comparing the efficacy of methotrexate and laparoscopic salpingostomy in treating patients with ectopic pregnancy and their role in fallopian tubes patency
The aim of this study is to compare the efficacy of methotrexate (MTX) as a medical treatment with laparoscopic salpingostomy as a surgical approach in patients with ectopic pregnancy. Furthermore, the effects of these treatments on fallopian tubes patency will be studied. Diagnosis of ectopic pregnancy will be made based on an adnexal mass without cardiac function in transvaginal ultrasound and a B-hCG level below 5000 IU/L. This study is a randomized clinical trial. Fourty patients with ectopic pregnancy and hemodynamic stability will be randomly assigned into two groups. The patients in the first group will receive two doses of MTX (50 mg/m2) and the other group will undergo a laparoscopic salpingostomy. Complete treatment is defined as a decrease in B-hCG level up to non-pregnancy levels. Additionally, eight weeks after the time that B-hCG test became negative, fallopian tubes patency will be assessed by hystrosalpingography
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212121556N49
Registration date:2012-12-23, 1391/10/03
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-12-23, 1391/10/03
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2012-12-30, 1391/10/10
Expected recruitment end date
2013-04-21, 1392/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparing the efficacy of methotrexate and laparoscopic salpingostomy in treating patients with ectopic pregnancy and their role in fallopian tubes patency
Public title
comparing the efficacy of methotrexate and laparoscopic salpingostomy in treating patients with ectopic pregnancy and their role in fallopian tubes patency
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:
1- hemodynamic stability
2- ectopic mass size below 4 cm
3- patients' commitment for complete treatment and follow up
4- absence of MTX treatment contraindication
Exclusion criteria:
1- breast feeding
2- immune deficiency
3- abnormalities in hematologic system including anemia, locopenia, thrombocytopenia
4- known hypersensivity reaction to MTX
5- acute respiratory disease
6- acute peptic ulcer
7- alcoholism
8- clinical malfunction of liver and kidney
9- evidence of acute intraabdominal bleeding
10- evidence of cardiac function in the embryo
11- clinical sign and symptom of ectopic pregnancy, or B-hCG level below 5000 IU/L (with mild sign and symptoms)
Age
From 20 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Ethic Committee of Tehran University of Medical Sciences
Street address
Ethic Committee of Tehran University of Medical Sciences, 16 azar avenue, Keshavarz bolvar
City
tehran
Postal code
Approval date
2012-10-22, 1391/08/01
Ethics committee reference number
17892
Health conditions studied
1
Description of health condition studied
ectopic pregnancy
ICD-10 code
000
ICD-10 code description
Ectopic pregnancy
Primary outcomes
1
Description
B-hCG level
Timepoint
at the end of study
Method of measurement
blood sampling
Secondary outcomes
1
Description
fallopian tubes patency
Timepoint
eight weeks after the time that B-hCG test became negative
Method of measurement
histerosalpingography
Intervention groups
1
Description
MTX (two doses)
Category
Treatment - Drugs
2
Description
laparoscopic salpingostomy
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Hospital
Full name of responsible person
Dr. Ladan Kashani
Street address
Tehran Pars, Rashid Street, Arash Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Foutohi
Street address
Tehran University of Medical Sciences, Keshavarz Blvd
City
Tehran
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, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ladan Kashani
Position
Assistant Prof.
Other areas of specialty/work
Street address
Arash Hospital, Rashid Street, Tehran Pars
City
Tehran
Postal code
Phone
+98 21 7788 3195
Fax
Email
Kashani_ladan@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ladan Kashani
Position
Assistant Prof.
Other areas of specialty/work
Street address
Arash Hospital, Rashid Street, Tehran Pars
City
Tehran
Postal code
Phone
+98 21 7788 3195
Fax
Email
kashani_ladan@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ladan Kashani
Position
Assistant Prof.
Other areas of specialty/work
Street address
Arash Hospital, Rashid Street, Tehran Pars
City
Tehran
Postal code
Phone
+98 21 7788 3195
Fax
Email
kashani_ladan@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)