Does Elective Amniocentesis Change Vaginal Microbiome?

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

Tracking Information

• First Submitted Date: March 20, 2019
• First Posted Date: March 21, 2019
• Last Update Posted Date: November 6, 2019
• Actual Study Start Date: April 1, 2019
• Estimated Primary Completion Date: March 24, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Does Elective Amniocentesis Change Vaginal Microbiome?
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Vaginal Microbiome

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

Study Arms

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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 20, 2019): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 24, 2021
• Estimated Primary Completion Date: March 24, 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes

Contacts

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: Israel

Administrative Information

• NCT Number: NCT03884361
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Hillel Yaffe Medical Center
• Study Sponsor: Hillel Yaffe Medical Center
• Collaborators: Not Provided

Investigators

• Principal Investigator: Gabbay Gabbay Ben-Ziv, MD; Hillel Yaffe medical center, Hadera, Israel

• PRS Account: Hillel Yaffe Medical Center
• Verification Date: November 2019