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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A00250-51 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| SAINBIOSE | UNKNOWN |
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The nanoparticles (NP) are defined as particles whose size is no greater than 100 nanometers. However, their impact on health remains little evaluated.
Placental transfer of NP has been proven in many studies in vitro and in vivo in animals, and toxicity in the fetus has been studied in many animals. The investigators seem interesting at first to establish the mineralogical load in the amniotic fluid in humans.
The first objective of this study is to determine the mineralogical NP load, quantity and composition, in the amniotic fluid in pregnant women.
The analysis will be done on 100 amniotic fluid samples and 100 blood samples. Particle size analysis will be performed by a technique of dynamic light scattering, which permits the distribution by volume or by number of NP according to their size. Parallel to the different chemical species present in the sample must be measured by atomic emission spectrometry with inductively coupled plasma.
The results of this study will be useful for further studies on the fetal toxicity of NP in humans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pregnant woman | Patient to receive an amniocentesis for medical reasons other than study and who will have a measure of nanoparticles load |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nanoparticles load | Procedure | Pregnant women will have a sampling of amniotic fluid to measure load and composition of nanoparticles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of nanoparticles in amniotic fluid (%) | Percentage of each mineralogical Nanoparticle present in the amniotic fluid | day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of nanoparticles in blood | Percentage of each mineralogical Nanoparticle present in maternal blood | day 1 |
| Correlation Nanoparticles between blood and amniotic fluid | Establish a correlation between the mineralogical NP load in amniotic fluid and maternal blood. |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant women who receive an amniocentesis for medical reasons other than study
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| Name | Affiliation | Role |
|---|---|---|
| Celine CHAULEUR, PhD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Saint-Etienne | Saint-Etienne | 42055 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32142960 | Derived | Raia-Barjat T, Prieux C, Leclerc L, Sarry G, Grimal L, Chauleur C, Pourchez J, Forest V. Elemental fingerprint of human amniotic fluids and relationship with potential sources of maternal exposure. J Trace Elem Med Biol. 2020 Jul;60:126477. doi: 10.1016/j.jtemb.2020.126477. Epub 2020 Feb 27. |
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amniotic fluid
| day 1 |