Skip to main content
OpenTrials
Completed

NCT Number: NCT04658810

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Service de Gynécologie Obstétrique, Hôpital Mère Enfant, Lyon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. PTSD evaluation

    Time frame: Through study completion, 3 months

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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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.

Acronym: PTSD CMV

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 8, 2020
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.