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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methotrexate | Experimental | Administered a single intramuscular dose of 50 mg/m2 of Methotrexate. |
|
| Placebo | Placebo Comparator | Prescribed Placebo intramuscularly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate | Drug | 50 mg/m2, IM (intramuscularly), single dose |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julio Elito Junior | Federal University of São Paulo | Study Director |
| Luiz Camano | Federal University of São Paulo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Sao Paulo | São Paulo | São Paulo | Brazil |
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| ID | Term |
|---|---|
| D011271 | Pregnancy, Ectopic |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Placebo |
| Drug |
Prescribed Placebo IM (intramuscularly), single dose |
|
Average value for tests: complete blood count, liver and renal function in the groups Methotrexate and Placebo before and after treatment |
| 6 months |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |