Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy

Conditions
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Ectopic Pregnancy

Intervention / Treatment
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* Drug: Methotrexate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methotrexate<br>Administered a single intramuscular dose of 50 mg/m2 of Methotrexate. | Drug: Methotrexate<br>* 50 mg/m2, IM (intramuscularly), single dose<br>|
| Placebo Comparator: Placebo<br>Prescribed Placebo intramuscularly. | Drug: Placebo<br>* Prescribed Placebo IM (intramuscularly), single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success of treatment | β-hCG negative (<5 mIU / mL) | 6 months | 
| Time required for titers of β-hCG to become negative | 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 | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood tests before treatment with Methotrexate and Placebo | Average value for tests: complete blood count, liver and renal function in the groups Methotrexate and Placebo before and after treatment | 6 months | 
| Blood tests after treatment with Methotrexate and Placebo | Average value for tests: complete blood count, liver and renal function in the groups Methotrexate and Placebo before and after treatment | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ectopic pregnancy, methotrexate, human chorionic gonadotropin beta subunit, expectant management