Neural Tube Defects (NTDs)BIMASNCT07864142
First-Trimester Screening of Open Neural Tube Defects Using Biometrics and Maternal Serum Markers
An observational study of Neural Tube Defects (NTDs), run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Open neural tube defects are congenital malformations associated with significant morbidity. Early detection during the first trimester remains a key challenge. This retrospective monocentric study aims to evaluate the diagnostic performance of fetal biometrics (biparietal diameter and abdominal transverse diameter… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Neural Tube Defects (NTDs)
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 14 Sep 2026to 14 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women undergoing routine first-trimester ultrasound screening at Strasbourg University Hospitals, including both normal pregnancies and those complicated by open neural tube defects.
Who may be able to join
- Adult pregnant woman (≥18 years)
- First-trimester ultrasound performed at Strasbourg University Hospitals between 01/01/2011 and 31/12/2023
- No written opposition to reuse of medical data for research purposes
Who cannot join
- Written opposition to reuse of medical data for research purposes
- Multiple pregnancy
- Presence of fetal growth abnormality, morphological or genetic anomaly during pregnancy
- Crown-rump length <45 mm or >84 mm at screening ultrasound
- Missing data
- Fetus with closed dysraphism
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Gynécologie et Obstétrique - CHU de Strasbourg - France
Strasbourg, 67091
Chris Minella, MD, 33 3 88 12 74 95, chris.minella@chru-strasbourg.fr
Chris Minella, MD
About this study
Official title: Analysis of Fetal Biometrics and Maternal Serum Markers in First-Trimester Screening of Open Neural Tube Defects
Open neural tube defects are congenital malformations associated with significant morbidity. Early detection during the first trimester remains a key challenge.
This retrospective monocentric study aims to evaluate the diagnostic performance of fetal biometrics (biparietal diameter and abdominal transverse diameter ratios) and maternal serum markers (beta-hCG and PAPP-A) for early screening of open neural tube defects. The study will assess the predictive value of these parameters individually and in combination to define optimal screening thresholds applicable in routine clinical practice
- Conditions
- Neural Tube Defects (NTDs)
- Keywords
- Neural tube defects, Prenatal screening, First trimester, Fetal biometrics, Maternal serum markers
- Medical subject headings
- Neural Tube Defects
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of biometric ratios and serum markers
Determination of optimal thresholds for BPD/TAD and BPD/PA ratios and maternal serum markers (beta-hCG and PAPP-A) for screening of open neural tube defects, by comparing their diagnostic performance alone and in combination using ROC analysis.
Measured: At first-trimester screening (retrospective data from 2011 to 2023)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start14 Sep 2026
- Primary completion14 Nov 2026 (estimated)
- Study completion14 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neural Tube Defects (NTDs)Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864142
- Sponsor's protocol ID
- RC26_0313
- Acronym
- BIMAS
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Fetal Biometrics and Maternal Serum Markers in First-Trimester Screening of Open Neural Tube Defects
- ClinicalTrials.gov ID
- NCT07864142
- Acronym / sponsor ID
- BIMAS / RC26_0313
- Conditions
- Neural Tube Defects (NTDs)
- Keywords
- Neural tube defects, Prenatal screening, First trimester, Fetal biometrics, Maternal serum markers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 14 Sep 2026 (actual)
- Primary completion
- 14 Nov 2026 (estimated)
- Study completion
- 14 Dec 2026 (estimated)
- First posted
- 7 Oct 2026 (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.
Open neural tube defects are congenital malformations associated with significant morbidity. Early detection during the first trimester remains a key challenge.
This retrospective monocentric study aims to evaluate the diagnostic performance of fetal biometrics (biparietal diameter and abdominal transverse diameter ratios) and maternal serum markers (beta-hCG and PAPP-A) for early screening of open neural tube defects. The study will assess the predictive value of these parameters individually and in combination to define optimal screening thresholds applicable in routine clinical practice
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women undergoing routine first-trimester ultrasound screening at Strasbourg University Hospitals, including both normal pregnancies and those complicated by open neural tube defects.
Key inclusion criteria (3 listed)
- Adult pregnant woman (≥18 years)
- First-trimester ultrasound performed at Strasbourg University Hospitals between 01/01/2011 and 31/12/2023
- No written opposition to reuse of medical data for research purposes
Key exclusion criteria (6 listed)
- Written opposition to reuse of medical data for research purposes
- Multiple pregnancy
- Presence of fetal growth abnormality, morphological or genetic anomaly during pregnancy
- Crown-rump length <45 mm or >84 mm at screening ultrasound
- Missing data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic performance of biometric ratios and serum markers
Time frame: At first-trimester screening (retrospective data from 2011 to 2023)
Determination of optimal thresholds for BPD/TAD and BPD/PA ratios and maternal serum markers (beta-hCG and PAPP-A) for screening of open neural tube defects, by comparing their diagnostic performance alone and in combination using ROC analysis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
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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.
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 Neural Tube Defects (NTDs), run by University Hospital, Strasbourg, France 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 7 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chris Minella, MD (33 3 88 12 74 95, chris.minella@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of biometric ratios and serum markers (time frame: At first-trimester screening (retrospective data from 2011 to 2023)). 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 7 Oct 2026.