Assessment of Post-traumatic Stress Disorder (PTSD) in Patients Monitored for Cytomegalovirus (CM… (NCT04658810) | Clinical Trial Compass
CompletedNot Applicable
Assessment of Post-traumatic Stress Disorder (PTSD) in Patients Monitored for Cytomegalovirus (CMV) Seroconversion During Pregnancy,
France87 participantsStarted 2021-05-02
Plain-language summary
Reports of maternal seroconversion to CMV during pregnancy can be extremely stressful. This virus is little known to the general public and searching for information on the Internet quickly leads to a consultation of a site mentioning the risk of severe psychomotor retardation in the event of prenatal cytomegalovirus infection.
The psychological repercussions in the event of prenatal CMV infection with criteria of severity, leading or not to a request for IMG, is undeniable, but no study has investigated the consequences of seroconversion to CMV without transmission of the virus to the patient fetus, or in the case of transmission without criteria of seriousness, on the patient's experience during and after her pregnancy. Such a study would, if necessary, improve the care and support of these future mothers
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults
* Referred to the 3 DAN centers with maternal seroconversion to CMV during their pregnancy, confirmed, with or without confirmed prenatal transmission.
* Presence of ultrasound signs without criteria of seriousness if the materno-fetal infection is proven.
* Support between January 1, 2008 and December 31, 2020.
* No opposition from patient
Exclusion Criteria:
* Reversed or anteconceptional CMV seroconversion
* Concomitant infection with another infectious agent and suspected cross-reaction
* Multiple pregnancy
* Ultrasound and / or MRI severity criteria
* Medical termination of pregnancy
* Fetal death in utero
* Birth \<32 weeks and / or birth weight \<1500 grams (birth criteria in maternity level IIA)
* Intercurrent event that may be the cause of an abnormality in psychomotor development
* Patients protected by justice
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.