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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01662167
First Posted: August 10, 2012
Last Update Posted: August 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mohammad E Shahrzad, MD, Hormozgan University of Medical Sciences
  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 (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:


Further study details as provided by Mohammad E Shahrzad, MD, Hormozgan University of Medical Sciences:

Primary Outcome Measures:
  • hCG level decrease [ Time Frame: 4 days after administration ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: August 5, 2012
First Posted: August 10, 2012
Last Update Posted: August 10, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Pregnancy, Ectopic
Pregnancy Complications
Cardiac Complexes, Premature
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
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