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

February 27, 2024 updated by: Hospices Civils de Lyon

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

87

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69500
        • Service de Gynécologie Obstétrique, Hôpital Mère Enfant
      • Pierre-Bénite, France, 69310
        • Service de Gynécologie Obstétrique, Hôpital Lyon Sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Through study completion, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Alexis Fichez, Service de Gynecologie-Obstetrique, Hopital de la Croix Rousse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2021

Primary Completion (Actual)

August 2, 2021

Study Completion (Actual)

August 2, 2021

Study Registration Dates

First Submitted

December 1, 2020

First Submitted That Met QC Criteria

December 7, 2020

First Posted (Estimated)

December 8, 2020

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL20_1014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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