Determination of the effect of intracervical injection of hyoscine on cervical dilatation in patients with cervical stenosis under hysteroscopy.
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 96 patients. The rand function of Excel software was used for randomization.
Settings and conduct
This study will be conducted in the Al-Zahra Hospital. At the beginning of hysteroscopy, an attempt will be made to pass the hysteroscope through the cervix. If dilator number 2 does not enter the patient's cervix, it will be considered as cervical stenosis, then the patients will be randomly assigned to One by one, they will enter the studied groups (hyosin-distilled water). Then, after 3 minutes, another attempt will be made to pass dilator number 2, and then in order to pass larger dilators through the cervical canal.
Participants/Inclusion and exclusion criteria
Inclusion criteria: healthy women aged 20-65 without systemic disease, candidates for hysteroscopy with possibility of cervical stenosis.
Exclusion criteria include history of sensitivity to hyoscine, severe systemic disease.
Intervention groups
The intervention group injected half a cc of hyoscine in each of the 4 and 8 hours of the cervical stroma
The control group injected half a cc of distilled water in each cervical stroma at 4 and 8 hours
Main outcome variables
Comparing the frequency of passage of dilator with size 6 passed through the cervical canal after intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220703055355N1
Registration date:2022-08-22, 1401/05/31
Registration timing:registered_while_recruiting
Last update:2022-08-22, 1401/05/31
Update count:0
Registration date
2022-08-22, 1401/05/31
Registrant information
Name
Sara Farzadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 9224
Email address
sarafarzadi800@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-22, 1401/04/31
Expected recruitment end date
2024-07-21, 1403/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hyoscine on cervical dilatation in patients with cervical stenosis under hysteroscopy
Public title
The survey of hyoscine on cervical dilatation in patients with cervical stenosis under hysteroscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy married women aged 20-65 without systemic disease who are candidates for hysteroscopy
Women with the possibility of cervical stenosis, such as postmenopausal women, women with no history of normal vaginal delivery, women with a history of cesarean section, nulliparous women who appear to have cervical stenosis during examination, and infertile women who have cervical stenosis in hysterosalpingography.
Exclusion criteria:
History of sensitivity to hyoscine
Having cardiovascular disease
Having hypertension
having glaucoma
having porphyria
Having digestive problems (reflux, diarrhea, constipation, peptic ulcer)
Having severe systemic disease
Having a genital infection
Having an abnormal discharge
Having an abnormal pap smear
Taking hormonal drugs
Conization history
Age
From 20 years old to 65 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Random sequences will be generated using the Random generator program. It will be produced based on the method of random blocks and considering blocks of four. After generating the list, each person will be assigned a unique code and will be identified with this code during the study. Allocation concealment will be done using sealed envelopes (SNOSE). Based on the size of the research sample, several aluminum envelopes will be prepared and each of the randomly generated sequences will be placed on a registered card and the cards will be placed in the envelopes in order. In order to maintain the random sequence, the outer surface of the envelopes will be numbered in the same order. Finally, the lid of the envelopes will be glued and will be placed in a box respectively. At the start of the intervention, the envelopes are opened in order and the assigned group of that participant is revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, none of the participants and the surgeon will be aware of the randomization list, and to conceal the randomization process, the sealed envelopes prepared by the supervisor of the operating room and numbered in sequence, The use and envelope related to each person will be opened only after confirming the eligibility criteria for entering the study and signing the consent form by the person.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Gilan University of Medical Sciences
Street address
University Research and Technology Vice-Chancellor, Namjoo St.,
City
Rasht
Province
Guilan
Postal code
1234567890
Approval date
2022-07-13, 1401/04/22
Ethics committee reference number
IR.GUMS.REC.1401.221
Health conditions studied
1
Description of health condition studied
Other abnormal uterine and vaginal bleeding
ICD-10 code
N93.9
ICD-10 code description
Abnormal uterine and vaginal bleeding, unspecified
Primary outcomes
1
Description
Comparing the frequency of passage without resistance of dilator number 6 through the cervix after three minutes through the cervical canal
Timepoint
3 minutes after the start of the intervention
Method of measurement
Passing dilator number 6 through the cervix without resistance
Secondary outcomes
1
Description
Comparison of the size frequency of the largest dilator passed through the cervical canal
Timepoint
3 minutes after intervention
Method of measurement
Passing the dilator through the cervical canal
2
Description
Comparison of the average length of hysteroscopy operation
Timepoint
After completion of hysteroscopy
Method of measurement
Time in minutes
3
Description
Comparison of the frequency of complications of hysteroscopy
Timepoint
After completion of hysteroscopy
Method of measurement
check list
4
Description
The frequency of complications of the drug Hyosin
Timepoint
One day after hysteroscopy
Method of measurement
check list
Intervention groups
1
Description
Intervention group: injection of half cc of hyoscine into the cervical stroma at 4 and 8 hours
Category
Treatment - Drugs
2
Description
Control group: injection of half cc of distilled water into the cervical stroma at 4 and 8 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Sara Farzadi
Street address
Al-Zahra Hospital, Namjoo st
City
Rasht
Province
Guilan
Postal code
4144654839
Phone
+98 13 3336 9224
Email
sara_farzadi800@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Reza Naghipour
Street address
Vice Chancellor of Research and Technology, Namjoo st
City
Rasht
Province
Guilan
Postal code
6789012345
Phone
+98 13 3333 6394
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Sara Farzadi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Al-Zahra Hospital, Namjoo St
City
Rasht
Province
Guilan
Postal code
4144654839
Phone
+98 13 3336 9224
Email
sara_farzadi800@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Sara Farzadi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Al-Zahra Hospital, Namjoo St
City
Rasht
Province
Guilan
Postal code
4144654839
Phone
+98 13 3336 9224
Email
sara_faezadi800@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Sara Farzadi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Al-Zahra Hospital, Namjoo St
City
Rasht
Province
Guilan
Postal code
4144654839
Phone
+98 13 3336 9224
Email
sara_farzadi800@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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
It has not been planned yet.
From where data/document is obtainable
sara_farzadi800@gmail.com
What processes are involved for a request to access data/document