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Presence of Nanoparticles in the Amniotic Fluid

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02720887
Acronym
NAMIOTIC
Enrollment
95
Registered
2016-03-28
Start date
2016-06-01
Completion date
2018-04-13
Last updated
2018-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrauterine Disorder

Keywords

pregnant women, nanoparticles, amniotic fluid

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.

Interventions

PROCEDURENanoparticles load

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

Sponsors

SAINBIOSE
CollaboratorUNKNOWN
Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of nanoparticles in amniotic fluid (%)day 1Percentage of each mineralogical Nanoparticle present in the amniotic fluid

Secondary

MeasureTime frameDescription
Percentage of nanoparticles in bloodday 1Percentage of each mineralogical Nanoparticle present in maternal blood
Correlation Nanoparticles between blood and amniotic fluidday 1Establish a correlation between the mineralogical NP load in amniotic fluid and maternal blood.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026