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

NCT01662167 | Completed Phase 4

• 1 other identifier: U1111-1133-3069
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pregnancy, Ectopic

Outcome Measures

Primary Outcomes (1)

• hCG level decrease

  4 days after administration

Study Arms (2)

Multiple dose mtx

EXPERIMENTAL

mtx

Drug: Multipe

Single Dose

EXPERIMENTAL

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

Interventions

Single DRUG

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 Dose

Multipe DRUG

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

Multiple dose mtx

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• unruptured tubal EP
• gestational mass of less than or equal to 3.5 cm in ultrasonography report

You may not qualify if:

• hemodynamic instability
• contraindications related to the use of MTX
• hepatic
• renal and active pulmonary diseases
• peptic ulcer
• immune deficiency status
• alcohol abuse
• blood dyscreasia

Sponsors & Collaborators

• Hormozgan University of Medical Sciences: lead

Study Sites (1)

Shariaty Hospital

Bandar Abbas, Hormozgan, 79761, Iran

Location

MeSH Terms

Conditions

Pregnancy, Ectopic

Interventions

Single Person

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 5, 2012
• First Posted: August 10, 2012
• Study Start: January 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 10, 2012

Record last verified: 2012-08

Locations

IR (1)