Clinical Trial: Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy

Brief 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.

Detailed Summary:
Sponsor: Federal University of São Paulo

Current Primary Outcome:

• success of treatment [ Time Frame: 6 months ]
  β-hCG negative (<5 mIU / mL)
• Time required for titers of β-hCG to become negative [ Time Frame: 6 weeks ]
  After medication, monitoring will be done by measurement of β-hCG in the 4th and 7th day. If there ia a decrease > 15% in this range (4th and 7th), patient will be followed with weekly dosing of β-hCG until negative titers

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Blood tests before treatment with Methotrexate and Placebo [ Time Frame: 6 months ]
  Average value for tests: complete blood count, liver and renal function in the groups Methotrexate and Placebo before and after treatment
• Blood tests after treatment with Methotrexate and Placebo [ Time Frame: 6 months ]
  Average value for tests: complete blood count, liver and renal function in the groups Methotrexate and Placebo before and after treatment

Original Secondary Outcome: Same as current

Information By: Federal University of São Paulo

Dates:
Date Received: June 6, 2013
Date Started: September 2011
Date Completion:
Last Updated: June 10, 2013
Last Verified: June 2013