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

Comparison of Single and Multiple-dose Methotrexate Therapy for Ectopic Pregnancy: a Clinical Trail

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01662167
Enrollment
87
Registered
2012-08-10
Start date
2008-01-31
Completion date
2011-12-31
Last updated
2012-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy, Ectopic

Brief summary

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

Interventions

DRUGSingle

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

DRUGMultipe

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

Sponsors

Hormozgan University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
hCG level decrease4 days after administration

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026