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Comparison of Single and Multiple-dose Methotrexate Therapy for Ectopic Pregnancy

Primary Purpose

Pregnancy, Ectopic

Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Single
Multipe
Sponsored by
Hormozgan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy, Ectopic

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • unruptured tubal EP
  • gestational mass of less than or equal to 3.5 cm in ultrasonography report

Exclusion Criteria:

  • hemodynamic instability
  • contraindications related to the use of MTX
  • hepatic
  • renal and active pulmonary diseases
  • peptic ulcer
  • immune deficiency status
  • alcohol abuse
  • blood dyscreasia

Sites / Locations

  • Shariaty Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Multiple dose mtx

Single Dose

Arm Description

mtx

In the single dose regimen, 50 mg/m2 intramuscular methotrexate was given on day one and hCG level was measured on days four and seven. If the hCG level did not decrease by 15% between day four and seven, a second dose of methotrexate was injected on day seven, hCG level was measured weekly until a level of 15 mlU/ml or less was achieved

Outcomes

Primary Outcome Measures

hCG level decrease

Secondary Outcome Measures

Full Information

First Posted
August 5, 2012
Last Updated
August 9, 2012
Sponsor
Hormozgan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01662167
Brief Title
Comparison of Single and Multiple-dose Methotrexate Therapy for Ectopic Pregnancy
Official Title
Comparison of Single and Multiple-dose Methotrexate Therapy for Ectopic Pregnancy: a Clinical Trail
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hormozgan University of Medical Sciences

4. Oversight

5. Study Description

Brief Summary
The aim of this study was to compare single dose Methotrexate (MTX) to multiple dose MTX.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Ectopic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multiple dose mtx
Arm Type
Experimental
Arm Description
mtx
Arm Title
Single Dose
Arm Type
Experimental
Arm Description
In the single dose regimen, 50 mg/m2 intramuscular methotrexate was given on day one and hCG level was measured on days four and seven. If the hCG level did not decrease by 15% between day four and seven, a second dose of methotrexate was injected on day seven, hCG level was measured weekly until a level of 15 mlU/ml or less was achieved
Intervention Type
Drug
Intervention Name(s)
Single
Intervention Description
In the single dose regimen, 50 mg/m2 intramuscular methotrexate was given on day one and hCG level was measured on days four and seven. If the hCG level did not decrease by 15% between day four and seven, a second dose of methotrexate was injected on day seven, hCG level was measured weekly until a level of 15 mlU/ml or less was achieved
Intervention Type
Drug
Intervention Name(s)
Multipe
Intervention Description
In the multiple dose regimen, 1 mg/kg/day intramuscular methotrexate was given on days one, three, five and seven and 0.1 mg/kg/day intramuscular Citrovoram factor was administered on days two, four, six and eight until serum hCG level decreased 15% in 48 hours or four doses of methotrexate was given weekly until serum hCG level of 15 mlU/ml or less was obtained
Primary Outcome Measure Information:
Title
hCG level decrease
Time Frame
4 days after administration

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: unruptured tubal EP gestational mass of less than or equal to 3.5 cm in ultrasonography report Exclusion Criteria: hemodynamic instability contraindications related to the use of MTX hepatic renal and active pulmonary diseases peptic ulcer immune deficiency status alcohol abuse blood dyscreasia
Facility Information:
Facility Name
Shariaty Hospital
City
Bandar Abbas
State/Province
Hormozgan
ZIP/Postal Code
79761
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Comparison of Single and Multiple-dose Methotrexate Therapy for Ectopic Pregnancy

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