Determination and comparison of misoprostol and trinitrate glycerin (TNG) effects for cervix preparation for diagnostic curettage at Shahid Sayyad Shirazi Medical Center
Design
. After obtaining a detailed history, a complete physical examination, and checking CBC, BG and RH, as well as the cervical dilatation level from patients, will be determined before the drug administration.
Subjects will then be randomly assigned to either group A (TNG recipients) and group B (misoprostol recipients). Group A will receive three doses of vaginal TNG (manufactured by Zahravi Pharmaceutical Company) at 1200 micrograms (every 3 hours). Group B will also receive 200 micrograms of vaginal misoprostol (200 micrograms misoglandin tablet, Samisaz Pharmacy [Iran]). After 6 hours, both groups will be transferred to the operating room for the curettage. In the operating room, the cervical patency will be measured in millimeters using dilators.
Settings and conduct
A randomized single blind clinical trial study was performed in Golestan province, Gorgan, Sayad Shirazi Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Age> 35
• lack of sensitivity to trinitrate glycerin and misoprostol
• Absence of cardiovascular disease
• Hemoglobin level> 10 g / l
• Closure of the cervix
• Consent to participate in the study
Exclusion criteria:
• Abnormalities in patient’s test results including coagulation and CBC disorders
• Special medical conditions such as severe anemia, coagulation disorders, glaucoma, and bronchial asthma
PID presence ( endometritis , salpingitis ...) and vaginal infection
Intervention groups
All women referred to the clinic and maternity ward of Sayyed Shirazi Hospital with AUB complaint (abnormal bleeding) and candidates for diagnostic curettage during 2020
Main outcome variables
TNG and misoprostol effects on cervical ripening before diagnostic curettage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201105049276N1
Registration date:2020-11-10, 1399/08/20
Registration timing:registered_while_recruiting
Last update:2020-11-10, 1399/08/20
Update count:0
Registration date
2020-11-10, 1399/08/20
Registrant information
Name
Azam Amini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3226 1150
Email address
dr.aminichabok@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-14, 1399/07/23
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Glyceryl Trinitrate Versus Misoprostol for Cervical Ripening in Diagnostic Curettage, A single blind clinical trial study
Public title
Comparison of Glyceryl Trinitrate Versus Misoprostol for Cervical Ripening in Diagnostic Curettage
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Age > 35 years
No allergy history to Glyceryl Trinitrate and Misoprostol
Hb > 10 g/dl
Closure of the cervix
Consent to participate in the study
Exclusion criteria:
Abnormalities in patient’s test results including coagulation and CBC disorders
Special medical conditions such as severe anemia, coagulation disorders, glaucoma, and bronchial asthma
PID presence ( endometritis , salpingitis , ..) and vaginal infection
Age
From 35 years old
Gender
Female
Phase
3
Groups that have been masked
Care provider
Sample size
Target sample size:
168
Randomization (investigator's opinion)
Randomized
Randomization description
We use the block randomization method to randomize subjects into groups that result in equal sample sizes.
We use the block size 4. From the following blocks, first select 1 by accident and divide the samples into two groups according to the order and fill the blocks
A for intervention and B for placebo
B A B A 2) B B A A 1)
B A A B 4) A B B A 3)
A A B B 6) A B A B 5)
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is single-blind and the medical examiner resident and medication provider would not know about the type of treatment. After obtaining a detailed history, a complete physical examination, and checking CBC, BG and RH, as well as the cervical dilatation level from patients, will be determined before the drug administration.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Street address
Golestan University of Medical Sciences, Gorgan,Shastkola road, Philosophical Higher Education Complex
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2020-10-13, 1399/07/22
Ethics committee reference number
IR.GOUMS.REC.1399.224
Health conditions studied
1
Description of health condition studied
Cervical Ripening
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Ease of cervical ripening
Timepoint
6 Hours after administration
Method of measurement
Hegar Dilator size ( mm)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: TNG recipients will receive three doses of vaginal TNG (manufactured by Zahravi Pharmaceutical Company) at 1200 micrograms (every 3 hours)
Philosophical Higher Education Complex, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3220 2565
Email
dr.tabande@goums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Honarvar
Street address
Philosophical Higher Education, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1660
Fax
+98 17 3245 1657
Email
info@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
En Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Dr Azam Amini
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Golestan University of Medical Sciences, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3220 2565
Email
pfarjad13@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr Azam Amini
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Golestan University of Medical Sciences, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3220 2565
Email
pfarjad13@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr Azam Amini
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Golestan University of Medical Sciences, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3220 2565
Email
pfarjad13@gmail.com
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data, such as information about the main outcome or the like, can be shared.
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
It will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Use of data to complete the research process on the effects of using misoprostol and glycerin trinitrate (TNG) to cervix ripening for diagnostic curettage
From where data/document is obtainable
Contact the author of the article responsible for the research project data.
What processes are involved for a request to access data/document
Contact the author of the article responsible for the research project data.Specify the type of results requested.