Presence of Nanoparticles in the Amniotic Fluid

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

95 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-01

Study Completion Date

2018-04-13

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.

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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.

Conditions

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Intrauterine Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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pregnant woman

Patient to receive an amniocentesis for medical reasons other than study and who will have a measure of nanoparticles load

Nanoparticles load

Intervention Type PROCEDURE

Pregnant women will have a sampling of amniotic fluid to measure load and composition of nanoparticles.

Interventions

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Nanoparticles load

Pregnant women will have a sampling of amniotic fluid to measure load and composition of nanoparticles.

Intervention Type PROCEDURE

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