Vaginal MicrobiomeNCT03884361
Does Elective Amniocentesis Change Vaginal Microbiome?
A study testing Vaginal Microbiome as result of aminocentesis in people with Vaginal Microbiome, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
the aim of this study is to check if elective amniocentesis change vaginal microbiome Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Microbiome
- What is being tested?
- Vaginal Microbiome as result of aminocentesis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Apr 2019to 24 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- pregnant women between 18-45 years old , pregnant week is 16-24 , and a signle pregnant.
Who cannot join
- infection in the Uterus
Trial locations and contacts
1 site in 1 country.
Rinat Gabbay Ben-Ziv, MD contact
Israel1 site, 1 recruiting
- Recruiting
Hillel Yaffe medical center
Hadera, 3810101
Osnat Palgi, Bsc, +972-4-7744602, osnatp@hymc.gov.il
About this study
the aim of this study is to check if elective amniocentesis change vaginal microbiome
- Conditions
- Vaginal Microbiome
- Being tested
- Vaginal Microbiome as result of aminocentesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Vaginal Microbiome as result of aminocentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 Apr 2019
- Primary completion24 Mar 2020 (estimated)
- Study completion24 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal MicrobiomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Gabbay Gabbay Ben-Ziv, MD, Principal investigator, Hillel Yaffe medical center, Hadera, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884361
- Sponsor's protocol ID
- 0126-18-HYMC
- Status last verified
- Nov 2019
- First submitted
- 20 Mar 2019
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Elective Amniocentesis Change Vaginal Microbiome?
- ClinicalTrials.gov ID
- NCT03884361
- Acronym / sponsor ID
- 0126-18-HYMC
- Conditions
- Vaginal Microbiome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 24 Mar 2020 (estimated)
- Study completion
- 24 Mar 2021 (estimated)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the aim of this study is to check if elective amniocentesis change vaginal microbiome
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaginal Microbiome as result of aminocentesis | Experimental | Diagnostic Test: Vaginal Microbiome as result of aminocentesisaginal Microbiome as result of aminocentesis by a blood and a vaginal samples that will taken before and after the aminocentesis |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- pregnant women between 18-45 years old , pregnant week is 16-24 , and a signle pregnant.
Key exclusion criteria (1 listed)
- infection in the Uterus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal Microbiome as result of aminocentesiswe 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 | Diagnostic test | Vaginal Microbiome as result of aminocentesis |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
- Individual participant dataSharing planned: No
Related trials for Vaginal Microbiome
Not yet recruiting
A Clinical Trial to Evaluate the Effects of the NeuEve Dryness Treatment Kit on Vaginal Health, Comfort, and Quality of Life in Postmenopausal Women
Relieves Vaginal Dryness / Improves Self-Lubrication, Improves Strength & Elasticity of Vagina (Aka Collagen and Elastin)
Active, not recruitingObservational study
Is the Vaginal Microbiome and Metabolome Associated With Spontaneous Preterm Birth (sPTB) in Multiple Pregnancies?
Preterm Birth, Preterm Labor
RecruitingObservational study
The Influence of the Vaginal Microbiome on Clinical Pregnancy in Patients Undergoing a Euploid Embryo Transfer
Vaginal Microbiome
Recruiting
Improving Menstrual and VAginal Health for All
Effects of Menstrual Products on the Vaginal Microbiome
Recruiting
Synbiotics in Patients at RIsk fOr Preterm Birth
Preterm Spontaneous Labor With Preterm Delivery, Preterm Birth
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rinat Gabbay Ben-Ziv, MD contact
Gabbay Gabbay Ben-Ziv, MD principal investigator
Hillel Yaffe medical center, Hadera, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal Microbiome as result of aminocentesis in people with Vaginal Microbiome, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Osnat Palgi, BS.c (+972-4-7744602, osnatp@hymc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal Microbiome (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2019; AzTrials last refreshed its copy on 27 Oct 2026.