Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy

June 10, 2013 updated by: Priscila Matthiesen e Silva, Federal University of São Paulo
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil
        • Federal University of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Methotrexate
Administered a single intramuscular dose of 50 mg/m2 of Methotrexate.
Drug: Methotrexate
50 mg/m2, IM (intramuscularly), single dose
Placebo Comparator: Placebo
Prescribed Placebo intramuscularly.
Drug: Placebo
Prescribed Placebo IM (intramuscularly), single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
success of treatment
Time Frame: 6 months
β-hCG negative (<5 mIU / mL)
6 months
Time required for titers of β-hCG to become negative
Time Frame: 6 weeks
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
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood tests before treatment with Methotrexate and Placebo
Time Frame: 6 months
Average value for tests: complete blood count, liver and renal function in the groups Methotrexate and Placebo before and after treatment
6 months
Blood tests after treatment with Methotrexate and Placebo
Time Frame: 6 months
Average value for tests: complete blood count, liver and renal function in the groups Methotrexate and Placebo before and after treatment
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Study Director: Julio Elito Junior, Federal University of São Paulo
  • Study Director: Luiz Camano, Federal University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

June 6, 2013

First Submitted That Met QC Criteria

June 10, 2013

First Posted (Estimate)

June 12, 2013

Study Record Updates

Last Update Posted (Estimate)

June 12, 2013

Last Update Submitted That Met QC Criteria

June 10, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEP UNIFESP 0772/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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