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

Completed

• Conditions: Cytomegalovirus Infections; Pregnancy Related; Mothers

• Registration Number: NCT04658810
• Lead Sponsor: Hospices Civils de Lyon

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-01
• Study First Submitted QC: 2020-12-07
• Study First Posted: 2020-12-08
• Study Start: 2021-05-02
• Primary Completion: 2021-08-02
• Study Completion: 2021-08-02
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 87

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PTSD evaluation	Through study completion, 3 months	Assessment of post-traumatic stress disorder using the Perinatal Post-traumatic Stress Disorder scale (PPQ questionnaire)

Trial Locations

Locations (2)

Service de Gynécologie Obstétrique, Hôpital Mère Enfant; 🇫🇷 Lyon, France

Service de Gynécologie Obstétrique, Hôpital Lyon Sud; 🇫🇷 Pierre-Bénite, France