Presence of Nanoparticles in the Amniotic Fluid

Intrauterine Disorder Clinical Trial

— NAMIOTIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02720887
• Other study ID #: 1608016
• Secondary ID: 2016-A00250-51
• Status: Completed
• Start date: June 1, 2016
• Est. completion date: April 13, 2018

Study information

• Verified date: September 2018
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: April 13, 2018
• Est. primary completion date: April 13, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Intrauterine Disorder

Intervention

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

Locations

Country	Name	City	State
France	Chu Saint-Etienne	St Etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	SAINBIOSE

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of nanoparticles in amniotic fluid (%)	Percentage of each mineralogical Nanoparticle present in the amniotic fluid	day 1
Secondary	Percentage of nanoparticles in blood	Percentage of each mineralogical Nanoparticle present in maternal blood	day 1
Secondary	Correlation Nanoparticles between blood and amniotic fluid	Establish a correlation between the mineralogical NP load in amniotic fluid and maternal blood.	day 1