Metatranscriptomic Next Generation Sequencing in First Trimester Trophoblast With Increased Fetal Nuchal Translucency (METAHCN)
NCT ID: NCT05388968
Last Updated: 2024-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
110 participants
OBSERVATIONAL
2022-11-07
2026-02-28
Brief Summary
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Detailed Description
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The etiology of increased nuchal translucency remains unknown in more than 50% of the cases. It could be linked to inflammation or reflect an infection but this latter association has been rarely studied. This association was suggested in a study reporting serology of CMV, toxoplasmosis or B19 parvovirus primary infections in pregnant women carrying a fetus with increased nuchal translucency. In those rare cases, the microorganism was not searched directly in the trophoblast tissue. In the investigators' center, the investigators describe in a context of maternal primary infection, one case of increased nuchal translucency with a positive CMV PCR in the trophoblast tissue collected at 12 weeks. Other pathogens yet not identified might be associated with increased nuchal translucency.
Metatranscriptomic next generation sequencing (mNGS) allows to search for any pathogens without a priori. It is therefore a powerful technic to study this potential association between increased nuchal translucency and infection.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Nuchal translucency with no genetic abnormalities
Pregnant women between 11 and 14 weeks with a fetus showing a nuchal translucency \> 3.5 mm and no genetic abnormalities with array CGH.
Metatranscriptomic
Analysis with metatranscriptomic next generation sequencing of trophoblast obtained by chorionic villi sampling
Specific microbiologic diagnosis
If a microorganism is detected by metatranscriptomic NGS, specific diagnosis (PCR and serology) will be done in maternal and neonatal samples (blood, urine, saliva)
Nuchal translucency with genetic abnormalities
Pregnant women between 11 and 14 weeks with a fetus showing a nuchal translucency \> 3.5 mm and a genetic abnormalities at array CGH.
Metatranscriptomic
Analysis with metatranscriptomic next generation sequencing of trophoblast obtained by chorionic villi sampling
Specific microbiologic diagnosis
If a microorganism is detected by metatranscriptomic NGS, specific diagnosis (PCR and serology) will be done in maternal and neonatal samples (blood, urine, saliva)
Genetic abnormalities
Pregnant women between 11 and 14 weeks with a fetus showing a nuchal translucency \< 3.5 mm and a suspicion of genetic abnormalities
Metatranscriptomic
Analysis with metatranscriptomic next generation sequencing of trophoblast obtained by chorionic villi sampling
Specific microbiologic diagnosis
If a microorganism is detected by metatranscriptomic NGS, specific diagnosis (PCR and serology) will be done in maternal and neonatal samples (blood, urine, saliva)
Interventions
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Metatranscriptomic
Analysis with metatranscriptomic next generation sequencing of trophoblast obtained by chorionic villi sampling
Specific microbiologic diagnosis
If a microorganism is detected by metatranscriptomic NGS, specific diagnosis (PCR and serology) will be done in maternal and neonatal samples (blood, urine, saliva)
Eligibility Criteria
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Inclusion Criteria
* Singleton pregnancy
* First trimester (11 GA+0D to 13 GA+6D)
* Carrying a fetus with a nuchal translucency \> 3.5 mm for which a chorionic villi sampling is performed OR a suspicion of genetic abnormalities for which a chorionic villi sampling is performed
* Delivery planned at Necker hospital
* Not opposed to participation
Exclusion Criteria
* no health insurance
* difficulties in understanding the French language
* chronic infection (HIV, HBV, HVC and HTLV-1)
18 Years
FEMALE
No
Sponsors
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Pathogen Discovery Laboratory
UNKNOWN
Institut Pasteur
INDUSTRY
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Marianne LERUEZ-VILLE, MD, PhD
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux de Paris
Yves Ville, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hopital Necker - Enfants malades
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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APHP211328
Identifier Type: -
Identifier Source: org_study_id
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