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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mohammad E Shahrzad, MD, Hormozgan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01662167
First received: August 5, 2012
Last updated: August 9, 2012
Last verified: August 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Pregnancy, Ectopic
 Drug: Single
Drug: Multipe
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Single and Multiple-dose Methotrexate Therapy for Ectopic Pregnancy: a Clinical Trail

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hormozgan University of Medical Sciences:

Primary Outcome Measures:
  • hCG level decrease [ Time Frame: 4 days after administration ] [ Designated as safety issue: No ]

Enrollment: 87
Study Start Date: January 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multiple dose mtx
mtx
 Drug: Multipe
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
Experimental: Single Dose
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
 Drug: Single
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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01662167

Locations
Iran, Islamic Republic of
Shariaty Hospital
Bandar Abbas, Hormozgan, Iran, Islamic Republic of, 79761
Sponsors and Collaborators
Hormozgan University of Medical Sciences
  More Information

No publications provided

Responsible Party: Mohammad E Shahrzad, MD, Dr, Hormozgan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01662167     History of Changes
Other Study ID Numbers: U1111-1133-3069
Study First Received: August 5, 2012
Last Updated: August 9, 2012
Health Authority: Iran: Hormozgan University of Medical Sciences

Additional relevant MeSH terms:
Pregnancy, Ectopic
Cardiac Complexes, Premature
Pregnancy Complications
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013