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

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

Study Overview

• Status: Completed
• Conditions: Pregnancy, Ectopic
• Intervention / Treatment: Drug: Multipe; Drug: Single

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Phase 4

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Hormozgan
    • Bandar Abbas, Hormozgan, Iran, Islamic Republic of, 79761
      • Shariaty Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
hCG level decrease	4 days after administration

Collaborators and Investigators

• Sponsor: Hormozgan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: August 5, 2012
• First Submitted That Met QC Criteria: August 9, 2012
• First Posted (Estimate): August 10, 2012

Study Record Updates

• Last Update Posted (Estimate): August 10, 2012
• Last Update Submitted That Met QC Criteria: August 9, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pregnancy Complications; Pregnancy, Ectopic; Cardiac Complexes, Premature
• Other Study ID Numbers: U1111-1133-3069