Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-06-30

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.

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Detailed Description

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Conditions

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Ectopic Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Methotrexate

Administered a single intramuscular dose of 50 mg/m2 of Methotrexate.

Group Type EXPERIMENTAL

Methotrexate

Intervention Type DRUG

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

Placebo

Prescribed Placebo intramuscularly.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Prescribed Placebo IM (intramuscularly), single dose

Interventions

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Methotrexate

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

Intervention Type DRUG

Placebo

Prescribed Placebo IM (intramuscularly), single dose

Intervention Type DRUG

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