Adnexal Mass After Methotrexate Treatment for Ectopic Pregnancies

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.

Study Overview

• Status: Unknown
• Conditions: Ectopic Pregnancies
• Intervention / Treatment: Other: BHCG monitoring

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Methotrexate injection; Patients with Ectopic pregnancy treated with Methotrexate injection.	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
Self resolution; Patients with Ectopic pregnancy that had signs of self resolution with our "Watchful waiting" protocol.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ectopic mass size	measuring and comparing the size of the ectopic mass	up to 6 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BHCG values	BHCG levels test in blood	up to 6 weeks.

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: Ishai Levin, professor, Tel Aviv Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2017
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: May 1, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (Actual): May 3, 2017

Study Record Updates

• Last Update Posted (Actual): May 3, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pregnancy Complications; Pregnancy, Ectopic; Cardiac Complexes, Premature
• Other Study ID Numbers: 614-16-TLV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No