Adnexal Mass After Methotrexate Treatment for Ectopic Pregnancies

• Conditions: Ectopic Pregnancies
• Interventions: Other: BHCG monitoring

• Registration Number: NCT03138694
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

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

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.

Study Timeline

• Status Verified: 2017-05
• Study Start: 2017-05
• Study First Submitted: 2017-05-01
• Study First Submitted QC: 2017-05-02
• Last Update Submitted: 2017-05-02
• Study First Posted: 2017-05-03
• Last Update Posted: 2017-05-03
• Primary Completion: 2019-10
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

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

Exclusion Criteria

none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
ectopic mass size	up to 6 weeks.	measuring and comparing the size of the ectopic mass

Secondary Outcome Measures

Name	Time	Method
BHCG values	up to 6 weeks.	BHCG levels test in blood