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Congenital Cytomegaly Virus Infection: correlation of Fetal MRI findings vs clinical outcome


- candidate number15378
- NTR NumberNTR4162
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-sep-2013
- Secondary IDsMieke Cannie 
- Public TitleCongenital Cytomegaly Virus Infection: correlation of Fetal MRI findings vs clinical outcome
- Scientific TitleCongenital Cytomegaly Virus Infection: correlation of Fetal MRI findings vs clinical outcome
- ACRONYMCMV
- hypothesisFetal MRI can be helpfull in detecting CMV related lesions and can help in this way the counseling of patients in the future.
- Healt Condition(s) or Problem(s) studied
- Inclusion criteria- CMV seroconversion during pregnancy
- CMV positive amniotic fluid or/and CMV positive urine neonate.
- Exclusion criteria- No signs of CMV in amniotic fluid or/and positive urine neonate.
- no postnatale follow up.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jun-2013
- planned closingdate1-jan-2014
- Target number of participants250
- Interventionssecond look fetal MRI + correlation postnatal follow up
- Primary outcomeDiagnostic accuracy of in utero MRI in case of congenital CMV
- Secondary outcomeDiagnostic agreement between antenatal US and in utero MRI in case of congenital CMV
- Timepoints1 MRI during pregnancy at least 1 clinical follow up postnataland/or autopsy findings.
- Trial web siteN/A
- statusrecruitement status not public
- CONTACT FOR PUBLIC QUERIES Mieke Cannie
- CONTACT for SCIENTIFIC QUERIES Mieke Cannie
- Sponsor/Initiator Fetal Medicine Foundation Belgium
- Funding
(Source(s) of Monetary or Material Support)
Fetal Medicine Foundation Belgium
- PublicationsN/A
- Brief summaryThe aim of the study is to improve the prenatal counselling of parents and to guide future management decisions in cases of proven cCMV infection. In particular the emphasis is on the additional contribution made by in utero MRI relative to the information already established by antenatal ultrasound, timing of CMV infection. In order to achieve this, the following measures will be analysed:
- Comparison of the diagnostic agreement between antenatal ultrasound and in utero MRI
- Quantification of the diagnostic accuracy of MRI in cases of proven cCMV infection (with reference to clinical and pathological outcome)
- Correlation of MRI findings with clinical outcome.
- Comparison between the first MRI diagnosis at the first center and the second look by a trained fetal MRI specialist.
- Main changes (audit trail)
- RECORD6-sep-2013 - 8-okt-2013


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