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

Pregnancy, Ectopic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01662167
• Other study ID #: U1111-1133-3069
• Status: Completed
• Phase: Phase 4
• First received: August 5, 2012
• Last updated: August 9, 2012
• Start date: January 2008
• Est. completion date: December 2011

Study information

• Verified date: August 2012
• Source: Hormozgan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Hormozgan University of Medical Sciences
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy, Ectopic

Intervention

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
• 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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shariaty Hospital	Bandar Abbas	Hormozgan

Sponsors (1)

Lead Sponsor	Collaborator
Hormozgan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hCG level decrease		4 days after administration	No