Presence of Nanoparticles in the Amniotic Fluid
NAMIOTIC
Single-center Prospective Descriptive Study Evaluating the Presence of Nanoparticles in the Amniotic Fluid in Pregnant Women
2 other identifiers
observational
95
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2016
CompletedFirst Posted
Study publicly available on registry
March 28, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 13, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 13, 2018
CompletedSeptember 28, 2018
September 1, 2018
1.9 years
March 11, 2016
September 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of nanoparticles in amniotic fluid (%)
Percentage of each mineralogical Nanoparticle present in the amniotic fluid
day 1
Secondary Outcomes (2)
Percentage of nanoparticles in blood
day 1
Correlation Nanoparticles between blood and amniotic fluid
day 1
Study Arms (1)
pregnant woman
Patient to receive an amniocentesis for medical reasons other than study and who will have a measure of nanoparticles load
Interventions
Pregnant women will have a sampling of amniotic fluid to measure load and composition of nanoparticles.
Eligibility Criteria
Pregnant women who receive an amniocentesis for medical reasons other than study
You may qualify if:
- 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
You may not qualify if:
- Inability to make withdrawals
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Hospitalier Universitaire de Saint Etiennelead
- SAINBIOSEcollaborator
Study Sites (1)
Chu Saint-Etienne
Saint-Etienne, 42055, France
Related Publications (1)
Raia-Barjat T, Prieux C, Leclerc L, Sarry G, Grimal L, Chauleur C, Pourchez J, Forest V. Elemental fingerprint of human amniotic fluids and relationship with potential sources of maternal exposure. J Trace Elem Med Biol. 2020 Jul;60:126477. doi: 10.1016/j.jtemb.2020.126477. Epub 2020 Feb 27.
PMID: 32142960DERIVED
Biospecimen
amniotic fluid
Study Officials
- PRINCIPAL INVESTIGATOR
Celine CHAULEUR, PhD
CHU SAINT-ETIENNE
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2016
First Posted
March 28, 2016
Study Start
June 1, 2016
Primary Completion
April 13, 2018
Study Completion
April 13, 2018
Last Updated
September 28, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share