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Completed

NCT Number: NCT01876004

Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Federal University of Sao Paulo

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Hemodynamic stability
  • Initial β-hCG <2000 mIU / mL
  • Titers of β-hCG in decline in 48 hours before treatment
  • Adnexal mass <5.0 cm
  • Desire for future pregnancy

Exclusion criteria

  • Alive embryo
  • Ectopic pregnancy other than in tubal location
  • Pregnancy of unknown location

Treatment and study plan

methotrexate

Drug

50 mg/m2, IM (intramuscularly), single dose

Placebo

Drug

Prescribed Placebo IM (intramuscularly), single dose

Primary outcomes

  1. success of treatment

    Time frame: 6 months

    β-hCG negative (<5 mIU / mL)

  2. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 12, 2013
Registry last updated
Jun 12, 2013

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.

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