical Emergency Unit |
Primary outcome
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
tyde of Medical diagnosis (diagnosis tool)
Time frame: 1 week
Medical diagnosis proposed by the diagnosis tool
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Results publication: PubMed 30182449Blavier 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.
- Derived from this study: PubMed 36762880Blavier 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.
- Individual participant dataSharing planned: Undecided. NC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederic BLAVIER, M.D principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnant Women Less Than 14 Weeks of Gestation, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tyde of Medical diagnosis (senior physician) (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03993015, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.