Determination and comparison of the effect of vaginal hyoscine butyl bromide with vaginal misoprostol on cervical ripening before hysteroscopy
Design
A randomized, controlled, double-blind, placebo-controlled clinical trial
Settings and conduct
Patients in Imam Ali Hospital in Zahedan will be randomly divided into two groups. Eligible patients will be randomly divided into two groups after explaining the aims and conditions of the study and obtaining informed consent. A, B will be coded, and the patient and the patient's clinical caregiver (patient physician) will not be informed of the patient allocation to the study groups. So the study will be double-blind. The plan is to carry out the general anesthesia with a mask. Anesthetic drugs are provided under the anesthesia service. After general anesthesia with the mask, the patient is placed in a speculum lithotomy position. If the cervical opening is open the bogey number 5 will be rejected and will be affected and if the open is not opened, other bogeys will be used as needed.
Participants/Inclusion and exclusion criteria
All women candidates for hysteroscopy aged 18-65 years are not allergic to prostaglandins and hyoscine. They have no history of taking antihypertensive drugs, cardiovascular disease, asthma, glaucoma and will excluded if they do not consent to continue the treatment process.
Intervention groups
The first group receiving hyoscine butyl bromide: This drug will be given vaginally at a dose of 20 mg (2 tablets 10 mg) 4 hours before surgery. Group II Misoprostol recipients: this drug will be given vaginally at a dose of 200 μg 4 hours before surgery.
Main outcome variables
Frequency of Dilator Hagar passage number 5; Duration of surgery in two groups; Severity of pain before and after half an hour in both groups; Side effects; Cervical rippening readiness before hysteroscopy in both groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190929044920N1
Registration date:2019-12-07, 1398/09/16
Registration timing:registered_while_recruiting
Last update:2019-12-07, 1398/09/16
Update count:0
Registration date
2019-12-07, 1398/09/16
Registrant information
Name
Mahboubeh Borna
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5570
Email address
dr.bornamah@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of vaginal hyoscine butyl bromide and vaginal misoprostol on cervical ripening before hysteroscopy
Public title
The effect of vaginal hyoscine butyl bromide on cervical ripening before hysteroscopy
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Women candidates for hysteroscopy
Age between 18-65 years
Exclusion criteria:
Dissatisfaction with continuing treatment process
Sensitivity to the drugs used
Asthma
Glaucoma
cardiovascular disease
Taking antihypertensive drugs
Sensitivity to prostaglandins
Age
From 18 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly blocked with 4 person blocks
Blinding (investigator's opinion)
Double blinded
Blinding description
Medicines will be coded A, B, and the patient and the clinical caregiver (patient physician) will not be informed of the patient's assignment to the study groups. So the study will be double-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Ali Ebn Abitaleb Hospital, Persian Gulf Expressway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2019-07-28, 1398/05/06
Ethics committee reference number
IR.ZAUMS.REC.1398.235
Health conditions studied
1
Description of health condition studied
Uterine polyp
ICD-10 code
N84.0
ICD-10 code description
Polyp of corpus uteri
2
Description of health condition studied
endometrial hyperplasia
ICD-10 code
N85.0
ICD-10 code description
Endometrial hyperplasia
3
Description of health condition studied
Submucousal fibroid
ICD-10 code
D25.0
ICD-10 code description
Submucous leiomyoma of uterus
4
Description of health condition studied
Abnormal uterine bleeding
ICD-10 code
N93.9
ICD-10 code description
Abnormal uterine and vaginal bleeding, unspecified
5
Description of health condition studied
Noninflammatory disorder of uterus, unspecified
ICD-10 code
N85.9
ICD-10 code description
Noninflammatory disorder of uterus, unspecified
6
Description of health condition studied
Patients who are candidates for hysteroscopy
ICD-10 code
N71.9
ICD-10 code description
Inflammatory disease of uterus, unspecified
Primary outcomes
1
Description
Frequency of Dilator Hagar Crossings No. 5
Timepoint
After complete anesthesia
Method of measurement
Hagar Number Five Crossing
2
Description
Duration of operation time
Timepoint
Duration of operation
Method of measurement
Stopwatch
3
Description
Side effects
Timepoint
From medication to discharge
Method of measurement
Complete patient examination
4
Description
Severity of pain
Timepoint
During surgery and half an hour after surgery
Method of measurement
The visual acuity scale (VAS) zero to ten
5
Description
Cervical dilatation rate
Timepoint
Check in operation
Method of measurement
Based on measurements by Hegar and hysteroscopes
Secondary outcomes
1
Description
Duration of operation time
Timepoint
Duration of operation
Method of measurement
Stopwatch
2
Description
Side effects
Timepoint
From medication to discharge
Method of measurement
Complete patient examination
3
Description
Severity of pain
Timepoint
During surgery and half an hour after surgery
Method of measurement
The visual acuity scale (VAS) zero to ten
4
Description
Cervical dilatation rate
Timepoint
Check in operation
Method of measurement
Based on measurements by Hegar and hysteroscopes
Intervention groups
1
Description
Hyosine Butyl Bromide Recipient: This drug will be given vaginally at a dose of 20 mg (2 tablets 10 mg) 4 hours before surgery.
Category
Diagnosis
2
Description
Misoprostol recipient: This drug will be given vaginally at a dose of 200 μg 4 hours before surgery.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ibn Abi Taleb Hospital
Full name of responsible person
Mahbubeh Borna
Street address
Persian Gulf Highway, Salamat Blvd., Ali Ibn Abi Taleb Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5570
Email
dr.mahbobehbrn@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Noor Mohammad Bakhshani
Street address
Deputy of Research and Technology, Student Scientific Research Center, University of Medical Sciences campus, Dr. Hesabi Square, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Email
Msrc@zamus.ac.ir
Web page address
http://msrc.zaums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Mahboubeh Borna
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ali Ibn Abi Talib Hospital, Slamat Blvd., Persian Gulf Highway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Fax
Email
dr.bornamah@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mahboubeh Borna
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ali Ibn Abi Talib Hospital, Slamat Blvd., Persian Gulf Highway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Fax
Email
dr.bornamah@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mahboubeh Borna
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ali Ibn Abi Talib Hospital, Slamat Blvd., Persian Gulf Highway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Fax
Email
dr.bornamah@zaums.ac.ir
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
Not applicable
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