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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

Tracking Information
First Submitted Date  ICMJE March 20, 2019
First Posted Date  ICMJE March 21, 2019
Last Update Posted Date November 6, 2019
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date March 24, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does Elective Amniocentesis Change Vaginal Microbiome?
Official Title  ICMJE Does Elective Amniocentesis Change Vaginal Microbiome?
Brief Summary the aim of this study is to check if elective amniocentesis change vaginal microbiome
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Vaginal Microbiome
Intervention  ICMJE 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
Study Arms  ICMJE 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
Intervention: Diagnostic Test: Vaginal Microbiome as result of aminocentesis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 20, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 24, 2021
Estimated Primary Completion Date March 24, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • infection in the Uterus
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Osnat Palgi, BS.c +972-4-7744602 osnatp@hymc.gov.il
Contact: Rinat Gabbay Ben-Ziv, MD RinatG@hy.health.gov.il
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03884361
Other Study ID Numbers  ICMJE 0126-18-HYMC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hillel Yaffe Medical Center
Study Sponsor  ICMJE Hillel Yaffe Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gabbay Gabbay Ben-Ziv, MD Hillel Yaffe medical center, Hadera, Israel
PRS Account Hillel Yaffe Medical Center
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP