NCT03138694

Adnexal Mass After Methotrexate Treatment for Ectopic Pregnancies

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ectopic Pregnancies

Interventions

Type	Name	Description
OTHER	BHCG monitoring	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

Timeline

• Start date: 2017-05-01
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2017-05-03
• Last updated: 2017-05-03