Intrauterine Fetal DeathEMIBICINCT03214328
Causes of Fetal Death: Comparison of Diagnostic Accuracy Between Extensive and Selective Protocol Testing
An observational study of Intrauterine Fetal Death, run by University Hospital, Rouen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Intrauterine Fetal Death
- What is being tested?
- Determination of causes of fetal death
- How many people
- 451 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2019to 6 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: women underwent MFIU
Who may be able to join
- Singleton fetus
- Intrauterine fetal death diagnosed antepartum
- Gestational age > 22 weeks
- Woman informed
- No women aged under 18 years
Who cannot join
- Pregnancy termination
- Intrapartum death
- Person placed under judicial protection, guardianship
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Determination of causes of fetal death
- Medical subject headings
- Stillbirth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determination of causes of fetal deathDiagnostic test
Determination of causes of fetal death using systematic protocol testing
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Determination of causes of fetal death |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance of the causes of fetal death between selective and systematic protocol testing
Measured: an average of 6 months from fetal death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start21 Nov 2019
- Primary completion6 Jun 2025
- Study completion6 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine Fetal DeathStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric VERSPYCK, Pr, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214328
- Sponsor's protocol ID
- 2014/209/HP
- Acronym
- EMIBICI
- Status last verified
- Nov 2026
- First submitted
- 7 Jul 2017
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Causes of Fetal Death: Comparison of Diagnostic Accuracy Between Extensive and Selective Protocol Testing
- ClinicalTrials.gov ID
- NCT03214328
- Acronym / sponsor ID
- EMIBICI / 2014/209/HP
- Conditions
- Intrauterine Fetal Death
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 6 Jun 2025 (actual)
- Study completion
- 6 Jun 2025 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Determination of causes of fetal death | – | Diagnostic Test: Determination of causes of fetal deathBoth 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- women underwent MFIU
Key inclusion criteria (5 listed)
- Singleton fetus
- Intrauterine fetal death diagnosed antepartum
- Gestational age > 22 weeks
- Woman informed
- No women aged under 18 years
Key exclusion criteria (3 listed)
- Pregnancy termination
- Intrapartum death
- Person placed under judicial protection, guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Determination of causes of fetal deathDetermination of causes of fetal death using systematic protocol testing | Diagnostic test | Determination of causes of fetal death |
Primary outcome
Concordance of the causes of fetal death between selective and systematic protocol testing
Time frame: an average of 6 months from fetal death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric VERSPYCK, Pr principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrauterine Fetal Death, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance of the causes of fetal death between selective and systematic protocol testing (time frame: an average of 6 months from fetal death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.