BHCG Level in Day 4,7, in Comparison to Day 10 as an Indicator for Treatment Success

Ectopic Pregnancy Clinical Trial

— BHCG  

Official title:

BHCG Level in Day 4,7, in Comparison to Day 10 as an Indicator for Treatment Success

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01860690
• Other study ID #: BHCG1
• Status: Recruiting
• Phase: Phase 4
• First received: November 20, 2012
• Last updated: May 22, 2013
• Start date: November 2011
• Est. completion date: February 2014

Study information

• Verified date: December 2012
• Source: Meir Medical Center
• Contact: Zvi Klein, Dr.
• Phone: 972-9-7472544
• Email: kleinz[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Clalit Health Services
• Study type: Interventional

Clinical Trial Summary

The investigators want to compeer BHCG levels after Methotrexate ( MTX). treatment for Ectopic pregnancy in days 4 and 7 after MTX. to day 10 . The hypothesis is that "BHCG" level in day 10 is the best indicator for treatment success , superior to day 4 and 7 . According to the investigators impression BHCG level rises in days 4 and 7 due to destruction of the trophoblast tissue , and only day 10 is an indicator for treatment success

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• patients with ectopic pregnancy

• healthy

• hemodynamic stable

• first ectopic

Exclusion Criteria:

• hemodynamic non-stable

• abnormal liver or kidney function

• allergy reaction to MTX

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ectopic Pregnancy
• Pregnancy, Ectopic

Intervention

Drug:
• Methotrexate
50 mg / meter squer Intramuscular (IM) MTX.

Locations

Country	Name	City	State
Israel	Dr. Zvi Klein	Kefar-saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure the change of levels of "BHCG" in patients receiving Methotrexate for treatment of ectopic pregnancy in days 4, 7, and 10 post treatment	To compeer levels of BHCG in days 4 and 7 to day 10 after injection of MTX. for Ectopic pregnancy treatment	the change of levels in days 4, 7, and 10 post MTX injection	No