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

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

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Key information

Conditions

Pregnancy, Ectopic Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Shariaty Hospital

Bandar Abbas, Hormozgan, 79761, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

hCG level decrease

Time frame: 4 days after administration

Sponsors and collaborators

Lead sponsor

Hormozgan University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Aug 10, 2012
Registry last updated: Aug 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed