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Causes of Fetal Death: Comparison of Diagnostic Accuracy Between Extensive and Selective Protocol Testing

Causes of Fetal Death: Comparison of Diagnostic Accuracy Between Extensive and Selective Protocol Testing

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03214328
Acronym
EMIBICI
Enrollment
602
Registered
2017-07-11
Start date
2019-11-21
Completion date
2023-11-30
Last updated
2020-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrauterine Fetal Death

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 (6-7 per 1000 births). Optimal diagnostic evaluation for cases of IUFD is generally based on extensive protocol testing i.e. maternal and fetal blood tests, fetal bacteriology, cytogenetic analysis, autopsy, and placental examination. This extensive protocol testing may vary in clinical practice and interpretation of the results is rarely performed by multidisciplinary staff to establish cause of death. These findings are related to the fact that there 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 the Netherlands has concluded that extensive protocol testing should be redefined and some diagnostics tests may only be performed with suggestive clinical circumstances. However these recommendations may not be applicable to all populations and countries. To date, there are no French published series on IUFD to evaluate causes of death in France and thereafter to better define optimal diagnostic evaluation tests. Improvement in prenatal diagnosis in France may contribute to detection of the vast majority of severe chromosomal abnormalities and malformed fetuses and particularly those at risk of death. Retrospective cohort unpublished data on IUFD from Lille and Caen have reported exceptional deaths attributable to chromosomal or malformation abnormalities. In fact in these two series, most 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 risk situations can be as efficient.

Interventions

DIAGNOSTIC_TESTDetermination of causes of fetal death

Determination of causes of fetal death using systematic protocol testing

Sponsors

University Hospital, Rouen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* Singleton fetus * Intrauterine fetal death diagnosed antepartum * Gestational age \> 22 weeks * Woman informed * No women aged under 18 years

Exclusion criteria

* Pregnancy termination * Intrapartum death * Person placed under judicial protection, guardianship

Design outcomes

Primary

MeasureTime frame
Concordance of the causes of fetal death between selective and systematic protocol testingan average of 6 months from fetal death

Countries

France

Contacts

Primary ContactEric VERSPYCK, Pr
eric.verspyck@chu-rouen.fr+3323288
Backup ContactJulien BLOT
julien.blot@chu-rouen.fr+3323288

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026