Trial record 15 of 1163 for:    Open Studies | "Pregnancy"

Methotrexate Treatment for Ectopic Pregnancy

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by CHA University
Sponsor:
Information provided by (Responsible Party):
Taejong Song, CHA University
ClinicalTrials.gov Identifier:
NCT01855568
First received: May 10, 2013
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

Ectopic pregnancy is an important cause of maternal morbidity and occasionally mortality. Deaths associated with ectopic pregnancy have declined, though approximately 75% of deaths in the first trimester and 9-13% of all pregnancy-related deaths are associated ectopic pregnancy. The main stays of management for ectopic pregnancy were surgery and medical treatment. Medical management with systemic methotrexate administration avoids the inherent morbidity of anesthesia and surgery is cost-effective, and also offers success rates comparable to surgical management, with no loss in future potential fertility.

However, although medical management using methotrexate is used commonly, there is no solid consensus regarding dose protocol. Currently, there are three methotrexate protocols for the treatment of an ectopic pregnancy, "multi-dose", "single-dose", or "two-dose". Among them, the multi-dose protocol includes the administration of 4 methotrexate doses alternating with leucovorin (rescue regimen). As a result of the multiple dosing of methotrexate, side effects are more common. In contrast, the advantages of the single-dose protocol include elimination of a rescue regimen, lower incidence of adverse effects, and better compliance. However, the single-dose protocol was found to be associated with a considerably lower success rate as compared with the multi-dose protocol (88% versus 93%) in a recent meta-analysis. The two-dose protocol, which it balances efficacy and safety/convenience, was described as a cross between the multi-dose and single-dose protocols.

However, there were a few studies comparing between single-dose and two-dose protocol. The purpose of this prospective randomized trial was to compared the success rates of single-dose and two-dose methotrexate protocol for the treatment of tubal ectopic pregnancy.


Condition Intervention Phase
Ectopic Pregnancy
Procedure: Single-dose Methotrexate
Procedure: Two-dose methotrexate protocol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Two-dose and Single-dose Methotrexate Protocol for Ectopic Pregnancy: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by CHA University:

Primary Outcome Measures:
  • treatment success [ Time Frame: Up to 8 weeks (normal recovery time after treatment) ] [ Designated as safety issue: No ]
    Participants in both groups were considered a treatment success if β-hCG levels resolved to <5 mIU/mL without surgical intervention. The cases of participants who underwent surgical intervention were considered to have had treatment failure.


Estimated Enrollment: 92
Study Start Date: February 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single-dose methotrexate protocol
Participants in the "single-dose protocol" group received intramuscular methotrexate at single dose of 50 mg/m2 on day 0 (the initial day of treatment). The β-hCG levels were then measured on day 4 and 7. If there was at least 15% β-hCG drop between day 4 and 7, the treatment was deemed successful and the participants were then followed with weekly β-hCG measurements until the results was negative. If a 15% drop on day 4 and 7 did not occur, a second dose was administrated on day 7 and β-hCG levels were then measured on day 11 and 14. Participants were referred for surgical treatment if β-hCG levels fell <15% between day 11 and 14.
Procedure: Single-dose Methotrexate
Participants in the "single-dose protocol" group received intramuscular methotrexate at single dose of 50 mg/m2 on day 0 (the initial day of treatment). The β-hCG levels were then measured on day 4 and 7. If there was at least 15% β-hCG drop between day 4 and 7, the treatment was deemed successful and the participants were then followed with weekly β-hCG measurements until the results was negative. If a 15% drop on day 4 and 7 did not occur, a second dose was administrated on day 7 and β-hCG levels were then measured on day 11 and 14. Participants were referred for surgical treatment if β-hCG levels fell <15% between day 11 and 14.
Experimental: Two-dose methotrexate protocol
Participants in the "two-dose protocol" group received intramuscular methotrexate twice at dose of 50 mg/m2 on day 0 and 4. A third dose of methotrexate was given on day 7 if β-hCG levels did not fall 15% between day 4 and 7 after two-dosing. A fourth dose was administered on day 11 if β-hCG levels fell <15% between day 7 and 11. Then, a final β-hCG level was checked on day 14. If a 15% drop was not seen, the medical treatment was deemed refractory and the patients were referred for surgical treatment.
Procedure: Two-dose methotrexate protocol
Participants in the "two-dose protocol" group received intramuscular methotrexate twice at dose of 50 mg/m2 on day 0 and 4. A third dose of methotrexate was given on day 7 if β-hCG levels did not fall 15% between day 4 and 7 after two-dosing. A fourth dose was administered on day 11 if β-hCG levels fell <15% between day 7 and 11. Then, a final β-hCG level was checked on day 14. If a 15% drop was not seen, the medical treatment was deemed refractory and the patients were referred for surgical treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • tubal pregnancy
  • a gestational tubal mass with a largest diameter of 4 cm of less
  • hemodynamically stability
  • agreement to methotrexate treatment and follow up

Exclusion Criteria:

  • non-tubal pregnancy
  • baseline β-hCG level exceeding 15000 mIU/mL
  • presence of embryonic cardiac activity
  • clinically or sonographically suspected tubal rupture
  • laboratory tests showing possible deleterious effects of methotrexate treatment on organ functions
  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: NCT01855568

Contacts
Contact: Taejong Song, M.D. +82-10-4035-8405 taejong.song@gmail.com

Locations
Korea, Republic of
CHA Gangnam Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Taejong Song, M.D.    82-10-4035-8405    taejong.song@gmail.com   
Principal Investigator: Taejong Song, M.D.         
Sponsors and Collaborators
CHA University
Investigators
Principal Investigator: Taejong Song, M.D. CHA Gangnam Medical Center, Seoul, Republic of Korea
  More Information

No publications provided

Responsible Party: Taejong Song, Professor, CHA University
ClinicalTrials.gov Identifier: NCT01855568     History of Changes
Other Study ID Numbers: KNC13-006
Study First Received: May 10, 2013
Last Updated: November 21, 2013
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Pregnancy, Ectopic
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