Identifying infections in early pregnancy with increased nuchal translucency
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
This study is trying to find out if infections in pregnant women are linked to increased nuchal translucency in their babies during the first trimester.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05388968 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the potential link between increased nuchal translucency in the first trimester of pregnancy and maternal-fetal infections. It employs metatranscriptomic next-generation sequencing to analyze trophoblast tissue from pregnant women carrying fetuses with nuchal translucency greater than 3.5 mm. The goal is to identify pathogens that may contribute to this condition, which remains unexplained in over 50% of cases. By focusing on cases where chorionic villi sampling is performed, the study aims to enhance understanding of the etiology behind increased nuchal translucency.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women in their first trimester with a singleton pregnancy and a fetus exhibiting increased nuchal translucency.
Not a fit: Patients who may not benefit from this study include those under 18 years of age, those without health insurance, or those with chronic infections.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods for identifying infections in early pregnancy, potentially reducing risks associated with unexplained increased nuchal translucency.
How similar studies have performed: While the association between increased nuchal translucency and infections has been suggested, this approach using metatranscriptomic sequencing is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women * 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 * Age \<18 years * no health insurance * difficulties in understanding the French language * chronic infection (HIV, HBV, HVC and HTLV-1)
Where this trial is running
Paris
- Hopital Necker - Enfants malades — Paris, France (Recruiting)
Study contacts
- Principal investigator: Yves Ville, MD, PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Jacques FOURGEAUD, PharmD
- Email: jacques.fourgeaud@aphp.fr
- Phone: 01 44 49 56 11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.