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Use of Fetoscopy in Missed Abortion

Primary Purpose

Abortion, Missed

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Fetoscopy
Sponsored by
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Abortion, Missed

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hille Yaffe Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Fetoscopy in missed abortion

Arm Description

Women who have decided to undergo fetoscopy in missed abortion

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Prevention of retained conception products
Prevention of retained conception products by hysteroscopy after curettage and visualization and observation of the contents of the womb

Full Information

First Posted
November 5, 2018
Last Updated
January 7, 2019
Sponsor
Hillel Yaffe Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03799081
Brief Title
Use of Fetoscopy in Missed Abortion
Official Title
Use of Fetoscopy in Missed Abortion
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2019 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abortion, Missed

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Women who have undergone a missed abortion in the first trimester who want a surgical treatment option
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fetoscopy in missed abortion
Arm Type
Other
Arm Description
Women who have decided to undergo fetoscopy in missed abortion
Intervention Type
Procedure
Intervention Name(s)
Fetoscopy
Intervention Description
Fetoscopy is a procedure that enables viewing of the fetus through use of a hysteroscope
Primary Outcome Measure Information:
Title
Macroscopic anatomic malformations in missed abortions
Description
The number and type of macroscopic anatomic malformations in missed abortions will be determined through visual observation using a fetoscope
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Minimize intrauterine adhesions through observation
Description
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.
Time Frame
Two years
Title
Prevention of retained conception products
Description
Prevention of retained conception products by hysteroscopy after curettage and visualization and observation of the contents of the womb
Time Frame
Two years

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emiliya Ilizirov, MD
Phone
972-532323246
Email
emiliyailizirova@gmal.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergio Haimovich, MD, PhD
Organizational Affiliation
Hillel Yaffe Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hille Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emiliya Ilizirov, MD
Email
emiliyailizirova@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Use of Fetoscopy in Missed Abortion

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