Presence of Nanoparticles in the Amniotic Fluid

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Single-center Prospective Descriptive Study Evaluating the Presence of Nanoparticles in the Amniotic Fluid in Pregnant Women

Conditions
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Intrauterine Disorder

Intervention / Treatment
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* Procedure: Nanoparticles load


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient major Patient to receive an amniocentesis for medical reasons other than study (serum marker of the first quarter with an increased risk of trisomy 21 greater than 1/250, amniodrainage, sonographic sign of call) Patient who have given their free, informed and signed Exclusion Criteria: Inability to make withdrawals

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pregnant woman<br>Patient to receive an amniocentesis for medical reasons other than study and who will have a measure of nanoparticles load | Procedure: Nanoparticles load<br>* Pregnant women will have a sampling of amniotic fluid to measure load and composition of nanoparticles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of nanoparticles in amniotic fluid (%) | Percentage of each mineralogical Nanoparticle present in the amniotic fluid | day 1 | 

Secondary Outcome Measures

| Outcome Measure | 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. | day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnant women, nanoparticles, amniotic fluid