Use of Fetoscopy in Missed Abortion

January 7, 2019 updated by: Hillel Yaffe Medical Center
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two years
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
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Investigators

  • Principal Investigator: Sergio Haimovich, MD, PhD, Hillel Yaffe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2019

Primary Completion (ANTICIPATED)

January 1, 2021

Study Completion (ANTICIPATED)

January 1, 2021

Study Registration Dates

First Submitted

November 5, 2018

First Submitted That Met QC Criteria

January 7, 2019

First Posted (ACTUAL)

January 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 10, 2019

Last Update Submitted That Met QC Criteria

January 7, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYMC-00056-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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