The purpose of this study is to investigate the effect of misoprostol and evening primrose oil on cervical dilatation before hysteroscopic surgeries.
Design
The clinical trial has a control group, with parallel groups, is double-blind, randomized, and is a phase 2 study that will be done on 120 patients.
Settings and conduct
In this clinical trial, 120 women referred to Kausar Medical Education Center located in Qazvin city are included in the study. The study population are women candidate for hysteroscopy who meet inclusion criteria. Using random allocation software, people are divided into two groups. In this study, both the surgeon and the patients do not know the type of drug used. For the purpose of blinding, 6 to 8 hours before hysteroscopy, the intended capsule is placed by the resident in the posterior fornix of the vagina. The removal of the prep and drape is done by another person, and if there is a vaginal pill, it will be removed so that the surgeon does not notice the presence of the vaginal pill and its type.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Menopausal women or women of reproductive age with no history of normal vaginal delivery (NVD); Closure of the cervix. Non-inclusion criteria: Women with cervical structural abnormalities and a history of cervical insufficiency; women with Müllerian malformations
Intervention groups
Intervention group: In the group receiving evening primrose oil, 2 500mg-capsules are placed in the posterior fornix of the vagina, 6 to 8 hours before hysteroscopy.
Control group: In the group receiving misoprostol, 2 mcg-capsules are placed in the posterior fornix of the vagina 6 to 8 hours before hysteroscopy.
Main outcome variables
Dilatation before hysteroscopy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230404057817N1
Registration date:2023-05-08, 1402/02/18
Registration timing:prospective
Last update:2023-05-08, 1402/02/18
Update count:0
Registration date
2023-05-08, 1402/02/18
Registrant information
Name
farkhondeh ghavampour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
kosarhospital284@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-05, 1402/03/15
Expected recruitment end date
2024-01-05, 1402/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of misoprostol and evening primrose oil on cervical dilatation before hysteroscopic surgery
Public title
The effects of evening primrose oil in preparing the cervix before hysteroscopic surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Menopausal women or women of reproductive age with no history of normal vaginal delivery (NVD)
Closure of the cervix
Exclusion criteria:
Women with cervical structural abnormalities and a history of cervical insufficiency
Women with Müller malformations
Women with a history of conization
Women with any contraindications to EPO or misoprostol (EPO or misoprostol contraindications such as seizures, asthma, high blood pressure, glaucoma, etc.)
Women who have a history of failed hysteroscopy or D&C due to severe cervical stenosis.
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Due to ease of use and saving time, the participants were divided into two groups using random sequence generation software. In this way, information such as the sample size and the number of groups is given to the software (Random allocation software) and the software provides a table of random numbers in which the letters A and B are randomly assigned to each number. In this study, numbers with letter A are in the intervention and numbers with letter B are in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double blind. In each of the groups, the desired capsule is placed in the posterior fornix of the vagina by the resident 6 to 8 hours before hysteroscopy. The surgeon and the patients will not know the type of drug used, and before the surgeon enters, the removal of the probe and the drape will be done by another person, and if there is a vaginal pill, the pill will be removed so that the surgeon does not notice the presence of the vaginal pill and its type.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Vice chancellor for research, Qazvin University of Medical Sciences, Shahid Bahonar blvd
City
Qazvin
Province
Qazvin
Postal code
3415613911
Approval date
2023-03-06, 1401/12/15
Ethics committee reference number
IR.QUMS.REC.1401.341
Health conditions studied
1
Description of health condition studied
Hysteroscopy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The time to reach the required dilatation (3 to 7 mm)
Timepoint
From the start of the operation until reaching the required expansion
Method of measurement
Clinical
Secondary outcomes
1
Description
Cervical rupture
Timepoint
Immediately after the patient regains consciousness
Method of measurement
Clinical observations
2
Description
Perforation of the uterus
Timepoint
Immediately after the patient regains consciousness
Method of measurement
Clinical observations
3
Description
Side effects
Timepoint
Immediately after the patient regains consciousness
Method of measurement
Clinical observations
Intervention groups
1
Description
Intervention group: In patients of this group, 2 capsules of 500 mg evening primrose oil ( Abidi Pharmaceutical Company) are placed in the posterior fornix of the vagina by the resident, 6 to 8 hours before hysteroscopy.
Category
Treatment - Drugs
2
Description
Control group: In patients of this group, 2 capsules of 200 micrograms of misoprostol (Samisaz Pharmaceutical Company) are placed in the posterior fornix of the vagina by the resident, 6 to 8 hours before hysteroscopy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Hospital
Full name of responsible person
Farkhondeh Ghavampour
Street address
Kosar Hospital, Taleghani St., Qazvin
City
Qazvin
Province
Qazvin
Postal code
34156-13176
Phone
+98 28 3323 6374
Email
mahdieghavampoor@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Seyed Mehdi Mirhashmi
Street address
Vice chancellor for research, Qazvin University of Medical Sciences, Shahid Bahonar blvd
City
Qazvin
Province
Qazvin
Postal code
3415613911
Phone
+98 28 3333 6001
Email
research.dpt@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Farkhondeh Ghavampour
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3413786313
Phone
+98 28 3333 6001
Email
mahdieghavampoor@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Venus Chegini
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kosar Hospital, Taleghani St., Qazvin
City
Qazvin
Province
Qazvin
Postal code
13176- 34156
Phone
+98 28 3323 6374
Email
mahdieghavampoor@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Farkhondeh Ghavampour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kosar Hospital, Taleghani St., Qazvin
City
Qazvin
Province
Qazvin
Postal code
13176- 34156
Phone
+98 28 3323 6374
Email
mahdieghavampoor@yahoo.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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
The collected information which is in the form of a questionnaire can be shared.
When the data will become available and for how long
The start of the access period is one year after the results are published.
To whom data/document is available
For obstetricians and researchers working in academic institutions
Under which criteria data/document could be used
Evaluate the path and process of study and analyze it
From where data/document is obtainable
For information, refer to Dr. Farkhondeh Ghavampour. The communication channels are as follows: By sending an email to the address: mahdieghavampoor@yahoo.com or referring and contacting Kosar Hospital at the address: Qazvin, Taleghani St. Phone: 028-33236374 Postal address: 34156-13176
What processes are involved for a request to access data/document
After sending the e-mail, the requested information will be reviewed by the facilitator and the person responsible for the scientific responsibility of the study. At your discretion, the requested information will be sent within 10 days of receiving the email