Abortion, MissedNCT03799081
Use of Fetoscopy in Missed Abortion
A study testing Fetoscopy in people with Abortion, Missed, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to evaluate the use of hysteroscopic embryoscopy or fetoscopy as a powerful diagnostic tool to provide better counseling for couples having experienced pregnancy loss. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abortion, Missed
- What is being tested?
- Fetoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2019to Jan 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women diagnosed with missed abortion during the first trimester of pregnancy
Who cannot join
- Women diagnosed with missed abortion after the first trimester of pregnancy
- Any contraindication for hysteroscopy
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hille Yaffe Medical Center
Hadera, 38100
Emiliya Ilizirov, MD, emiliyailizirova@gmail.com
About this study
The purpose of this study is to evaluate the use of hysteroscopic embryoscopy or fetoscopy as a powerful diagnostic tool to provide better counseling for couples having experienced pregnancy loss.
- Conditions
- Abortion, Missed
- Being tested
- Fetoscopy
- Medical subject headings
- Abortion, Missed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FetoscopyProcedure or surgery
Fetoscopy is a procedure that enables viewing of the fetus through use of a hysteroscope
| Study group | Role | What they receive |
|---|---|---|
| Fetoscopy in missed abortion | Other | Women who have decided to undergo fetoscopy in missed abortion Receives: Procedure: Fetoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macroscopic anatomic malformations in missed abortions
The number and type of macroscopic anatomic malformations in missed abortions will be determined through visual observation using a fetoscope
Measured: Two years
Secondary outcomes (2)
Minimize intrauterine adhesions through observation
To minimize intrauterine adhesions that might occur after curettage through the ability to visualize the womb and pregnancy site through a hysteroscope before the surgical procedure so that inadvertent intrauterine adhesions are minimized. After one year, if pregnancy is not achieved (due to intrauterine adhesions that cause infertility), a follow-up hysteroscopy will be performed and intrauterine adhesions can be visualized if they have occurred.
Measured: Two years
Prevention of retained conception products
Prevention of retained conception products by hysteroscopy after curettage and visualization and observation of the contents of the womb
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study startJan 2019 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion, MissedStudies 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
- Model description
- Women who have undergone a missed abortion in the first trimester who want a surgical treatment option
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sergio Haimovich, MD, PhD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799081
- Sponsor's protocol ID
- HYMC-00056-18
- Status last verified
- Jan 2019
- First submitted
- 5 Nov 2018
- Last updated
- 10 Jan 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 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Fetoscopy in Missed Abortion
- ClinicalTrials.gov ID
- NCT03799081
- Acronym / sponsor ID
- HYMC-00056-18
- Conditions
- Abortion, Missed
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jan 2019 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 10 Jan 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 purpose of this study is to evaluate the use of hysteroscopic embryoscopy or fetoscopy as a powerful diagnostic tool to provide better counseling for couples having experienced pregnancy loss.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Women who have undergone a missed abortion in the first trimester who want a surgical treatment option
| Arm | Type | Receives |
|---|---|---|
| Fetoscopy in missed abortion | Other | Procedure: FetoscopyWomen who have decided to undergo fetoscopy in missed abortion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women diagnosed with missed abortion during the first trimester of pregnancy
Key exclusion criteria (2 listed)
- Women diagnosed with missed abortion after the first trimester of pregnancy
- Any contraindication for hysteroscopy
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 |
|---|---|---|
| FetoscopyFetoscopy is a procedure that enables viewing of the fetus through use of a hysteroscope | Procedure or surgery | Fetoscopy in missed abortion |
Primary outcome
Macroscopic anatomic malformations in missed abortions
Time frame: Two years
The number and type of macroscopic anatomic malformations in missed abortions will be determined through visual observation using a fetoscope
2 secondary outcomes
Minimize intrauterine adhesions through observation
Time frame: Two years
Prevention of retained conception products
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Sergio Haimovich, MD, PhD principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fetoscopy in people with Abortion, Missed, 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 2 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 10 Jan 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 Emiliya Ilizirov, MD (972-532323246, emiliyailizirova@gmal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macroscopic anatomic malformations in missed abortions (time frame: Two years). 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 10 Jan 2019.