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

NCT03214328 | Unknown

• 1 other identifier: 2014/209/HP
• Study Type: observational
• Target: 602
• Locations: 1 country
• Sites: 1

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 Retrospective cohort unpublished data on IUFD from Lille and Caen have reported exceptional deaths attributable to chromosomal or malformation abnormalities.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

Outcome Measures

Primary Outcomes (1)

• Concordance of the causes of fetal death between selective and systematic protocol testing

  an average of 6 months from fetal death

Study Arms (1)

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

Interventions

Determination of causes of fetal death DIAGNOSTIC_TEST

Determination of causes of fetal death using systematic protocol testing

Determination of causes of fetal death

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: women underwent MFIU
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

women underwent MFIU

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, France

RECRUITING

MeSH Terms

Conditions

Stillbirth

Condition Hierarchy (Ancestors)

Fetal Death; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric VERSPYCK, Pr

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric VERSPYCK, Pr

CONTACT

+3323288; eric.verspyck@chu-rouen.fr

Julien BLOT

CONTACT

+3323288; julien.blot@chu-rouen.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 11, 2017
• Study Start: November 21, 2019
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: June 30, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)