The aim of this study is to investigate and compare the effect of methotrexate and actinomycin D on patients with cesarean scar ectopic pregnancy, due to less side effects, more accessibility and less costs in the treatment by Actinomycin-D as a chemotherapy agent that has side effects similar to methotrexate without central nervous system’s side effects.
Design
Two arm parallel group, double-blind, randomized, phase 3 clinical trial on 32 patients. Lottery method used for randomization.
Settings and conduct
Eligible patients who referred to Hazrat Rasool Akram and Firozgar Hospital in Tehran were assigned to two groups, the first group received methotrexate and the second group Actinomycin D. Then, BHCG levels are recorded. If there is any complication, drop in hemoglobin or no reduction in BHCG, the intervention will be discontinued and resection of the mass will be performed by surgical intervention.
Participants/Inclusion and exclusion criteria
32 patients with C-section ectopic pregnancy will enrolled. Patients with vaginal bleeding and hemodynamic unstability will be excluded.
Intervention groups
First group will receive actinomycin D and the second methotrexate.
Main outcome variables
level of the blood chorionic gonadotropin hormone (BHCG)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151020024625N16
Registration date:2023-04-04, 1402/01/15
Registration timing:prospective
Last update:2023-04-04, 1402/01/15
Update count:0
Registration date
2023-04-04, 1402/01/15
Registrant information
Name
Mehrdad Zahmatkesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3343 7844
Email address
mehrdadzahmatkesh@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-05, 1402/02/15
Expected recruitment end date
2024-03-05, 1402/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of methotrexate and actinomycin D in the treatment of patients with C-section ectopic pregnancy
Public title
Assessing the effectiveness of methotrexate and actinomycin D in the treatment of patients with C-section ectopic pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed diagnosis of -section ectopic pregnancy
Exclusion criteria:
Gestational age more than 13 weeks at the time of diagnosis
Heavy vaginal bleeding
Hemodynamic changes
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, at first stage, 32 spheres from one to 32 are considered and following that will randomly divided into two equal parts, including "1" (Intervention1) and group 2 (Intervention2), and then using a lottery container, the ball of each group taken out and the intended sequence will be recorded.
Blinding (investigator's opinion)
Double blinded
Blinding description
The blinding of the study is such that the care provider, outcome assessor and biostatistician do not know the content of the intervention. For administration, the drug is drawn by the researcher into the syringe and given to the clinical care provider for administration by mentioning the administration method. The outcome assessor records the outcome based on the patient's identity number according to the randomization table, and the data collected based on the number and mention of the first and second intervention is provided to the biostatistician for analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Iran University of Medical Sciences
Street address
Hemmat Expressway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2022-08-06, 1401/05/15
Ethics committee reference number
IR.IUMS.FMD.REC.1401.269
Health conditions studied
1
Description of health condition studied
C-Section Ectopic Pregnancy
ICD-10 code
O00.9
ICD-10 code description
Ectopic pregnancy, unspecified
Primary outcomes
1
Description
Level of the blood chorionic gonadotropin hormone (BHCG)
Timepoint
4, 7, 14 and 21 days after intervention
Method of measurement
Enzyme-Linked Immunesorbent Assay (ELIZA)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Methotrexate is given as a single dose of 50 mg by intramuscular injection. This dose is repeated after 14 days if there is no therapeutic result.
Category
Treatment - Drugs
2
Description
Intervention group: Actinomycin D is given as a single dose of 0.5 mg by intravenous infusion. This dose is repeated after 14 days if there is no therapeutic result.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasool Akram hospital
Full name of responsible person
Soodabeh Jamali
Street address
Niyayesh
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
soodabehjamali@gmail.com
2
Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Soodabeh Jamali
Street address
Beh-Afarin Ave.
City
Tehran
Province
Tehran
Postal code
۱۵۹۳۷۴۷۸۱۱
Phone
+98 21 8214 1201
Email
soodabehjamali@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Samideh Khoei
Street address
Hemmat Expressway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8860 2219
Email
Schoolofmedicine@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Setareh Nasiri Zeidi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Niyayesh Ave.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
setare_n99@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Setare Nasiri Zeidi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Niyayesh Ave.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
setare_n99@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mehrdad Zahmatkesh
Position
Research Expert
Latest degree
Bachelor
Other areas of specialty/work
Epidemiology
Street address
Amin Avenue, Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3343 7838
Fax
Email
mehrdadzahmatkesh@semums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data collection will be presented anonymously.
When the data will become available and for how long
After publishing of the results, the data will be delivered upon request and after verification.
To whom data/document is available
The data will be available only for academic researchers.
Under which criteria data/document could be used
In order to conduct similar studies.
From where data/document is obtainable
Direct request from the scientific responsible.
What processes are involved for a request to access data/document
After request and authentication, the data will be provided.