NCT03799081

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 10, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

January 10, 2019

Status Verified

January 1, 2019

Enrollment Period

2 years

First QC Date

November 5, 2018

Last Update Submit

January 7, 2019

Conditions

Abortion, Missed

Outcome Measures

Primary Outcomes (1)

  • 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

    Two years

Secondary Outcomes (2)

  • Minimize intrauterine adhesions through observation

    Two years

  • Prevention of retained conception products

    Two years

Study Arms (1)

Fetoscopy in missed abortion

OTHER

Women who have decided to undergo fetoscopy in missed abortion

Procedure: Fetoscopy

Interventions

FetoscopyPROCEDURE

Fetoscopy is a procedure that enables viewing of the fetus through use of a hysteroscope

Fetoscopy in missed abortion

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Women diagnosed with missed abortion after the first trimester of pregnancy
  • Any contraindication for hysteroscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hille Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Abortion, Missed

Interventions

Fetoscopy

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Prenatal DiagnosisDiagnostic Techniques, Obstetrical and GynecologicalDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalFetal TherapiesTherapeuticsMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeObstetric Surgical Procedures

Study Officials

  • Sergio Haimovich, MD, PhD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emiliya Ilizirov, MD

CONTACT

972-532323246emiliyailizirova@gmal.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Women who have undergone a missed abortion in the first trimester who want a surgical treatment option
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2018

First Posted

January 10, 2019

Study Start

January 1, 2019

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

January 10, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)