Adnexal Mass After Methotrexate Treatment for Ectopic Pre... | NCT03138694

Studies
Adnexal Mass After Methotrexate Treatment for Ectopic Pregnancies

NCT03138694

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

May 3, 2017Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Ectopic Pregnancies

Interventions

BHCG monitoring

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

May 2017

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

May 2017Estimated

Primary Completion Date

Oct 2019Estimated

Completion Date

Oct 2019Estimated

First Submitted Date

May 1, 2017

First Submission Date that Met QC Criteria

May 2, 2017

First Posted Date

May 3, 2017Actual

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

May 2, 2017

Last Update Posted Date

May 3, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Ectopic pregnancies are a common morbidity in the gynaecological field. Previous work done by our team has shown the benefits of conservative treatment with only BHCG (Beta-Human Chorionic Gonadotropin) monitoring, proving that a vast number of patients will have a self resolution without the need for any further medical intervention. In addition, our working hypothesis is that this process in contrast to Methotrexate is a more physiologic one with less inflammatory and necrosis reaction.

OBJECTIVE To measure and compare the size of the ectopic mass and monitor BHCG levels of women treated with Methotrexate and those that had a self resolution process of their ectopic pregnancy.

Investigators aim to prove that the mass will have an enlargement trend after Methotrexate in contrast to being stable or decrease in size with conservative treatment.

Detailed Description

OBJECTIVE To measure and compare the size of the ectopic mass and monitor BHCG levels of women treated with Methotrexate and those that had a self resolution process of their ectopic pregnancy.

Investigators aim to prove that the mass will have an enlargement trend after Methotrexate in contrast to being stable or decrease in size with conservative treatment.

PATIENTS & METHODS Patients that will be offered to join the study are those that will be with either treated by a Methotrexate injection or those that had signs of self resolution with our "Watchful waiting" protocol.

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

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Methotrexate injection		Patients with Ectopic pregnancy treated with Methotrexate injection.	Other: BHCG monitoring
Self resolution		Patients with Ectopic pregnancy that had signs of self resolution with our "Watchful waiting" protocol.	Other: BHCG monitoring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BHCG monitoring	Other	Participants in the study will be invited to our outpatient clinic for BHCG monitoring including blood count and BHCG levels test and serial Transvaginal Ultrasound examination

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ectopic mass size	measuring and comparing the size of the ectopic mass	up to 6 weeks.

Secondary Outcomes

Measure	Description	Time Frame
BHCG values	BHCG levels test in blood	up to 6 weeks.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients admitted and treated for a diagnosis of Ectopic pregnancy in The Department of Gynecology, Lis Maternity Hospital.

Exclusion Criteria:

none

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

All patients admitted and treated for a diagnosis of Ectopic pregnancy in The Department of Gynecology, Lis Maternity Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ishai Levin, professor	Contact	052-4266977		ishail@tlvmc.gov.il

Overall Officials

Name	Affiliation	Role
Ishai Levin, professor	Tel Aviv Medical Center	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

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

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