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

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 Retrospective cohort unpublished data on IUFD from Lille and Caen have reported exceptional deaths attributable to chromosomal or malformation abnormalities.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

Study Overview

• Status: Recruiting
• Conditions: Intrauterine Fetal Death
• Intervention / Treatment: Diagnostic test: Determination of causes of fetal death

• Study Type: Observational
• Enrollment (Anticipated): 602

Contacts and Locations

• Study Contact: Name: Eric VERSPYCK, Pr; Phone Number: 8265 +3323288; Email: eric.verspyck@chu-rouen.fr

Study Locations

• France
  • Rouen, France
    • Recruiting
    • Rouen University Hospital
    • Contact: Eric VERSPYCK, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

women underwent MFIU

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Determination of causes of fetal death; Both the extensive and selective protocols will be applied to each case of IUFD recruited, so that each case will serve as its own control. For each case, determination of cause from either protocol will be performed in a blind manner with respect to the other protocol.	Diagnostic test: Determination of causes of fetal death; Determination of causes of fetal death using systematic protocol testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Concordance of the causes of fetal death between selective and systematic protocol testing	an average of 6 months from fetal death

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Eric VERSPYCK, Pr, Rouen University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2019
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: July 7, 2017
• First Submitted That Met QC Criteria: July 10, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Actual): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 26, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Death; Fetal Death; Stillbirth
• Other Study ID Numbers: 2014/209/HP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No