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Search / Trial NCT06694428

Evaluation of Software for Interpreting Virological Results Indicated for the Diagnosis of Cytomegalovirus (CMV) Infection During Pregnancy and Intended for Health Professionals

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Nov 15, 2024

Trial Information

Current as of May 28, 2025

Not yet recruiting

Keywords

Congenital Cytomegalovirus (C Cmv) Infection Maternal Primary Cytomegalovirus Infection Maternal Screening And Diagnosis Decision Making Algorithm

ClinConnect Summary

This clinical trial is studying a new software tool called MyCMV, designed to help healthcare professionals quickly and accurately interpret test results for Cytomegalovirus (CMV) infections during pregnancy. CMV is a common virus that can be harmful to unborn babies, especially if a mother becomes infected for the first time during her pregnancy. The goal of the trial is to see if using the MyCMV tool can help detect primary CMV infections earlier in pregnant women, which is important for starting treatment and reducing risks to the baby.

To participate in this trial, women must be pregnant and have had a blood test for CMV antibodies that shows a positive result for certain markers. They should also know when their pregnancy started and be okay with researchers using their health information for this study. If eligible, participants will help researchers understand how effective the MyCMV tool is in identifying CMV infections compared to the traditional methods used by experts. This could lead to faster and better care for mothers and their babies.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Pregnant woman
  • And for whom a CMV serology including the search for CMV IgG and IgM antibodies is prescribed at the Necker-Enfants Malades or Paul Brousse hospital
  • And with positive anti-CMV IgM or in the grey zone of the technique
  • And for whom the date of start of pregnancy is known
  • And who does not object to the use of their data in the context of this research
  • Exclusion Criteria: NA

About Assistance Publique Hôpitaux De Paris

Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.

Locations

Villejuif, , France

Paris, , France

Patients applied

0 patients applied

Trial Officials

Marianne Leruez-Ville, M.D., PhD

Study Director

Assistance Publique - Hôpitaux de Paris

Jacques Fourgeaud, Pharma.D., PhD

Principal Investigator

Assistance Publique - Hôpitaux de Paris

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported