Evaluation the efficacy of hyoscine on cervical dilation before hysteroscopy
Design
Randomized control open labeled trial of 100 patients based on random numbers table
Settings and conduct
This study will done among women who referred to Imam Hossein hospital and volunteer to participate in the study and are eligible to enter the study. First, the amount of cervical dilatation is evaluated using bogie number 4. Women who bogie number 4 does not pass through their cervix are divided into two groups of 42 people using a random number table. And 2 hours before the hysteroscopy operation, two hyoscine tablets (10 mg, manufactured by Porsina Pharmaceutical Company) are given to each patient intravaginally, and no intervention is done for the second group (control group). Then, on the day of the surgery, before the start of the surgery, the amount of cervical dilatation of both groups is re-evaluated using bogie number 4.
Participants/Inclusion and exclusion criteria
inclusion criteria:
Patient's willing
Menopausal women who are planned for hysteroscopy and dilator number 4 does not pass from cervix
Negative past cervical surgery
Negative allergy history about Hyoscine
Negative past medical history about cancers, obstructive bowel disease and cardiopulmonary disease
exclusion criteria:
Patient's non satisfaction
allergy to hyoscine
Intervention groups
intervention group is a candidate to receive vaginal hyoscine tablets. 2 hours before the hysteroscopy procedure, two hyoscine tablets (10 mg, manufactured by Porsina Pharmaceutical Company) are given to each patient intravaginally.
Main outcome variables
cervical dilation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220822055772N1
Registration date:2023-04-03, 1402/01/14
Registration timing:prospective
Last update:2023-04-03, 1402/01/14
Update count:0
Registration date
2023-04-03, 1402/01/14
Registrant information
Name
Hanieh Najafiarab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7758 2543
Email address
h_najafi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the efficacy of hyoscine on dilation of the cervix before hysteroscopy: an open-labeled randomized control trial
Public title
efficacy of hyoscine on dilation of the cervix
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient's willing to participate in study
Menopausal women who are planed for hysteroscopy and dilator number 4 does not pass from cervix
Negative past cervical surgery
Negative allergy history about Hyoscine
Negative past medical history about cancers, obstructive bowel disease and cardiopulmonary disease
Exclusion criteria:
not willing to participate in study
Sensitivity to hyoscine
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is a simple randomization that is done in the form of individual random units. The tool used to do this is a random numbers table. The method of constructing a random sequence is that first the researcher selects one of the numbers with his eyes closed and then moves in the right direction. Odd numbers are considered for intervention and even numbers are for control. Random concealment is also performed using sequentially numbered sealed opaque envelopes (SNOSE).
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
Ethics committees of School of Medicine - Shahid Beheshti University of Medical Sciences
Street address
School of medicine of Shahid Beheshti University of medical sciences, Koodakyar Ave., Daneshjoo Blvd,. Yaman St,. Chamran highway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-03-11, 1401/12/20
Ethics committee reference number
IR.SBMU.MSP.REC.1401.660
Health conditions studied
1
Description of health condition studied
Menopausal women
ICD-10 code
N95.9
ICD-10 code description
Unspecified menopausal and perimenopausal disorder
Primary outcomes
1
Description
cervical dilation
Timepoint
2 hours after medication
Method of measurement
bogie number 4
Secondary outcomes
1
Description
hyoscine side effect
Timepoint
after operation
Method of measurement
physician submission
Intervention groups
1
Description
Intervention group: The intervention group is candidate to receive hyosine vaginal tablets. 2 hours before the hysteroscopy procedure, two hyoscine tablets (10 mg, manufactured by Porsina Pharmaceutical Company) are given to each patient intravaginally.
Category
Treatment - Drugs
2
Description
Control group: There is no intervention for the control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hussein Hospital
Full name of responsible person
Hanieh Najafiarab
Street address
Imam Hossein Square, Shahid Madani Street, Tehran Province, Tehran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 3000
Email
haniye.najafiarab@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, No. 2, Arabi St., Yemen St., Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 9780
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hanieh Najafiarab
Position
Research Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Preventative Gynecology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7758 2543
Email
Haniye.najafiarab@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hanieh Najafiarab
Position
Research Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Preventative Gynecology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7758 2543
Email
Haniye.najafiarab@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hanieh Najafiarab
Position
Research Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Preventative Gynecology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7758 2543
Email
Haniye.najafiarab@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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