Adnexal Mass After Methotrexate Treatment for Ectopic Pregnancies

NCT ID: NCT03138694

Last Updated: 2017-05-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-31
• Study Completion Date: 2019-10-31

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.

Conditions

Ectopic Pregnancies

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Methotrexate injection

Patients with Ectopic pregnancy treated with Methotrexate injection.

BHCG monitoring

Intervention Type: 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

Self resolution

Patients with Ectopic pregnancy that had signs of self resolution with our "Watchful waiting" protocol.

BHCG monitoring

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ishai Levin, professor

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv Medical Center

Central Contacts

Ishai Levin, professor

Role: CONTACT

ishail@tlvmc.gov.il

052-4266977

Other Identifiers

614-16-TLV

Identifier Type: -

Identifier Source: org_study_id