Brief Title
Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy
Official Title
Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
success of treatment
Secondary Outcome
Blood tests before treatment with Methotrexate and Placebo
Condition
Ectopic Pregnancy
Intervention
Methotrexate
Study Arms / Comparison Groups
Methotrexate
Description: Administered a single intramuscular dose of 50 mg/m2 of Methotrexate.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
25
Start Date
September 2011
Completion Date
June 2013
Primary Completion Date
January 2013
Eligibility Criteria
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Julio Elito Junior, ,
Location Countries
Brazil
Location Countries
Brazil
Administrative Informations
NCT ID
NCT01876004
Organization ID
CEP UNIFESP 0772/11
Responsible Party
Principal Investigator
Study Sponsor
Federal University of São Paulo
Study Sponsor
Julio Elito Junior, Study Director, Federal University of Sao Paulo
Verification Date
June 2013