Does Elective Amniocentesis Change Vaginal Microbiome?
Sponsor
Hillel Yaffe Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT03884361
Collaborator
(none)
50
1
1
23.8
2.1
Study Details
Study Description
Brief Summary
the aim of this study is to check if elective amniocentesis change vaginal microbiome
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated 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
:
Apr 1, 2019
Anticipated Primary Completion Date
:
Mar 24, 2020
Anticipated Study Completion Date
:
Mar 24, 2021
Arms and Interventions
| 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
Primary Outcome Measures
- Vaginal Microbiome [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
Criteria
Ages Eligible for Study:
18 Years
to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hillel Yaffe medical center | Hadera | Israel | 3810101 |
Sponsors and Collaborators
- Hillel Yaffe Medical Center
Investigators
- Principal Investigator: Gabbay Gabbay Ben-Ziv, MD, Hillel Yaffe medical center, Hadera, Israel
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT03884361
Other Study ID Numbers:
- 0126-18-HYMC
First Posted:
Mar 21, 2019
Last Update Posted:
Nov 6, 2019
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No