Assessment of Post-traumatic Stress Disorder (PTSD) in Patients Monitored for Cytomegalovirus (CMV) Seroconversion During Pregnancy,

NCT ID: NCT04658810

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

87 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-02

Study Completion Date

2021-08-02

Brief Summary

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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

Detailed Description

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Conditions

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Mothers Cytomegalovirus Infections Pregnancy Related

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Assessment of post-traumatic stress disorder using the Perinatal Post-traumatic Stress Disorder)

Patients identified as women with cytomegalovirus (CMV) seroconversion during pregnancy will be called on the phoned and ask to participate to the study and to answer the Perinatal Post-traumatic Stress Disorder

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexis Fichez

Role: PRINCIPAL_INVESTIGATOR

service de Gynécologie-Obstétrique, Hôpital de la Croix Rousse

Locations

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Service de Gynécologie Obstétrique, Hôpital Mère Enfant

Lyon, , France

Site Status

Service de Gynécologie Obstétrique, Hôpital Lyon Sud

Pierre-Bénite, , France

Site Status

Countries

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France

Other Identifiers

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69HCL20_1014

Identifier Type: -

Identifier Source: org_study_id

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