The aim of this double blind trial is to compare the response to treatment by single and double dose of Methotrexate in Ectopic Pregnancy. Inclusion criteria: 1- Adenexal mass with a size of 4 cm at maximum; 2- β-hCG titration level less than 15000 mIU/mL; 3- Stable hemodynamic status; 4- No fetal heart activity in gestational sac; 5- consent for Methotrexate therapy and follow -up; 6- Normal laboratory tests. The cases will be hospitalized patients who suffer from EP with inclusion criteria in Al-Zahra Hospital. The sample size will be 146 women recognized as tubal EP by clinical signs ,transvaginal sonography and β-hCG titration level . After determining basic β-hCG titration level, These patients will be divided in two groups (single and double dose of Methotrexate) randomly via a computer-generated random numbers table. The single dose group will receive 50 mg/m2 Methotrexate intramuscularly on day 0 and the double dose group will receive the same dose on days 0 and 4 .All cases will be hospitalized during the first week of treatment. Then, they will be followed by referring to the gynecologic clinic at Al-Zahra hospital and β–hCG titration level and side effects will be assessed weekly . two groups will be compared according to : 1-Success rate that will be determined as a decrease of 15% or more in serum β–hCG titration level from day 4 to day 7 and subsequent decrease to lesser than 10 mIU/mL in 6 weeks without surgical intervention or repeated dosage ; 2- duration of treatment ; 3-Side effects of Methotrexate.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013051110089N3
Registration date:2013-09-03, 1392/06/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-03, 1392/06/12
Registrant information
Name
Roya Faraji Darkhaneh
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
h_fertility@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research Guilan university of medical sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2014-04-21, 1393/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between single and double dose of Methotrexate in Ectopic Pregnancy
Public title
Comparison between single and double dose of Methotrexate in Ectopic Pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- Andexal mass with a size of 4 cm at maximum ; 2- β–hCG titration level less than15000 mIU/mL; 3- Stable hemodynamic status -Blood Pressure > 90/60 mmHg and nonexistence of tachycardia ( Pulse Rate less than 100/min); 4-No fetal heart activity in gestational sac; 5- Consent for Methotrexate therapy and follow-up; 6- Normal laboratory tests(Platelet count more than 120000/µL , Serum Creatinin less than 1.2mg/dL or Aspartate aminotransferase less than double of normal level). Exclusion criteria: This study has not exclusion criteria .
Age
From 15 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
146
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This is a Double blind trial. The patient & the person who registers the data are not aware of the dosage of medication. Medication is prescribed by someone else.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Guilan University of Medical Sciences
Street address
Ethics Committee of Guilan University of Medical Sciences, Gaz Square
City
Rasht
Postal code
Approval date
2013-04-20, 1392/01/31
Ethics committee reference number
9210029710
Health conditions studied
1
Description of health condition studied
Tubal pregnancy
ICD-10 code
O00.1
ICD-10 code description
Fallopian pregnancy
Primary outcomes
1
Description
Treatment response in terms of basic β-hCG titration level by ELIZA technique
Timepoint
After first week of treatment and 6 weeks follow-up period
Method of measurement
Determining β-hCG titration level before treatment by ELIZA technique
2
Description
Therapeutic response to methotrexate
Timepoint
Day 4 and day 7, and its repetition weekly until 6 weeks
Method of measurement
Visit the patient and determining serum β–hCG titration level by ELIZA technique
3
Description
Treatment response in terms of longest ectopic mass diameter on Transvaginal Sonography
Timepoint
After first week of treatment and 6 weeks follow-up period
Method of measurement
Determining the longest ectopic mass diameter in terms of Ultrasound report before treatment
Secondary outcomes
1
Description
Follow-up days
Timepoint
After treatment and since first week of follow-up
Method of measurement
Duration of Treatment and follow-up until β–hCG titration level declined to less than 10 mIU/mL in terms of day by ELIZA technique
2
Description
Methotrexate side effects(Abdominal pain,Gastrointestinal symptoms,Alopecia ,Mucositis,Leukocyte count<4000,Platelet count<120000, Aspartate aminotransferase more than double level of normal).
Timepoint
After treatment and on first week of follow up
Method of measurement
History, checking liver function tests and Complete Blood Count (CBC)
Intervention groups
1
Description
After diagnosis of tubal EP and determining basic β–hCG titration level and checking kidney, liver function tests and Complete Blood Count (CBC) Methotrexate with a brand name EBETREX manufactured by EBEWE company, Austria is given to group (I) 50 mg/m2 intramuscularly on day 0 and day 4.
Category
Treatment - Drugs
2
Description
After diagnosis of tubal EP and determining basic β–hCG titration level and checking kidney, liver function tests and Complete Blood Count (CBC) Methotrexate with a brand name EBETREX manufactured by EBEWE company, Austria is given to group (II) 50 mg/m2 intramuscularly on day 0.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital, Guilan University of Medical Sciences
Full name of responsible person
Roya Faraji Darkhane
Street address
Alzahra Hospital, Namjo Street
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Guilan University of Medical Sciences
Full name of responsible person
Abdolrasol Sobhani
Street address
Gaz Square, Vice Chancellor for Research
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Aidin Raoofinia
Position
Obstetrics & Gynecology Resident of Medical Sciences
Other areas of specialty/work
Street address
Reproduction Health Center, Alzahra Hospital, Namjo Street,
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
A.Raoofinia@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Roya Faraji Darkhaneh
Position
Associated Professor Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Reproductive Health Research Center, Alzahra Hospital, Namjo Street
City
Rasht
Postal code
Phone
+98 911 131 1710
Fax
Email
royafaraji1371@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Nazli Peiravian
Position
B.S of Nursing
Other areas of specialty/work
Street address
Reproduction Health Center, Alzahra Hospital, Namjo Street,
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)