Clincosm LogoSign in Get a demo

Use of Fetoscopy in Missed Abortion

Sponsor
Hillel Yaffe Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT03799081
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
4.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Fetoscopy
 N/A

Study Design

Study Type:
Interventional
Anticipated 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 optionWomen 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
Anticipated Study Start Date :
Jan 1, 2019
Anticipated Primary Completion Date :
Jan 1, 2021
Anticipated Study Completion Date :
Jan 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Macroscopic anatomic malformations in missed abortions [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 [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 [Two years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Hille Yaffe Medical Center Hadera Israel 38100

Sponsors and Collaborators

  • Hillel Yaffe Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT03799081
Other Study ID Numbers:
  • HYMC-00056-18
First Posted:
Jan 10, 2019
Last Update Posted:
Jan 10, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Abortion, Missed

Study Results

No Results Posted as of Jan 10, 2019