MothersPTSD CMVNCT04658810
Assessment of Post-traumatic Stress Disorder (PTSD) in Patients Monitored for Cytomegalovirus (CMV) Seroconversion During Pregnancy,
An observational study of Mothers and Cytomegalovirus Infections, run by Hospices Civils de Lyon at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mothers, Cytomegalovirus Infections, Pregnancy Related
- What is being tested?
- Assessment of post-traumatic stress disorder using the Perinatal Post-traumatic Stress Disorder)
- How many people
- 87 participants
- Where
- 2 sitesFrance
- Study dates
- 2 May 2021to 2 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Assessment of post-traumatic stress disorder using the Perinatal Post-traumatic Stress Disorder)
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service de Gynécologie Obstétrique, Hôpital Mère Enfant
Lyon, 69500
Service de Gynécologie Obstétrique, Hôpital Lyon Sud
Pierre-Bénite, 69310
About this study
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.
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
- Being tested
- Assessment of post-traumatic stress disorder using the Perinatal Post-traumatic Stress Disorder)
- Keywords
- CMV, Pregnancy, PTSD
- Medical subject headings
- Cytomegalovirus Infections, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD evaluation
Assessment of post-traumatic stress disorder using the Perinatal Post-traumatic Stress Disorder scale (PPQ questionnaire)
Measured: Through study completion, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020 (estimated)
- Study start2 May 2021
- Primary completion2 Aug 2021
- Study completion2 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MothersStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexis Fichez, Principal investigator, service de Gynécologie-Obstétrique, Hôpital de la Croix Rousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658810
- Sponsor's protocol ID
- 69HCL20_1014
- Acronym
- PTSD CMV
- Status last verified
- Feb 2024
- First submitted
- 1 Dec 2020
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04658810
- Acronym / sponsor ID
- PTSD CMV / 69HCL20_1014
- Conditions
- Mothers, Cytomegalovirus Infections, Pregnancy Related
- Keywords
- CMV, Pregnancy, PTSD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 2 May 2021 (actual)
- Primary completion
- 2 Aug 2021 (actual)
- Study completion
- 2 Aug 2021 (actual)
- First posted
- 8 Dec 2020 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Assessment of post-traumatic stress disorder using the Perinatal Post-traumatic Stress Disorder)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | – |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexis Fichez principal investigator
service de Gynécologie-Obstétrique, Hôpital de la Croix Rousse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mothers and Cytomegalovirus Infections, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD evaluation (time frame: Through study completion, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.