Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy

Federal University of São Paulo

Status and phase: Completed; Phase 4

Conditions: Ectopic Pregnancy

Treatments: Drug: Placebo; Drug: Methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT01876004

CEP UNIFESP 0772/11

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups, including a placebo group

Methotrexate

Experimental group

Description:

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

Treatment:

Drug: Methotrexate

Placebo

Placebo Comparator group

Description:

Prescribed Placebo intramuscularly.

Treatment:

Drug: Placebo