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

Intrauterine Fetal Death Clinical Trial

— EMIBICI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03214328
• Other study ID #: 2014/209/HP
• Status: Recruiting
• Start date: November 21, 2019
• Est. completion date: November 2023

Study information

• Verified date: June 2020
• Source: University Hospital, Rouen
• Contact: Eric VERSPYCK, Pr
• Phone: +3323288
• Email: eric.verspyck[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 Retrospective cohort unpublished data on IUFD from Lille and Caen have reported exceptional deaths attributable to chromosomal or malformation abnormalities.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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 602
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Death
• Fetal Death
• Intrauterine Fetal Death
• Stillbirth

Intervention

Diagnostic Test:
• Determination of causes of fetal death
Determination of causes of fetal death using systematic protocol testing

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance of the causes of fetal death between selective and systematic protocol testing		an average of 6 months from fetal death