Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy

Ectopic Pregnancy Clinical Trial

Official title:

Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01876004
• Other study ID #: CEP UNIFESP 0772/11
• Status: Completed
• Phase: Phase 4
• First received: June 6, 2013
• Last updated: June 10, 2013
• Start date: September 2011
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hemodynamic stability

• Initial ß-hCG <2000 mIU / mL

• Titers of ß-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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ectopic Pregnancy
• Pregnancy, Ectopic

Intervention

Drug:
• Methotrexate
50 mg/m2, IM (intramuscularly), single dose
• Placebo
Prescribed Placebo IM (intramuscularly), single dose

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success of treatment	ß-hCG negative (<5 mIU / mL)	6 months	Yes
Primary	Time required for titers of ß-hCG to become negative	After medication, monitoring will be done by measurement of ß-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 ß-hCG until negative titers	6 weeks	Yes
Secondary	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	Yes
Secondary	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	Yes