Presence of Nanoparticles in the Amniotic Fluid

Completed

• Conditions: Intrauterine Disorder
• Interventions: Procedure: Nanoparticles load

• Registration Number: NCT02720887
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-03-11
• Study First Submitted QC: 2016-03-25
• Study First Posted: 2016-03-28
• Study Start: 2016-06-01
• Primary Completion: 2018-04-13
• Study Completion: 2018-04-13
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-27
• Last Update Posted: 2018-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 95

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pregnant woman	Nanoparticles load	Patient to receive an amniocentesis for medical reasons other than study and who will have a measure of nanoparticles load

Primary Outcome Measures

Name	Time	Method
Percentage of nanoparticles in amniotic fluid (%)	day 1	Percentage of each mineralogical Nanoparticle present in the amniotic fluid

Secondary Outcome Measures

Name	Time	Method
Percentage of nanoparticles in blood	day 1	Percentage of each mineralogical Nanoparticle present in maternal blood
Correlation Nanoparticles between blood and amniotic fluid	day 1	Establish a correlation between the mineralogical NP load in amniotic fluid and maternal blood.

Trial Locations

Locations (1)

Chu Saint-Etienne; 🇫🇷 St Etienne, France