Spontaneous Intra Uterine Fetal DeathCOMPERNCT02148055
Comparative Evaluation of IRM and Autopsy in the Evaluation of Intra Uterine Fetal Death
A study testing Comparaison between MR and autopsy in the macroscopic evaluation of intra uterine death. in people with Spontaneous Intra Uterine Fetal Death, run by University Hospital, Rouen at 1 site in France.
Trial summary
Fetal intra uterine death is a rare event (incidence 2/1000 births) , unexpected and psychologically painful for the couple and the healthcare team. In this difficult context, it is essential to understand the etiology of death to guide the management of subsequent pregnancies. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Spontaneous Intra Uterine Fetal Death
- What is being tested?
- Comparaison between MR and autopsy in the macroscopic evaluation of intra uterine death.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to Dec 2016
- Phase
- Interventional
- 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
Who may be able to join
- Patient for which he was diagnosed with intra uterine death confirmed by ultrasound
- Mono fetal pregnancy,
- Term: 24 to 42 weeks' gestation
- Age> 18 years
- Patient having readen the letter of information and signed the consent.
Who cannot join
- Contraindication to MRI (heart valve, pacemaker, neurosurgical clips, claustrophobia, intraocular metallic foreign bodies)
- Maternal complications: bleeding during, eclampsia, placental hematoma retro, imminent work
- Twin pregnancy
- Patient under guardianship or trusteeship
- Patient not speaking and writing French
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of IRM and Autopsy in the Evaluation of Intra Uterine Fetal Death.
Fetal intra uterine death is a rare event (incidence 2/1000 births) , unexpected and psychologically painful for the couple and the healthcare team. In this difficult context, it is essential to understand the etiology of death to guide the management of subsequent pregnancies. Among the investigations, foetopathologic examination is essential, but the examination of the brain is not possible in more than half of the cases due to the cerebral maceration due to the incompressible delay between death and expulsion.
The use of MRI as a diagnostic tool fetal post- mortem " virtual autopsy " performed before expulsion of the fetus is interesting because it would permit to obtain a macroscopic examination of the fetal brain, archivable, and a gain concerning the diagnosis. Thus, a normal MRI will exclude cerebral anatomical abnormality , stroke or bleeding . If MRI abnormalities are found , it will not only guide the foetopathologic review, but mainly to guide the etiology . On the other hand , it is a non-invasive tool and acceptability by the couple would be better than autopsy which is often refused by the couple in this difficult psychological context.
In this study , MRI will be given in addition to conventional autopsy in the painful waiting time between the time of diagnosis of death and expulsion without delaying care . If this study is validated , MRI may be systematically proposed in this indication or alternative to autopsy when it will be refused by the parents.
- Conditions
- Spontaneous Intra Uterine Fetal Death
- Being tested
- Comparaison between MR and autopsy in the macroscopic evaluation of intra uterine death.
- Keywords
- spontaneous intrauterine death, fetal MRI, autopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparaison between MR and autopsy in the macroscopic evaluation of intra uterine death.Other
| Study group | Role | What they receive |
|---|---|---|
| A group of 20 pregnant patients. | Other | 20 patients referred for intrauterine spontaneous fetal death explored by MRI and autopsy. Receives: Other: Comparaison between MR and autopsy in the macroscopic evaluation of intra uterine death. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recognition of anatomic cerebral structures evaluated by a common grid.
Measured: Before H 24 for MR. Bedore day 5 for autopsy.
Secondary outcomes (3)
Recognition and mesurement of anatomic thoracic and abdominal structures by a common grid.
Measured: Before H24 for MR. Before day 5 for autopsy.
Recognition and mesurement of the placenta and umbilical cord.
Measured: Before H24 for IRM. Before day 5 for autopsy.
Comparaison of quality criteria of both exams.
Measured: Before H24 for MRI. Before day 5 for autopsy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous Intra Uterine Fetal DeathStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148055
- Sponsor's protocol ID
- 2012/169/HP
- Acronym
- COMPER
- Status last verified
- Jun 2017
- First submitted
- 22 May 2014
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of IRM and Autopsy in the Evaluation of Intra Uterine Fetal Death.
- ClinicalTrials.gov ID
- NCT02148055
- Acronym / sponsor ID
- COMPER / 2012/169/HP
- Conditions
- Spontaneous Intra Uterine Fetal Death
- Keywords
- spontaneous intrauterine death, fetal MRI, autopsy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 28 May 2014 (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.
Fetal intra uterine death is a rare event (incidence 2/1000 births) , unexpected and psychologically painful for the couple and the healthcare team. In this difficult context, it is essential to understand the etiology of death to guide the management of subsequent pregnancies. Among the investigations, foetopathologic examination is essential, but the examination of the brain is not possible in more than half of the cases due to the cerebral maceration due to the incompressible delay between death and expulsion.
The use of MRI as a diagnostic tool fetal post- mortem " virtual autopsy " performed before expulsion of the fetus is interesting because it would permit to obtain a macroscopic examination of the fetal brain, archivable, and a gain concerning the diagnosis. Thus, a normal MRI will exclude cerebral anatomical abnormality , stroke or bleeding . If MRI abnormalities are found , it will not only guide the foetopathologic review, but mainly to guide the etiology . On the other hand , it is a non-invasive tool and acceptability by the couple would be better than autopsy which is often refused by the couple in this difficult psychological context.
In this study , MRI will be given in addition to conventional autopsy in the painful waiting time between the time of diagnosis of death and expulsion without delaying care . If this study is validated , MRI may be systematically proposed in this indication or alternative to autopsy when it will be refused by the parents.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A group of 20 pregnant patients. | Other | Other: Comparaison between MR and autopsy in the macroscopic evaluation of intra uterine death.20 patients referred for intrauterine spontaneous fetal death explored by MRI and autopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient for which he was diagnosed with intra uterine death confirmed by ultrasound
- Mono fetal pregnancy,
- Term: 24 to 42 weeks' gestation
- Age> 18 years
- Patient having readen the letter of information and signed the consent.
Key exclusion criteria (5 listed)
- Contraindication to MRI (heart valve, pacemaker, neurosurgical clips, claustrophobia, intraocular metallic foreign bodies)
- Maternal complications: bleeding during, eclampsia, placental hematoma retro, imminent work
- Twin pregnancy
- Patient under guardianship or trusteeship
- Patient not speaking and writing French
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 |
|---|---|---|
| Comparaison between MR and autopsy in the macroscopic evaluation of intra uterine death. | Other | A group of 20 pregnant patients. |
Primary outcome
Recognition of anatomic cerebral structures evaluated by a common grid.
Time frame: Before H 24 for MR. Bedore day 5 for autopsy.
3 secondary outcomes
Recognition and mesurement of anatomic thoracic and abdominal structures by a common grid.
Time frame: Before H24 for MR. Before day 5 for autopsy.
Recognition and mesurement of the placenta and umbilical cord.
Time frame: Before H24 for IRM. Before day 5 for autopsy.
Comparaison of quality criteria of both exams.
Time frame: Before H24 for MRI. Before day 5 for autopsy.
Results and safety
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparaison between MR and autopsy in the macroscopic evaluation of intra uterine death. in people with Spontaneous Intra Uterine Fetal Death, run by University Hospital, Rouen at 1 site 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 5 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: stopped early, as of the sponsor's last update on 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: lack of recruitment). Results are not available in the source record.
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?
Recognition of anatomic cerebral structures evaluated by a common grid. (time frame: Before H 24 for MR. Bedore day 5 for autopsy.). 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 15 Jun 2017.