Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy

Phase 4

Completed

• Conditions: Ectopic Pregnancy
• Interventions: Drug: Placebo; Drug: Methotrexate

• Registration Number: NCT01876004
• Lead Sponsor: Federal University of São Paulo

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 Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2013-01
• Status Verified: 2013-06
• Study Completion: 2013-06
• Study First Submitted: 2013-06-06
• Study First Submitted QC: 2013-06-10
• Last Update Submitted: 2013-06-10
• Study First Posted: 2013-06-12
• Last Update Posted: 2013-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Prescribed Placebo intramuscularly.
Methotrexate	Methotrexate	Administered a single intramuscular dose of 50 mg/m2 of Methotrexate.

Primary Outcome Measures

Name	Time	Method
success of treatment	6 months	β-hCG negative (\<5 mIU / mL)
Time required for titers of β-hCG to become negative	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 Outcome Measures

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

Trial Locations

Locations (1)

Federal University of Sao Paulo; 🇧🇷 São Paulo, SP, Brazil