Comparison effect of single dose of Methotrexate and Actinomycin D in the prevention of gestational trophoblastic neoplasia in patients with high risk hydatidiform mole who refer to Shahid Beheshti and Azahra hospitals of Isfahan university of medical sciences in 2020
Effect of single dose of actiomycin di and methotrexate on prevention of pregnancy trophoblastic neoplasia in high risk molar pregnancies
Design
In this study, 90 patients with high-risk molar pregnancy were randomly divided into three groups of 30 each. The first group received a single dose of actinomycin intravenously, the second group received 50 mg / m 2 of methotrexate and the third group received a single intramuscular B-ampoule an hour before curettage suction, followed by curettage.
Settings and conduct
TThis study is carried out during 1399 in Alzahra and Shahid Beheshti hospitals in Isfahan. Patients are randomly assigned to one of the three groups receiving actinomycin, methotrexate and sham at the time of admission to the hospital and, after receiving the intervention, curettage and suctioning is performed on the pineapple. .
Participants/Inclusion and exclusion criteria
In this study, women with complete molar pregnancy who are ready for surgery and termination of pregnancy with suction to discharge molar pregnancy and have at least one risk factor for disease progression to trophoblastic neoplasia of pregnancy are included.
Patients who do not have the drugs under study due to problems or medical complications or who are not ready for surgery and termination of pregnancy with suction to discharge the molar pregnancy are not entered in to the study.
Intervention groups
Intervention group 1: Injection single dose of actiomycin D intravenous bolus and then vein wash with 100 ml distilled water one hour before curettage suction
Intervention group 2: Injection 50 mg / m 2 intramuscular methotrexate injection one hour before curettage suction
Control group: Injection of intramuscular vitamin B complex as placebo one hour before curettage suction
Main outcome variables
Incidence of gestational trophoblastic neoplasia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130311012782N40
Registration date:2020-02-25, 1398/12/06
Registration timing:prospective
Last update:2020-02-25, 1398/12/06
Update count:0
Registration date
2020-02-25, 1398/12/06
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-02, 1399/01/14
Expected recruitment end date
2021-03-18, 1399/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of single dose of Methotrexate and Actinomycin D in the prevention of gestational trophoblastic neoplasia in patients with high risk hydatidiform mole who refer to Shahid Beheshti and Azahra hospitals of Isfahan university of medical sciences in 2020
Public title
omparison effect of single dose of Methotrexate and Actinomycin D in the prevention of gestational trophoblastic neoplasia in patients with high risk hydatidiform mole
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Full molar pregnancy
mother age above 40 years old
Patient's consent to participate in the study
Patient Preparation for Surgery and Termination of Pregnancy with Suction for Molar Discharge
Having risk factors for pregnancy progression to trophoblastic neoplasia
Exclusion criteria:
serum level of B-hCG >=100000 iu/ml
theca lutein cyst size >=6 cm
Age
From 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were divided into 3 groups included intervention group1, intervention group 2 and control group by using Random Allocation Software. The total sample size is entered into the software and the number of groups is specified. The software specifies the patients in each group by random number. based on the time of referral, patients will be divided into two groups according to the schedule to reach the required sample size in each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study was a double-blind study and patients were unaware of the type of drug being administered. The drug is also prescribed by the researcher, but the data are collected by another specialist physician who is unaware of the type of intervention received.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Research faculty, Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8434193474
Approval date
2019-12-20, 1398/09/29
Ethics committee reference number
IR.MUI.MED.REC.1398.344
Health conditions studied
1
Description of health condition studied
gestational trophoblastic neoplasia
ICD-10 code
O01.9
ICD-10 code description
gestational trophoblastic neoplasm
Primary outcomes
1
Description
Incidence of gestational trophoblastic neoplasia in Molar pregnancy
Timepoint
Every week for three weeks and the 6 months later
Method of measurement
measurement of beta HCH
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intravenous injection of a single dose of actinomycin D and then washing the vein with 10 ml distilled water one hour before suction curettage
Category
Prevention
2
Description
Intervention group: Intramuscular injection of 50 mg methotrexate one hour before curettage suction
Category
Prevention
3
Description
Control group: Intramuscular injection of one ampule B complex one hour before suction curettage
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Samaneh Maghzi
Street address
Alzaha hospital, Soffeh street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3668 5555
Email
samaneh.maghzi@gmail.com
2
Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Samane Maghzi
Street address
Shahi Beheshti hospital, Motahari street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 21 3669 5555
Email
samaneh.maghzi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Research faculty, Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3792 3070
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Samaneh Maghzi
Position
Resident of gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of gynecology, Sofehh street, Alzahra hospital
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3669 5555
Email
samaneh.maghzi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fahimeh Sabet
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of gynecology, Alzahra hospital, Soffeh street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3669 5555
Email
f_sabet@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Mehrabi
Position
statistical consultant
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Research faculty, school of medicine, Isfahan University of Medical Sciences, Hezar Jerib streetb
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3792 8081
Email
al.mehrabi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The project is owned by the state agency and cannot be published