The Correlation Between Uterine Endometrial Pattern and E... | NCT02963012

Studies
The Correlation Between Uterine Endometrial Pattern and Ectopic Pregnancy

NCT02963012

Sponsor

HaEmek Medical Center, Israel

Status

Unknown status

Last Update Posted

Nov 15, 2016Estimated

Enrollment

242Estimated

Phase

Not provided

Conditions

Ectopic Pregnancy

Interventions

ultrasound examination

Countries

Not provided

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

Nov 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016

Primary Completion Date

Dec 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Sep 12, 2016

First Submission Date that Met QC Criteria

Nov 14, 2016

First Posted Date

Nov 15, 2016Estimated

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

Nov 14, 2016

Last Update Posted Date

Nov 15, 2016Estimated

Name	Class
Ziv Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

A prospective trail. Pregnant women in the first trimester with positive BHCG and no visualization of gestational sac will be recruited.

The correlation between endometrial pattern and ectopic pregnancy will be assessed.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

242Estimated

Name	Type	Description	Arm Group Labels	Other Names
ultrasound examination	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the corellation between presence and width of trilaminar endometrium as evaluated by transvaginal ultrasound and the diagnosis of ectopic pregnancy		first trimester of pregnancy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

First trimester of pregnancy
No visualization of gestational sac

Exclusion Criteria:

Hemodynamic instability

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Women with ectopic pregnancy, in the first trimester.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011271	Pregnancy, Ectopic

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided