METAHCN
Pathogen Detection by Metatranscriptomic Next Generation Sequencing in the Trophoblast Collected in Women Carrying a Fetus With Increasing Nuchal Translucency in the First Trimester of Pregnancy
Sponsor study identifier
observational
78
1 country
1
Study Start
November 7, 2022
Actual (reported)Primary Completion
April 3, 2025
Actual (reported)Study Completion
September 30, 2025
Actual (reported)The study is based on the hypothesis that increased nuchal translucency may be associated with a materno fetal infection and that the pathogen responsible for this infection could be identify with metatranscriptomic next-generation sequencing in the trophoblast tissue.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2, 2022
Actual (reported)May 24, 2022
Actual (reported)November 7, 2022
Actual (reported)April 3, 2025
Actual (reported)September 30, 2025
Actual (reported)microorganisms (viruses, bacteria, or parasites) in trophoblast samples
Identification by metatranscriptomic NGS, from women carrying a fetus with nuchal translucency (group 1) and in controls (group 2 and 3)
At inclusion, 11-14 weeks of pregnancy
Miscarriage
at termination of pregnancy (assessed up to 7 months)
intrauterine death
at termination of pregnancy (assessed up to 7 months)
fetal abnormalities
at delivery
Gestational age
at delivery
birth weight
at delivery
Pregnant women between 11 and 14 weeks with a fetus showing a nuchal translucency \> 3.5 mm and no genetic abnormalities with array CGH.
Pregnant women between 11 and 14 weeks with a fetus showing a nuchal translucency \> 3.5 mm and a genetic abnormalities at array CGH.
Pregnant women between 11 and 14 weeks with a fetus showing a nuchal translucency \< 3.5 mm and a suspicion of genetic abnormalities
Analysis with metatranscriptomic next generation sequencing of trophoblast obtained by chorionic villi sampling
Pregnant women consulting in the prenatal diagnosis Unit of the University Hospital Necker-Enfants-malades
Hopital Necker - Enfants malades
Paris, 75015, France
Sebire NJ, Bianco D, Snijders RJ, Zuckerman M, Nicolaides KH. Increased fetal nuchal translucency thickness at 10-14 weeks: is screening for maternal-fetal infection necessary? Br J Obstet Gynaecol. 1997 Feb;104(2):212-5. doi: 10.1111/j.1471-0528.1997.tb11047.x.
Faure-Bardon V, Fourgeaud J, Guilleminot T, Magny JF, Salomon LJ, Bernard JP, Leruez-Ville M, Ville Y. First-trimester diagnosis of congenital cytomegalovirus infection after maternal primary infection in early pregnancy: feasibility study of viral genome amplification by PCR on chorionic villi obtained by CVS. Ultrasound Obstet Gynecol. 2021 Apr;57(4):568-572. doi: 10.1002/uog.23608. Epub 2021 Mar 9.
Marianne LERUEZ-VILLE, MD, PhD
Assistance Publique - Hôpitaux de Paris
Yves Ville, MD, PhD
Assistance Publique - Hôpitaux de Paris
78 participants (actual enrollment reported by the registry).
First Submitted
May 2, 2022
First Posted
May 24, 2022
Study Start
November 7, 2022
Actual (reported)If a microorganism is detected by metatranscriptomic NGS, specific diagnosis (PCR and serology) will be done in maternal and neonatal samples (blood, urine, saliva)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Regnault B, Bigot T, Ma L, Perot P, Temmam S, Eloit M. Deep Impact of Random Amplification and Library Construction Methods on Viral Metagenomics Results. Viruses. 2021 Feb 7;13(2):253. doi: 10.3390/v13020253.
Bilardo CM, Timmerman E, Pajkrt E, van Maarle M. Increased nuchal translucency in euploid fetuses--what should we be telling the parents? Prenat Diagn. 2010 Feb;30(2):93-102. doi: 10.1002/pd.2396.
Primary Completion
April 3, 2025
Actual (reported)Study Completion
September 30, 2025
Actual (reported)Last Updated
June 24, 2026
Record last verified: 2026-06
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Source: ClinicalTrials.gov.
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