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OpenTrials
Completed

NCT Number: NCT02720887

Presence of Nanoparticles in the Amniotic Fluid

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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Key information

Conditions

Intrauterine Disorder

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Chu Saint-Etienne

Saint-Etienne, 42055, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nanoparticles load

Procedure

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

Primary outcomes

  1. Percentage of nanoparticles in amniotic fluid (%)

    Time frame: day 1

    Percentage of each mineralogical Nanoparticle present in the amniotic fluid

Secondary outcomes

  1. Percentage of nanoparticles in blood

    Time frame: day 1

    Percentage of each mineralogical Nanoparticle present in maternal blood

  2. Correlation Nanoparticles between blood and amniotic fluid

    Time frame: day 1

    Establish a correlation between the mineralogical NP load in amniotic fluid and maternal blood.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • SAINBIOSE

Registry information

Official study title

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

Acronym: NAMIOTIC

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 28, 2016
Registry last updated
Sep 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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