Comparison of efficacy and side effects of both single-dose and two-dose methotrexate therapy in ectopic pregnancy in patients referred to Imam Khomeini Hospital in Ahvaz
In this study we compared single dose with double dose of methotoxate (MTX) therapy for treatment of 76 patients with ectopic pregnancy referring to Imam Khomeini hospital of Ahvaz.
Inclusion criteria were, healthy women with stable hemodynamic condition and BHCG less than 15000 mU/mL .Women who had a history of liver and kidney disease or blood dyscrasia, breastfed were excluded from the study. the sample size was calculated 76 patients (38 in each single or double dose group). In single dose group, 50mg/m2 methotrexate was administered in day 0, while in the double dose group; patients received two doses in day 0 and 4. BHCG of both groups were measured in 4th and 7th day of hospitalization. A 15% decrease in BHCG level considered as a successful treatment. . If the rupture of fallopian tube has happened, patient underwent the immediate surgery. The necessity of surgery was determined in both groups.
Every woman remained hospitalized until their BHCG reached 200 mU/mL . Beside of BHCG level the duration of hospitalization also determined for single dose and double dose groups.
The side effects of methotrexate, function of liver and kidney were checked in each participant one week after completion of treatment , If liver trans aminase increased 1.5 times more than normal, or creatinine increased to 1.5mg/dL, WBCs decreased to 2000 or platelets declined fewer than 100000, these were assumed as drug complications and compared between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015080523519N1
Registration date:2015-08-18, 1394/05/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-18, 1394/05/27
Registrant information
Name
Sara Safyari
Name of organization / entity
Ahwaz Jondishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4421 4270
Email address
safyari.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz Jondishapur University of Medical Sciences
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2014-04-20, 1393/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and side effects of both single-dose and two-dose methotrexate therapy in ectopic pregnancy in patients referred to Imam Khomeini Hospital in Ahvaz
Public title
Efficacy of two-dose methotrexate therapy in ectopic pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: stable hemodynamic condition;
low free fluid intrapritoneal on ultrasound; BHCG less than 15000 mU/mL; no history of liver or renal disease or blood dyscrasia; no breastfeeding and patient satisfaction.
Exclusion criteria: unwillingness to continue participation in the study; unstable hemodinamic condition.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahwaz Jundishapur University of Medical Sciences
Street address
Ahwaz Jundishapur University of Medical Sciences, Daneshgah Sq.
City
Ahwaz
Postal code
6135-15794
Approval date
2013-05-04, 1392/02/14
Ethics committee reference number
AJUMS.REC.1392.19
Health conditions studied
1
Description of health condition studied
Ectopic pregnancy
ICD-10 code
O00.9
ICD-10 code description
Ectopic pregnancy, unspecified
Primary outcomes
1
Description
The overall success(15% reduction in β-HCG level )
Timepoint
At days: 4 and 7
Method of measurement
Lab test
Secondary outcomes
1
Description
The time BHCG reached 200 mU/mL
Timepoint
daily
Method of measurement
Lab test
2
Description
Side effects
Timepoint
7 days after treetment
Method of measurement
If liver trans aminase increased 1.5 times more than normal, or creatinine increased to 1.5mg/dL, WBCs decreased to 2000 or platelets declined fewer than 100000, these were assumed as drug complications
3
Description
The rate of surgery
Timepoint
During the follow-up period
Method of measurement
If the rupture of fallopian tube has happened, patient underwent the immediate surgery
Intervention groups
1
Description
In single dose group
50mg/m2 methotrexate was administered in day 0
Category
Treatment - Drugs
2
Description
In the double dose group; patients received two doses (50mg/m2 methotrexate) in day 0 and 4
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Ahwaz
Full name of responsible person
Sara Safyari
Street address
Imam Khomeini Hospital, Azadeghan street
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Nader Saki
Street address
Ahwaz Jundishapur University of Medical Sciences, Daneshghah square
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahwaz Jundishapur 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
Ahwaz Jondishapur University of Medical Sciences
Full name of responsible person
Sara Safyari
Position
Speciality doctorate degree in Obstetrics and Gynecology
Other areas of specialty/work
Street address
Emam Khomeini hospital of Ahwaz, Azadegan St.
City
Ahwaz
Postal code
Phone
+98 612227317
Fax
Email
dr_safyari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz Jondishapur University of Medical Sciences
Full name of responsible person
Najmie Saadati
Position
Speciality doctorate degree in Obstetrics and Gynecology/Associate Professor
Other areas of specialty/work
Street address
Emam Khomeini hospital of Ahwaz, Azadegan St.
City
Ahwaz
Postal code
Phone
+98 612227317
Fax
Email
NIL2F@Yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahwaz Jondishapur University of Medical Sciences
Full name of responsible person
Najmie Saadati
Position
Speciality doctorate degree in Obstetrics and Gynecology/Associate Professor
Other areas of specialty/work
Street address
Emam Khomeini hospital of Ahwaz, Azadegan St.
City
Ahwaz
Postal code
Phone
+98 612227317
Fax
Email
NIL2F@Yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)