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Does Elective Amniocentesis Change Vaginal Microbiome?

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ClinicalTrials.gov Identifier: NCT03884361
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Study Description
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Brief Summary:
the aim of this study is to check if elective amniocentesis change vaginal microbiome

Condition or disease Intervention/treatment Phase
Vaginal Microbiome Diagnostic Test: Vaginal Microbiome as result of aminocentesis Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Does Elective Amniocentesis Change Vaginal Microbiome?
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : March 24, 2020
Estimated Study Completion Date : March 24, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Vaginal Microbiome as result of aminocentesis
aginal Microbiome as result of aminocentesis by a blood and a vaginal samples that will taken before and after the aminocentesis
 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


Outcome Measures
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Primary Outcome Measures :
  1. Vaginal Microbiome [ Time Frame: 1 year ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • infection in the Uterus
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884361


Contacts
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Contact: Osnat Palgi, BS.c +972-4-7744602 osnatp@hymc.gov.il
Contact: Rinat Gabbay Ben-Ziv, MD RinatG@hy.health.gov.il

Locations
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Israel
Hillel Yaffe medical center Recruiting
Hadera, Israel, 3810101
Contact: Osnat Palgi, Bsc    +972-4-7744602    osnatp@hymc.gov.il   
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
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Principal Investigator: Gabbay Gabbay Ben-Ziv, MD Hillel Yaffe medical center, Hadera, Israel
More Information
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Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT03884361    
Other Study ID Numbers: 0126-18-HYMC
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No