Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy

NCT01876004 | Completed Phase 4

• 1 other identifier: CEP UNIFESP 0772/11
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Ectopic Pregnancy

Keywords

ectopic pregnancy; methotrexate; human chorionic gonadotropin beta subunit; expectant management

Outcome Measures

Primary Outcomes (2)

• success of treatment

  β-hCG negative (\<5 mIU / mL)

  6 months

• 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

  6 weeks

Secondary Outcomes (2)

• Blood tests before treatment with Methotrexate and Placebo

  6 months

• Blood tests after treatment with Methotrexate and Placebo

  6 months

Study Arms (2)

Methotrexate

EXPERIMENTAL

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

Drug: Methotrexate

Placebo

PLACEBO COMPARATOR

Prescribed Placebo intramuscularly.

Drug: Placebo

Interventions

Methotrexate DRUG

50 mg/m2, IM (intramuscularly), single dose

Methotrexate

Placebo DRUG

Prescribed Placebo IM (intramuscularly), single dose

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Alive embryo
• Ectopic pregnancy other than in tubal location
• Pregnancy of unknown location

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Pregnancy, Ectopic

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Julio Elito Junior

  Federal University of São Paulo

  STUDY DIRECTOR

• Luiz Camano

  Federal University of São Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Obstetrics and Gynecologist

Study Record Dates

• First Submitted: June 6, 2013
• First Posted: June 12, 2013
• Study Start: September 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 12, 2013

Record last verified: 2013-06

Locations

BR (1)