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

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Recruiting

CT.gov ID

NCT04658810

Collaborator

(none)

135

Enrollment

Locations

Anticipated Duration (Months)

67.5

Patients Per Site

22.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Mothers Cytomegalovirus Infections Pregnancy Related	Other: Assessment of post-traumatic stress disorder using the Perinatal Post-traumatic Stress Disorder)

Study Design

Study Type:

Observational

Anticipated Enrollment :

135 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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.

Actual Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Apr 1, 2021

Anticipated Study Completion Date :

Apr 1, 2021

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service de Gynécologie Obstétrique, Hôpital Mère Enfant	Lyon		France	69500
2	Service de Gynécologie Obstétrique, Hôpital Lyon Sud	Pierre-Bénite		France	69310