The purpose of this study is to compare the effects of methotrexate and the combination of methotrexate - mifepristone in the treatment of ectopic pregnancy. In this double-blind single center study, 66 patients admitted to Imam Reza Hospital with a diagnosis of ectopic pregnancy will be recruited. The patients with stable hemodynamic status and adnex mass smaller than 4 cm BHCG level less than 1500mIU/ml, and no history of any specific disease, are randomized into two different groups to receive single dose of methotrexate 50mg/m2 intramuscular plus 600mg mifepristone orally or only a single dose of methotrexate with oral placebo. Beta HCG level, renal and liver function tests are examined in the fourth and seventh days after administration of these drugs. The most important outcome of this study is the success rate of treating ectopic pregnancy. This study will be conducting for 18 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010033461N3
Registration date:2010-10-31, 1389/08/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-10-31, 1389/08/09
Registrant information
Name
Firoozeh Veisi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1823 4276
Email address
f_veisi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2011-08-23, 1390/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparative study of the effects of methotrexate and combination of methotrexate-mifepristone in treatment of ectopic pregnancy
Public title
Effects of methotrexate and combination of methotrexate-mifepristone in treatment of ectopic pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: stable Hemodynamic state, Without Bleeding or hemo-peritoneum, un ruptured ectopic pregnancy, ectopic pregnancy mass without FHR, ectopic pregnancy mass smaller than 4cm, BHCG less than 1500 mlu/ml, no contradiction of use of methotrexate or mifepristone
Exclusion criteria: decrease in serum BHCG, BHCG less than1500 mlu/ml and depletion after 48 h, history of liver and renal diseases, hematologic or others disorders such as: glaucoma, porphyria, thalassemia, ulcerative colitis, heart diseases, psychological diseases, corticosteroid use more than 6 months, prior sensitivity to methotrexate or mifepristone
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Kermanshah University of Medical Sciences
Street address
Imam Reza hospital, Parastar Blvd., Kermanshah
City
Kermanshah
Postal code
6714415333
Approval date
2010-06-08, 1389/03/18
Ethics committee reference number
7/420/202 /پ
Health conditions studied
1
Description of health condition studied
Pregnancy with abortive outcome
ICD-10 code
O00
ICD-10 code description
Pregnancy with abortive outcome
Primary outcomes
1
Description
Ectopic Pregnancy treatment
Timepoint
Days 4, 7, 11, and 14
Method of measurement
Beta hCG level
Secondary outcomes
1
Description
need to second methotrexate injection
Timepoint
from 4th to 7th day
Method of measurement
BhcG level
2
Description
Rate of infection
Timepoint
4th, 7th and 11th day after intervention
Method of measurement
temperature more than 38 degree centigrade
3
Description
surgical intervention
Timepoint
4th day after intervention
Method of measurement
laparatomy
4
Description
Number of days required to reduce BhcG level
Timepoint
after 4th day
Method of measurement
Beta hcG level
5
Description
hospital stay
Timepoint
from admission to discharge
Method of measurement
Number of hospitalization dayshospitalization
Intervention groups
1
Description
50mg/m2 methotrexate IM, with single dose oral placebo (same as mifepristone)
Category
Placebo
2
Description
single dose of methorexate IM + 600mg mifepoistone oraly
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Kermanshah University of Medical Sciences
Full name of responsible person
Street address
Imam Reza Hospital, Parastar Blvd., Kermanshah University of Medical Sciences,
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Firoozeh Veisi
Street address
Imam Reza hospital, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Firoozeh Veisi
Position
Assistant professor of OB-GYN
Other areas of specialty/work
Street address
Imam Reza Hospital, Kermanshah University of Medical Science
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
Email
f_veisi@kums.ac.ir firoozehveisi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Firoozeh Veisi
Position
OB-GYN Assistant Professor
Other areas of specialty/work
Street address
Imam Reza Hospital, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
Email
f_veisi@kums.ac.ir firrozehveisi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Firoozeh Veisi
Position
OB-GYN Assistant professor
Other areas of specialty/work
Street address
Imam Reza Hospital, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
Email
f_veisi@kums.ac.ir firoozehveisi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)