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NCT03884361 Clinical Trial

Does Elective Amniocentesis Change Vaginal Microbiome?

Vaginal Microbiome Clinical Trial

Official title:
Does Elective Amniocentesis Change Vaginal Microbiome?

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03884361
Other study ID # 0126-18-HYMC
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2019
Est. completion date March 24, 2021

Study information
Verified date November 2019
Source Hillel Yaffe Medical Center
Contact Osnat Palgi, BS.c
Phone +972-4-7744602
Email osnatp@hymc.gov.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

the aim of this study is to check if elective amniocentesis change vaginal microbiome

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date March 24, 2021
Est. primary completion date March 24, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- pregnant women between 18-45 years old , pregnant week is 16-24 , and a signle pregnant.

Exclusion Criteria:

- infection in the Uterus

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Vaginal Microbiome as result of aminocentesis
we will take a blood samples and a vaginale samples after and before the aminicentesis and check if the sample that we took after is different and contain microrganisms , if we find a different o we can say that as result of the Elective Amniocentesis

Locations
Country Name City State
Israel Hillel Yaffe medical center Hadera

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Vaginal Microbiome through blood and vaginal samples we will check if there are a vaginale micobiome - the samples will collected after and before the elective aminocentesis , the samples will sent to the labour of dr. Omer in the university , it will be analaysed there 1 year
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