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

Pregnancy Related Clinical Trial

— PTSD CMV  

Official title:

Assessment of Post-traumatic Stress Disorder (PTSD) in Patients Monitored for Cytomegalovirus (CMV) Seroconversion During Pregnancy, Without Ultrasound Signs or With Non-serious Ultrasound Signs of Maternal-fetal CMV Infection.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04658810
• Other study ID #: 69HCL20_1014
• Status: Completed
• Start date: May 2, 2021
• Est. completion date: August 2, 2021

Study information

• Verified date: February 2024
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: August 2, 2021
• Est. primary completion date: August 2, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cytomegalovirus Infections
• Infections
• Mothers
• Pregnancy Related
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	Service de Gynécologie Obstétrique, Hôpital Mère Enfant	Lyon
France	Service de Gynécologie Obstétrique, Hôpital Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD evaluation	Assessment of post-traumatic stress disorder using the Perinatal Post-traumatic Stress Disorder scale (PPQ questionnaire)	Through study completion, 3 months