Does Elective Amniocentesis Change Vaginal Microbiome?

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

Study Overview

• Status: Unknown
• Conditions: Vaginal Microbiome
• Intervention / Treatment: Diagnostic test: Vaginal Microbiome as result of aminocentesis

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Osnat Palgi, BS.c; Phone Number: +972-4-7744602; Email: osnatp@hymc.gov.il
• Study Contact Backup: Name: Rinat Gabbay Ben-Ziv, MD; Email: RinatG@hy.health.gov.il

Study Locations

• Israel
  • Hadera, Israel, 3810101
    • Recruiting
    • Hillel Yaffe Medical Center
    • Contact: Osnat Palgi, Bsc; Phone Number: +972-4-7744602; Email: osnatp@hymc.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hillel Yaffe Medical Center
• Investigators: Principal Investigator: Gabbay Gabbay Ben-Ziv, MD, Hillel Yaffe medical center, Hadera, Israel

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Anticipated): March 24, 2020
• Study Completion (Anticipated): March 24, 2021

Study Registration Dates

• First Submitted: March 20, 2019
• First Submitted That Met QC Criteria: March 20, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): November 6, 2019
• Last Update Submitted That Met QC Criteria: November 4, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 0126-18-HYMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No