Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-01-05 @ 10:49 PM
Study NCT ID:
NCT03138694
Status:
UNKNOWN
Last Update Posted:
2017-05-03
First Post:
2017-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adnexal Mass After Methotrexate Treatment for Ectopic Pregnancies
Sponsor:
Tel-Aviv Sourasky Medical Center
Organization:
Study Overview
Official Title:
Adnexal Mass After Methotrexate Treatment for Ectopic Pregnancies
Status:
UNKNOWN
Status Verified Date:
2017-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: