drugset / Trial / NCT01876004

Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy

NCT01876004

Phase 4 Completed 25 enrolled Federal University of São Paulo
RandomizedParallel-groupDouble-blindTreatment

Summary

Objectives: To evaluate if, when considering expectant management in tubal ectopic pregnancy if the complementary use of Methotrexate could provide better results. We evaluate the success of treatment and the time required for titers of β-hCG to become negative. Methods: A double-blind randomized study, held at the Department of Obstetrics UNIFESP. The patients will be divided into two groups: in one patients will be administered a single intramuscular dose of 50 mg/m2 of Methotrexate and in the other patients will be prescribed Placebo intramuscularly. The monitoring will be done by measurement of β-hCG in the 4th and 7th day. When the decline of beta-hCG titers was \> 15% in this interval, the patient was followed with weekly dosing of β-hCG until the titers become negative. The criterion of success is when the β-hCG was negative. The treatment failure occurs when surgery was necessary.

Timeline

Start
2011-09
Primary completion
2013-01
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Methotrexate Small molecule 50 mg/m2 Intramuscular

Indications