Adnexal Mass After Methotrexate Treatment for Ectopic Pregnancies

Ectopic Pregnancies Clinical Trial

Official title:

Adnexal Mass After Methotrexate Treatment for Ectopic Pregnancies

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03138694
• Other study ID #: 614-16-TLV
• Status: Not yet recruiting
• Phase: N/A
• First received: May 1, 2017
• Last updated: May 2, 2017
• Start date: May 2017
• Est. completion date: October 2019

Study information

• Verified date: May 2017
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Ishai Levin, professor
• Phone: 052-4266977
• Email: ishail[@]tlvmc.gov.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Ectopic Pregnancies
• Pregnancy, Ectopic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ectopic mass size	measuring and comparing the size of the ectopic mass	up to 6 weeks.
Secondary	BHCG values	BHCG levels test in blood	up to 6 weeks.