NCT03884361

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2021

Completed
Last Updated

November 6, 2019

Status Verified

November 1, 2019

Enrollment Period

12 months

First QC Date

March 20, 2019

Last Update Submit

November 4, 2019

Conditions

Vaginal Microbiome

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Vaginal Microbiome as result of aminocentesis

EXPERIMENTAL

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

Interventions

Vaginal Microbiome as result of aminocentesisDIAGNOSTIC_TEST

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

Vaginal Microbiome as result of aminocentesis

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • infection in the Uterus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe medical center

Hadera, 3810101, Israel

RECRUITING

Study Officials

  • Gabbay Gabbay Ben-Ziv, MD

    Hillel Yaffe medical center, Hadera, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Osnat Palgi, BS.c

CONTACT

+972-4-7744602osnatp@hymc.gov.il

Rinat Gabbay Ben-Ziv, MD

CONTACT

RinatG@hy.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2019

First Posted

March 21, 2019

Study Start

April 1, 2019

Primary Completion

March 24, 2020

Study Completion

March 24, 2021

Last Updated

November 6, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)