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

NCT ID: NCT03214328

Last Updated: 2020-06-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 602 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-21
• Study Completion Date: 2023-11-30

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 Retrospective cohort unpublished data on IUFD from Lille and Caen have reported exceptional deaths attributable to chromosomal or malformation abnormalities.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

Conditions

Intrauterine Fetal Death

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Determination of causes of fetal death

Intervention Type: DIAGNOSTIC_TEST

Determination of causes of fetal death using systematic protocol testing

Interventions

Determination of causes of fetal death

Determination of causes of fetal death using systematic protocol testing

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric VERSPYCK, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

Rouen University Hospital

Rouen, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Eric VERSPYCK, Pr

Role: CONTACT

eric.verspyck@chu-rouen.fr

+3323288 ext. 8265

Julien BLOT

Role: CONTACT

julien.blot@chu-rouen.fr

+3323288 ext. 8265

Facility Contacts

Eric VERSPYCK, Pr

Role: primary

Other Identifiers

2014/209/HP

Identifier Type: -

Identifier Source: org_study_id