Ectopic Pregnancy
Conditions
Keywords
ectopic pregnancy, methotrexate, human chorionic gonadotropin beta subunit, expectant management
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.
Interventions
DRUGMethotrexate
50 mg/m2, IM (intramuscularly), single dose
DRUGPlacebo
Prescribed Placebo IM (intramuscularly), single dose
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Brazil
Outcome results
None listed