NCT04579796

Brief Summary

The investigators speculate that ultrasound examination in the first trimester can accurately detect placental location. By performing both transabdominal ultrasound and later hysteroscopy on women with a first trimester missed abortions and comparing the ultrasound findings to those of the hysteroscopy the investigators will evaluate the performance of the ultrasound in detecting the placenta location.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

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

Study Start

First participant enrolled

February 1, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

1.7 years

First QC Date

August 26, 2020

Last Update Submit

October 2, 2020

Conditions

Placenta; Implantation

Outcome Measures

Primary Outcomes (1)

  • The accuracy of placental site/ gestational sac implantation with ultrasound in the first trimester

    Transabdominal ultrasonography detection of gestational sac insertion location will be compared with gestational sac location diagnosed with hysteroscopy.

    up to 12 weeks

Study Arms (1)

women with first trimester missed abortion

EXPERIMENTAL
Other: ultrasound examProcedure: hysteroscopy diagnostic

Interventions

ultrasound examOTHER

An abdominal ultrasound exam to assess the placenta implantation site.

women with first trimester missed abortion
hysteroscopy diagnosticPROCEDURE

Diagnostic hysteroscopy to asses the placenta implantation site.

women with first trimester missed abortion

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy women .
  • Clinical diagnosis of first trimester spontaneous abortion.

You may not qualify if:

  • viable pregnancy
  • women below 18 years
  • women with chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asaf ha Rofeh, MC

Zrifin, 70300, Israel

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The performer of the hysteroscopy will not be aware of the result of the ultrasound exam
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 26, 2020

First Posted

October 8, 2020

Study Start

February 1, 2019

Primary Completion

October 1, 2020

Study Completion

December 30, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Locations

IL(1)