Comparison of sublingual nitroglycerin and misoprostol on cervical ripening before hysteroscopy.
Design
This is a double-blind randomized clinical trial, in which 84 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
This study will be conducted at Hazrat Rasool Akram Hospital, where patients will provide written consent by signing and dating the consent form. The degree of cervical preparation will be measured using a graduated dilator in two groups of patients who will receive either nitroglycerin or misoprostol. The study will be double-blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 18-50 years (reproductive age), history of at least one Normal Vaginal Delivery, and being a candidate for hysteroscopy.
Exclusion criteria: history of drug allergy and cardiovascular diseases.
Intervention groups
Intervention group 1: 42 patients under general anesthesia receive nitroglycerin (Zahrawi Company, Iran) at a dosage of 0.4 mg sublingually 30 minutes before the operation.
Intervention group 2: 42 patients receive misoprostol tablets (manufactured by Zahrawi Pharmaceutical Company) at a dosage of 200 micrograms sublingually 6 hours before surgery.
Main outcome variables
Cervical dilatation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191123045476N4
Registration date:2023-09-01, 1402/06/10
Registration timing:registered_while_recruiting
Last update:2023-09-01, 1402/06/10
Update count:0
Registration date
2023-09-01, 1402/06/10
Registrant information
Name
Samaneh Rokhgireh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9283
Email address
rokhgireh.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-20, 1402/03/30
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effect of sublingual Nitroglycerin and sublingual Misoprostol on Cervical ripening before Hysteroscopy
Public title
Investigating nitroglycerin and misoprostol on cervical ripening
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 18-50 years (reproductive age)
history of at least one Normal Vaginal Delivery
being a candidate for hysteroscopy
Exclusion criteria:
history of drug allergy
cardiovascular diseases
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the main researcher and the data analyst will be blinded to the assignment of the study groups; The patients are given a special code and the analyst does not know which group A and B are, and the main researcher is not involved in the selection of patients and does not know which group the patient who is undergoing surgery belongs to.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of medical sciences, Hammat highway, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Approval date
2023-05-28, 1402/03/07
Ethics committee reference number
IR.IUMS.REC.1402.180
Health conditions studied
1
Description of health condition studied
Hysteroscopy candidate patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Cervical dilatation
Timepoint
Immediately after taking the drug during surgery
Method of measurement
In the operating room, the opening of the cervix is measured in millimeters using sized dilators.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: 42 patients under general anesthesia receive sublingual nitroglycerin (Zahrawi Company, Iran) at a dosage of 0.4 mg 30 minutes before the operation.
Category
Treatment - Drugs
2
Description
Intervention group 2: 42 patients receive misoprostol tablets (manufactured by Zahrawi Pharmaceutical Company) at a dosage of 200 micrograms sublingually 6 hours before surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Samaneh Rokhgireh
Street address
Rasoul Akram Hospital, Mansouri Street, Starkhan, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
s.rokhgireh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Falak
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 8670 2503
Email
Falak.r@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
Samaneh Rokhgireh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasoul Akram Hospital, Mansouri Street, Starkhan, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6650 9283
Fax
Email
Rokhgireh.s@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samaneh Rokhgireh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasoul Akram Hospital, Mansouri Street, Starkhan, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6650 9283
Fax
Email
Rokhgireh.s@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samaneh Rokhgireh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasoul Akram Hospital, Mansouri Street, Starkhan, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6650 9283
Fax
Email
Rokhgireh.s@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
After the article is published, confidential information such as patient and hospital details will be removed and other information will be provided to the researchers.
When the data will become available and for how long
After publishing the article
To whom data/document is available
Medical specialists
Under which criteria data/document could be used
Medical professionals can access the data for research purposes.
From where data/document is obtainable
Refer to the email of the responsible author.
What processes are involved for a request to access data/document
Official and academic email to the responsible author