First-Trimester Screening for Open Neural Tube Defects with Fetal Biometrics and Maternal Markers
Official title: Analysis of Fetal Biometrics and Maternal Serum Markers in First-Trimester Screening of Open Neural Tube Defects
Run by University Hospital, Strasbourg, France · NCT07864142 · Data updated 2026-11-12
This study tests whether early ultrasound measures and maternal blood markers can help screen for open neural tube defects in the first trimester.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Status | Recruiting |
| Started | September 14, 2026 |
| Main results expected | November 14, 2026 |
| Study ends | December 14, 2026 |
| Registry record updated | October 7, 2026 |
| Trial ID | NCT07864142 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant adults (18+) who had a first-trimester ultrasound at Strasbourg University Hospitals between 2011 and 2023 and did not opt out of research data use.
✕Probably not a fit
Pregnancies with missing data, multiple gestations, fetal abnormalities other than open neural tube defects, or crown-rump lengths outside 45–84 mm are less likely to benefit from this screening approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This retrospective study analyzes data from first-trimester ultrasounds and maternal serum markers to see how well fetal measurements and biochemical markers predict open neural tube defects. The researchers examine each parameter alone and in combination to establish practical screening thresholds for routine care. Data come from Strasbourg University Hospitals between 2011 and 2023, focusing on singleton pregnancies with no data gaps. The goal is to identify a reliable, early screening approach that could be used in everyday obstetric practice. Findings may inform future prospective validation and potential screening guidelines.
Why it matters
Potential benefit: If successful, this approach could enable earlier, noninvasive detection of open neural tube defects in pregnancy.
How similar studies have gone: Similar biomarker-and-imaging approaches have shown promise in retrospective analyses, but application to first-trimester open neural tube defect screening remains exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where it's running
-
Service de Gynécologie et Obstétrique - CHU de Strasbourg - France
Strasbourg, France Recruiting
Study contacts
- Study coordinator: Chris Minella, MD
- Email: chris.minella@chru-strasbourg.fr
- Phone: 33 3 88 12 74 95
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Fetoscopic repair of neural tube defects
This study looks at how well a special surgery done before birth can help babies with spina bifida and what happens to them after the procedure.
-
Folic Acid–Fortified Salt for Women of Reproductive Age in Zambia
This study tests whether iodized salt fortified with folic acid can raise blood folate levels in non-pregnant, non-lactating women in Zambia who don’t have a folic acid fortification program.
-
Evaluating devices for repairing neural tube defects in fetoscopic procedures
This study is testing new tools to see if they make it safer and easier to fix neural tube defects in unborn babies during a special type of surgery.
-
Comparing two surgical methods for correcting fetal myelomeningocele
This study is testing two different surgical methods to see which one works better and is safer for fixing a serious birth defect called fetal myelomeningocele before the baby is born.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.