Comparison of Single and Multiple-dose Methotrexate Therapy for Ectopic Pregnancy
NCT ID: NCT01662167
Last Updated: 2012-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
87 participants
INTERVENTIONAL
2008-01-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Multiple dose mtx
mtx
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
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
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* gestational mass of less than or equal to 3.5 cm in ultrasonography report
Exclusion Criteria
* contraindications related to the use of MTX
* hepatic
* renal and active pulmonary diseases
* peptic ulcer
* immune deficiency status
* alcohol abuse
* blood dyscreasia
FEMALE
No
Sponsors
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Hormozgan University of Medical Sciences
OTHER
Responsible Party
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Mohammad E Shahrzad, MD
Dr
Locations
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Shariaty Hospital
Bandar Abbas, Hormozgan, Iran
Countries
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Other Identifiers
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U1111-1133-3069
Identifier Type: -
Identifier Source: org_study_id