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Use of Fetoscopy in Missed Abortion

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ClinicalTrials.gov Identifier: NCT03799081
Recruitment Status : Unknown
Verified January 2019 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 10, 2019
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Abortion, Missed Procedure: Fetoscopy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Women who have undergone a missed abortion in the first trimester who want a surgical treatment option
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Use of Fetoscopy in Missed Abortion
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021
Arms and Interventions
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Arm Intervention/treatment
Fetoscopy in missed abortion
Women who have decided to undergo fetoscopy in missed abortion
 Procedure: Fetoscopy
Fetoscopy is a procedure that enables viewing of the fetus through use of a hysteroscope


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Minimize intrauterine adhesions through observation [ Time Frame: Two years ]
    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.

  2. Prevention of retained conception products [ Time Frame: Two years ]
    Prevention of retained conception products by hysteroscopy after curettage and visualization and observation of the contents of the womb


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women diagnosed with missed abortion during the first trimester of pregnancy

Exclusion Criteria:

  • Women diagnosed with missed abortion after the first trimester of pregnancy
  • Any contraindication for hysteroscopy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03799081


Contacts
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Contact: Emiliya Ilizirov, MD 972-532323246 emiliyailizirova@gmal.com

Locations
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Israel
Hille Yaffe Medical Center
Hadera, Israel, 38100
Contact: Emiliya Ilizirov, MD       emiliyailizirova@gmail.com   
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
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Principal Investigator: Sergio Haimovich, MD, PhD Hillel Yaffe Medical Center
More Information
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Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT03799081    
Other Study ID Numbers: HYMC-00056-18
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Abortion, Missed
Abortion, Spontaneous
Pregnancy Complications