Comparison of the effect of Evening primrose oil with Misoprostol on cervical ripening before hysteroscopy in women without a previous vaginal delivery. A double-blind clinical trial
Comparison of the effect of Evening primrose oil with Misoprostol on cervical ripening before hysteroscopy in women without a previous vaginal delivery
Design
A clinical trial with a control group; with parallel groups; double blind clinical trial; randomized; design of 100 patients; phase 3
Settings and conduct
For patients of both groups, the relevant questionnaires are completed before the start of the study. In the gynecology ward of Alzahra Hospital in Tabriz, medications are prescribed 4-6 hours before vaginal surgery (in the intervention group of evening primrose oil and in the control group of misoprostol). And the side effects of drugs are checked before, during and after the hysteroscopic operation and the general duration of cervical dilatation and the general duration of surgery and cervical dilatation and softness are checked .
Participants/Inclusion and exclusion criteria
Women candidates for hysteroscopy, 18-50 years old, non-pregnant, who have no history of natural childbirth or cervical manipulation, will be enter the study.Patients who have a history of history of molar cervical anomalies or history of a cervical biopsy will be prohibited from entering the study.
Intervention groups
Intervention group: 1 capsules of evening primrose 1000 mg (made by Dana Pharma company)The vagina is placed behind the fornix 4-6 hours before surgery. Control group:200 micrograms of misoprostol ( Behestan Daru Company) 4-6 hours before surgery.
Main outcome variables
Complications of the drug before, during and after hysteroscopy; Cervical consistency; Cervical dilatation; Total duration of cervical dilatation; The total duration of surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220930056059N2
Registration date:2022-12-28, 1401/10/07
Registration timing:prospective
Last update:2022-12-28, 1401/10/07
Update count:0
Registration date
2022-12-28, 1401/10/07
Registrant information
Name
Maryam Vaezi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3556 1831
Email address
mva260@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-31, 1401/10/10
Expected recruitment end date
2023-12-31, 1402/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Evening primrose oil with Misoprostol on cervical ripening before hysteroscopy in women without a previous vaginal delivery. A double-blind clinical trial
Public title
Comparison of the effect of Evening primrose oil with Misoprostol on cervical ripening before hysteroscopy in women without a previous vaginal delivery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women candidates for hysteroscopy
Candidate for hysteroscopy Aged 25-75 years
non-pregnant
The patient consent to participate in the study
Who have no history of natural childbirth or cervical manipulation
Exclusion criteria:
Those who had a contraindication to PGs (history of severe asthma, glaucoma, preexisting cardiac disease, hypertension, or renal failure, bleeding disorders or consuming medications that inhibit blood clotting
Patients with a history of schizophrenia who take phenothiazines
patients with epilepsy and seizure
Significant uterovaginal prolapse precluding the administration of vaginal tablets
Age
From 25 years old to 75 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The treatment allocation list is already designed on Block Balanced Randomization Method by the computer software. 1 (A), 2 (B), 3 (B), 4 (B), 5 (A),……. Any eligible patient will be given a 1 to 100 code after obtaining informed consent in order to visit the clinic and based on the above block, they receive A or B drug. The drug distributor doesn’t have a role in the treatment plan and data analysis.Data analyzer are not aware of the type of treatment for each patient. Finally, the patients will be followed by their own codes
Blinding (investigator's opinion)
Double blinded
Blinding description
Outcome assessors and data analysts will not have information on how to assign groups to patients in groups A and B. We divide the outcome assessor and the patient data analyzer into A and B know and do not know the nature of groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Tabriz University Of Medical Sciences
Street address
Third Floor; Central Building of Number2; Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2022-11-14, 1401/08/23
Ethics committee reference number
IR.TBZMED.REC.1401.736
Health conditions studied
1
Description of health condition studied
Leiomyoma of uterus
ICD-10 code
D25
ICD-10 code description
Leiomyoma of uterus
Primary outcomes
1
Description
Size of first input hegar dilator
Timepoint
At the beginning of the study and immediately after the hysteroscopy (4-6 hours after taking the drug)
Method of measurement
Measurement of cervical dilatation: Hegar dilator
Secondary outcomes
1
Description
Complications of the drug before, during and after hysteroscopy
Timepoint
After prescribing the drug (4-6 hours later) and immediately before the hysteroscopic surgery and during the operation
Method of measurement
Clinical observation
2
Description
Cervical consistency after drug administration
Timepoint
After prescribing the drug (4-6 hours later) and immediately before the hysteroscopic surgery and during the operation
Method of measurement
Check the consistency of the cervix with a finger examination, Hegar Dilator
3
Description
Duration of cervical dilatation
Timepoint
After prescribing the drug (4-6 hours later) and immediately before the hysteroscopic surgery and during the operation
Method of measurement
Timing
4
Description
The total duration of surgery
Timepoint
During the operation
Method of measurement
Timing
Intervention groups
1
Description
Intervention group: 1 capsules of evening primrose 1000 mg (made by Dana Pharma company)is inserted in the posterior fornix 4 to 6 hours before surgery.
Category
Treatment - Drugs
2
Description
Control group:200 micrograms of misoprostol ( Behestan Daru Company) is inserted in the posterior fornix 4 to 6 hours before surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr.Maryam Vaezi
Street address
Alzahra Hospital, South Artesh St.,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
mva260@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Parviz Shahabi
Street address
No. 2 Central Building,Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Maryam Vaezi
Position
Associate Professor of Obstetrics Gynecology
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3551 9161
Email
mva260@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Maryam Vaezi
Position
Associate professor of Obstetrics Gynecology
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 35519161
Email
mva260@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Maryam Vaezi
Position
Associate professor of Obstetrics Gynecology
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 35519161
Email
mva260@yahoo.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