Presence of Nanoparticles in the Amniotic Fluid (NAMIOTIC)

September 27, 2018 updated by: Centre Hospitalier Universitaire de Saint Etienne

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • St Etienne, France, 42055
        • CHU Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women who receive an amniocentesis for medical reasons other than study

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
pregnant woman
Patient to receive an amniocentesis for medical reasons other than study and who will have a measure of nanoparticles load
Procedure: Nanoparticles load
Pregnant women will have a sampling of amniotic fluid to measure load and composition of nanoparticles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of nanoparticles in amniotic fluid (%)
Time Frame: day 1
Percentage of each mineralogical Nanoparticle present in the amniotic fluid
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of nanoparticles in blood
Time Frame: day 1
Percentage of each mineralogical Nanoparticle present in maternal blood
day 1
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.
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

SAINBIOSE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2016

Primary Completion (ACTUAL)

April 13, 2018

Study Completion (ACTUAL)

April 13, 2018

Study Registration Dates

First Submitted

March 11, 2016

First Submitted That Met QC Criteria

March 25, 2016

First Posted (ESTIMATE)

March 28, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 28, 2018

Last Update Submitted That Met QC Criteria

September 27, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1608016
  • 2016-A00250-51 (OTHER: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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