A comparative study of the use of hyoscine and misoprostol in reducing complications caused by hysteroscopy
Design
This study is a phase III randomized control trial on 120 participants with two arms including misoprostol and hyoscine group. It is double blind. Randomization is based on Excel program. Demographic data of patients is recorded. hyoscine group get 20 milligrams of intramuscular ampule and the misoprostol group receive 200 microgram tablets vaginally.
Settings and conduct
The study is performed in Mahdie hospital, infertility ward. Cervical preparation is done 4 hours before the procedure and surgeon is not informed about each group, data is asked from the surgeon and analyzed.
Participants/Inclusion and exclusion criteria
All women candidate for hysteroscopy in Mahdie hospital between 1397-1399 entered the trial after filling the informed consent.
Exclusion criteria :
allergy to prostaglandins and hyoscine
previous cervicitis
cervical surgery or trauma
Intervention groups
No control group is identified in this study.
Misoprostol group received 200 micrograms tablets vaginally 3 hours before hysteroscopy.
Hyoscine group received an intramascular ampule 2 hours before the procedure.
Patient and surgeon are not aware of the drug.
Main outcome variables
post-op pain score; misoprostol or hyoscine side effects; uterine perforation; cervical lacerations;
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140224016705N13
Registration date:2022-11-05, 1401/08/14
Registration timing:retrospective
Last update:2022-11-05, 1401/08/14
Update count:0
Registration date
2022-11-05, 1401/08/14
Registrant information
Name
zahra heidar
Name of organization / entity
sbmu
Country
Iran (Islamic Republic of)
Phone
+98 21 4461 2416
Email address
dr_zheidar@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing injectable Hyoscine and vaginal misoprostol in cervical ripening before hysteroscopy
Public title
Hyoscine before hysteroscopy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All people who underwent hysteroscopy in Mahdieh Hospital
Exclusion criteria:
People who are allergic to prostaglandins or hyoscine.
People with a history of cervical injury or surgery.
People with active cervical infection.
Glaucoma
History of cardiovascular disease and tachycardia
People have recently been treated with estrogen.
pregnancy
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Individual simple randomization using rand function of Excel software
Every patient who is admitted to the hospital and placed in the hysteroscopy operation list is randomly assigned to one of the two groups of hyoscine or misoprostol using Excel software. Every day two to three people visit the hospital and they are allocated to the hyoscine or misoprostol category using randomization software
Blinding (investigator's opinion)
Double blinded
Blinding description
double blind study
the treatment or intervention is unknown to (a) the research participant, (b) the individual(s) who administer the treatment or intervention. A placebo intramuscular ampoule is also prescribed for the patients, and in the misoprostol group, a vaginal pill is inserted during the examination.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Koodakiar street, Shahid beheshti medical university
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-08-27, 1398/06/05
Ethics committee reference number
IR.SBMU.MSP.REC.1398.527
Health conditions studied
1
Description of health condition studied
cervical stenosis,
ICD-10 code
N88.2
ICD-10 code description
Stricture and stenosis of cervix uteri
2
Description of health condition studied
Endometrial polyp
ICD-10 code
N84.0
ICD-10 code description
Polyp of corpus uteri
Primary outcomes
1
Description
cervical lacerations rate
Timepoint
during hysteroscopy
Method of measurement
presence of lacerations or canals
2
Description
Entrance of hysteroscope into cervix
Timepoint
Start of hysteroscopy
Method of measurement
Likert scale
3
Description
Uterine perforations
Timepoint
During surgery
Method of measurement
Based on serum deficit or surgeon experience
4
Description
Post-op pain/ use of analgesics
Timepoint
for 24 hours after procedure
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
drug side effects
Timepoint
12 hours after drug administration
Method of measurement
based on patient vital signs and general conditions
Intervention groups
1
Description
Intervention group: Misoprostol.The people of this group are prescribed 200microgram of misoprostol single dose in the form of vaginal tablets on the morning of the surgery during the examination. cytotec misoprostol is prescribed in Mahdieh hospital.
Category
Prevention
2
Description
Intervention group: Hyoscine. These people are given a 20 mg ampoule of hyoscine purchased from Alborz daru company in the morning which is administered intramuscularly.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdie hospital
Full name of responsible person
Zahra heidar
Street address
Shoush square, shishegarkhane street
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
mahdiyeh_hospital@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Younes Panahi
Street address
Koodakiar street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9870
Email
urm@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
Dr. Zahra Heidar
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mahdieh Hospital
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 5506 6288
Fax
Email
dr_zheidar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Heidar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shoush square, Shishe gar khane street, Mahdie hospital
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 4461 2416
Fax
+98 21 5506 2627
Email
dr_zheidar@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Heidar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shoush square, Shishe gar khane street, Mahdie hospital
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 4461 2416
Fax
+98 21 5506 2627
Email
dr_zheidar@sbmu.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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Information about patient data that is included in the analysis and data about the main outcome can be shared.
When the data will become available and for how long
6 months after publication
To whom data/document is available
All academic and industrial researchers can access data.
Under which criteria data/document could be used
metanalysis could be done on our data.
From where data/document is obtainable
Applicants must send an e-mail in English stating the reason for using the data and the type of analysis. The email will be answered within 10 working days and the information file will be made available to them.
What processes are involved for a request to access data/document
An email will be sent in English stating the reason for using the data and the type of analysis and will be answered within 10 working days.