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

NCT04658810 | Completed

• 1 other identifier: 69HCL20_1014
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 2

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

Conditions

Mothers; Cytomegalovirus Infections; Pregnancy Related

Keywords

CMV; Pregnancy; PTSD

Outcome Measures

Primary Outcomes (1)

• PTSD evaluation

  Assessment of post-traumatic stress disorder using the Perinatal Post-traumatic Stress Disorder scale (PPQ questionnaire)

  Through study completion, 3 months

Interventions

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Service de Gynécologie Obstétrique, Hôpital Mère Enfant

Lyon, 69500, France

Location

Service de Gynécologie Obstétrique, Hôpital Lyon Sud

Pierre-Bénite, 69310, France

Location

MeSH Terms

Conditions

Cytomegalovirus Infections; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Alexis Fichez

  service de Gynécologie-Obstétrique, Hôpital de la Croix Rousse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 8, 2020
• Study Start: May 2, 2021
• Primary Completion: August 2, 2021
• Study Completion: August 2, 2021
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)