Trial record 7 of 49 for:    ectopic pregnancy

Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Priscila Matthiesen e Silva, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01876004
First received: June 6, 2013
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Ectopic Pregnancy
Drug: Methotrexate
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • success of treatment [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    β-hCG negative (<5 mIU / mL)

  • Time required for titers of β-hCG to become negative [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Average value for tests: complete blood count, liver and renal function in the groups Methotrexate and Placebo before and after treatment


Enrollment: 25
Study Start Date: September 2011
Study Completion Date: June 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01876004

Locations
Brazil
Federal University of Sao Paulo
São Paulo, SP, Brazil
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Study Director: Julio Elito Junior Federal University of Sao Paulo
Study Director: Luiz Camano Federal University of Sao Paulo
  More Information

No publications provided

Responsible Party: Priscila Matthiesen e Silva, Obstetrics and Gynecologist, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01876004     History of Changes
Other Study ID Numbers: CEP UNIFESP 0772/11
Study First Received: June 6, 2013
Last Updated: June 10, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
ectopic pregnancy
methotrexate
human chorionic gonadotropin beta subunit
expectant management

Additional relevant MeSH terms:
Pregnancy, Ectopic
Pregnancy, Tubal
Pregnancy Complications
Cardiac Complexes, Premature
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014