NCT01860690

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2012

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 23, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

May 23, 2013

Status Verified

December 1, 2012

Enrollment Period

2 years

First QC Date

November 20, 2012

Last Update Submit

May 22, 2013

Conditions

Keywords

MTXEctopic pregnancymedical treatment

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

MTX , treatment outcome

EXPERIMENTAL

patient receiving MTX. in a dosage of 50 mg/m\^2 , IM , in single dose

Drug: Methotrexate

Interventions

50 mg / meter squer Intramuscular (IM) MTX.

MTX , treatment outcome

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients with ectopic pregnancy
  • healthy
  • hemodynamic stable
  • first ectopic

You may not qualify if:

  • hemodynamic non-stable
  • abnormal liver or kidney function
  • allergy reaction to MTX

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Zvi Klein

Kfar Saba, Israel

RECRUITING

MeSH Terms

Conditions

Pregnancy, Ectopic

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2012

First Posted

May 23, 2013

Study Start

November 1, 2011

Primary Completion

November 1, 2013

Study Completion

February 1, 2014

Last Updated

May 23, 2013

Record last verified: 2012-12

Locations