The Accuracy of Ultrasound in the Detection of Placenta S... | NCT04579796

Studies
The Accuracy of Ultrasound in the Detection of Placenta Site in the First Trimester.

NCT04579796

Sponsor

Assaf-Harofeh Medical Center

Status

Suspended

Last Update Posted

Oct 8, 2020Actual

Enrollment

25Estimated

Phase

Not Applicable

Conditions

Placenta; Implantation

Interventions

ultrasound exam
hysteroscopy diagnostic

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of funding

Expanded Access Info

Start Date

Feb 1, 2019Actual

Primary Completion Date

Oct 1, 2020Estimated

Completion Date

Dec 30, 2020Estimated

First Submitted Date

Aug 26, 2020

First Submission Date that Met QC Criteria

Oct 2, 2020

First Posted Date

Oct 8, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2020

Last Update Posted Date

Oct 8, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

All women with a first trimester missed abortion who will sign an informed consent form will undergo an ultrasound examination. During the examination, the operator will assess the location of the placenta/sac insertion. After the performance of the ultrasound, the women will undergo hysteroscopy with a different operator who will be blinded to the results of the previous exam result. During the hysteroscopy the second operator will assess again the location of the sac insertion .The investigatorswill then compare the results of the two tests using the histeroscopy as the gold standard and evaluate the performance of abdominal ultrasound exam in the evaluation of placenta/ sac inserion.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
women with first trimester missed abortion	Experimental		Other: ultrasound exam Procedure: hysteroscopy diagnostic

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ultrasound exam	Other	An abdominal ultrasound exam to assess the placenta implantation site.	women with first trimester missed abortion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy women .
Clinical diagnosis of first trimester spontaneous abortion.

Exclusion Criteria:

viable pregnancy
women below 18 years
women with chronic disease

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided