what diagnositc testing is used to identify fetal death
Causes of Fetal Death: Comparison of Diagnostic Accuracy Between Extensive and Selective Protocol Testing (EMIBICI)
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| ClinicalTrials.gov Identifier: NCT03214328 |
| Recruitment Status : Recruiting First Posted : July 11, 2017 Last Update Posted : June 30, 2020 |
Sponsor:
University Infirmary, Rouen
Information provided past (Responsible Party):
University Hospital, Rouen
Brief Summary:
Intrauterine fetal death (IUFD) is defined as the occurrence of fetal death at >20 weeks' gestation. IUFD affects about 1 in 160 pregnancies (vi-7 per 1000 births). Optimal diagnostic evaluation for cases of IUFD is generally based on extensive protocol testing i.e. maternal and fetal claret tests, fetal bacteriology, cytogenetic assay, dissection, and placental test. This all-encompassing protocol testing may vary in clinical practice and estimation of the results is rarely performed by multidisciplinary staff to institute cause of death. These findings are related to the fact that in that location are very few epidemiological studies to validate optimal protocol, no French recommendations on this subject, and a relative lack of pathologists with expertise in perinatal pathology. Only, one recent prospective study from kingdom of the netherlands has concluded that extensive protocol testing should be redefined and some diagnostics tests may simply be performed with suggestive clinical circumstances. However these recommendations may not be applicable to all populations and countries. To date, at that place are no French published series on IUFD to evaluate causes of death in France and thereafter to better define optimal diagnostic evaluation tests. Comeback in prenatal diagnosis in France may contribute to detection of the vast bulk of severe chromosomal abnormalities and malformed fetuses and particularly those at take chances of death. Retrospective accomplice unpublished information on IUFD from Lille and Caen have reported infrequent deaths attributable to chromosomal or malformation abnormalities. In fact in these ii series, well-nigh deaths were related to placental diseases or fetal growth retardation. The hypothesis is that extensive protocol testing is not helpful in clinical practice and selective protocol testing focused on specific run a risk situations can be as efficient.
| Condition or disease | Intervention/handling |
|---|---|
| Intrauterine Fetal Decease | Diagnostic Exam: Decision of causes of fetal death |
| Study Blazon : | Observational |
| Estimated Enrollment : | 602 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Causes of Fetal Death: Comparison of Diagnostic Accuracy Between All-encompassing and Selective Protocol Testing |
| Actual Report Start Engagement : | Nov 21, 2019 |
| Estimated Primary Completion Appointment : | November 2023 |
| Estimated Study Completion Engagement : | Nov 2023 |
Resource links provided by the National Library of Medicine 
| Grouping/Accomplice | Intervention/treatment |
|---|---|
| Determination of causes of fetal expiry Both the all-encompassing and selective protocols volition be applied to each case of IUFD recruited, so that each example will serve as its own control. For each case, determination of cause from either protocol will be performed in a blind mode with respect to the other protocol. | Diagnostic Examination: Determination of causes of fetal expiry Determination of causes of fetal death using systematic protocol testing |
Primary Result Measures :
- Concordance of the causes of fetal decease between selective and systematic protocol testing [ Time Frame: an boilerplate of 6 months from fetal death ]
Data from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 45 Years (Developed) |
| Sexes Eligible for Report: | Female person |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Clarification: | women underwent MFIU |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
women underwent MFIU
Criteria
Inclusion Criteria:
- Singleton fetus
- Intrauterine fetal death diagnosed antepartum
- Gestational age > 22 weeks
- Woman informed
- No women aged under xviii years
Exclusion Criteria:
- Pregnancy termination
- Intrapartum death
- Person placed nether judicial protection, guardianship
Information from the National Library of Medicine
To learn more virtually this report, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03214328
Contacts
Locations
| French republic | |
| Rouen University Infirmary | Recruiting |
| Rouen, France | |
| Contact: Eric VERSPYCK, Pr | |
Sponsors and Collaborators
University Infirmary, Rouen
Investigators
| Principal Investigator: | Eric VERSPYCK, Pr | Rouen University Infirmary |
| Responsible Party: | University Infirmary, Rouen |
| ClinicalTrials.gov Identifier: | NCT03214328 |
| Other Study ID Numbers: | 2014/209/HP |
| Start Posted: | July 11, 2017 Key Record Dates |
| Last Update Posted: | June xxx, 2020 |
| Concluding Verified: | June 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.Due south. FDA-regulated Drug Product: | No |
| Studies a U.Southward. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
| Fetal Death Stillbirth Death Pathologic Processes Pregnancy Complications |
Source: https://clinicaltrials.gov/ct2/show/NCT03214328
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