search
Back to results

Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy

Primary Purpose

Ectopic Pregnancy

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Methotrexate
Placebo
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ectopic Pregnancy focused on measuring ectopic pregnancy, methotrexate, human chorionic gonadotropin beta subunit, expectant management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Federal University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Methotrexate

Placebo

Arm Description

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

Prescribed Placebo intramuscularly.

Outcomes

Primary Outcome Measures

success of treatment
β-hCG negative (<5 mIU / mL)
Time required for titers of β-hCG to become negative
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 Outcome Measures

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
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

Full Information

First Posted
June 6, 2013
Last Updated
June 10, 2013
Sponsor
Federal University of São Paulo
search

1. Study Identification

Unique Protocol Identification Number
NCT01876004
Brief Title
Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy
Official Title
Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ectopic Pregnancy
Keywords
ectopic pregnancy, methotrexate, human chorionic gonadotropin beta subunit, expectant management

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methotrexate
Arm Type
Experimental
Arm Description
Administered a single intramuscular dose of 50 mg/m2 of Methotrexate.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Prescribed Placebo intramuscularly.
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
50 mg/m2, IM (intramuscularly), single dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Prescribed Placebo IM (intramuscularly), single dose
Primary Outcome Measure Information:
Title
success of treatment
Description
β-hCG negative (<5 mIU / mL)
Time Frame
6 months
Title
Time required for titers of β-hCG to become negative
Description
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
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Blood tests before treatment with Methotrexate and Placebo
Description
Average value for tests: complete blood count, liver and renal function in the groups Methotrexate and Placebo before and after treatment
Time Frame
6 months
Title
Blood tests after treatment with Methotrexate and Placebo
Description
Average value for tests: complete blood count, liver and renal function in the groups Methotrexate and Placebo before and after treatment
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julio Elito Junior
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Luiz Camano
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Federal University of Sao Paulo
City
São Paulo
State/Province
SP
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy

We'll reach out to this number within 24 hrs