Comparison of the effect of Evening primrose oil with vaginal misoprostol in softening of the cervix in patients candidate for myomectomy hysteroscopy in Yas Hospital 2020-2022: a Randomized Clinical Trial
1. Comparison of Hegar dilator size used in Evening primrose oil group with misoprostol group
2. Determining the side effects caused by Evening primrose oil and misoprostol
Design
This phase 3 clinical trial with a control group, with parallel groups, double-blind, randomized using the Random allocation rule is performed on 118 patients.
Settings and conduct
In this randomized clinical trial study, which is performed on 118 patients who are candidates for myomectomy hysteroscopy in Yas Hospital from 2020 to 2022. The sampling method is a convenience method.
This study is performed as a double-blind study, the surgeon (the person performing the hysteroscopy) and the patient do not know the type of treatment. The drug is used by the resident physician for the patient based on the patient group the night before the hysteroscopy.
Participants/Inclusion and exclusion criteria
Inclusion criteria include all non-menopausal nulliparous women or gravid one women with a history of one cesarean section in the age group of 25 to 75 years.
Criteria for not entering:
Allergy or contraindication to Evening primrose oil or misoprostol
Intervention groups
In 59 patients 6 hours before hysteroscopy, for cervical ripening, two 500 mg Evening primrose oil capsules will be placed in the posterior part of the vagina, also, 200 micrograms of vaginal misoprostol will be used in the same way.
Main outcome variables
- Hegar dilator size used during hysteroscopy
- Time to dilatation after taking the drug
- Side effects following medication consumption
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201028049169N1
Registration date:2020-11-02, 1399/08/12
Registration timing:prospective
Last update:2020-11-02, 1399/08/12
Update count:0
Registration date
2020-11-02, 1399/08/12
Registrant information
Name
Elham Feizabad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8608 9092
Email address
elhamfeizabad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2022-11-21, 1401/08/30
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 vaginal misoprostol in softening of the cervix in patients candidate for myomectomy hysteroscopy in Yas Hospital 2020-2022: a Randomized Clinical Trial
Public title
Comparison of the effect of Evening primrose oil with vaginal misoprostol in softening of the cervix before myomectomy hysteroscopy in Yas Hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All non-menopausal nulliparous women or Gravid One women with a history of one cesarean section
The age group of 25 to 75 years
Exclusion criteria:
people with a history of schizophrenia or epilepsy taking phenothiazines, structural cervical abnormalities such as a history of cervical insufficiency, Müllerian anomaly, and history of conization
The unwillingness of people to participate in the study
Allergy to Evening primrose oil or misoprostol
contraindications for Evening primrose oil or misoprostol using such as coagulation disorders or concomitant consumption of anticoagulants drug
Age
From 25 years old to 75 years old
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
118
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation rule: First, 59 letters A and 59 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patient. In addition, interventions A or B are determined by a lot.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is performed as double-blind, the surgeon (the person performing the hysteroscopy), and the analyzer do not know the type of treatment. The drug is used by the resident physician for the patient based on the patient group the night before the hysteroscopy.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
ehran University of Medical Sciences,School of Medicine, Tehran Province, Tehran, Pour Sina St" to "Tehran University of Medical Sciences,School of Medicine, Tehran Province, Tehran, Pour Sina St
City
Tehran
Province
Tehran
Postal code
1598718311
Approval date
2020-10-12, 1399/07/21
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.611
Health conditions studied
1
Description of health condition studied
Uterine Leiomyoma
ICD-10 code
D25
ICD-10 code description
Leiomyoma of uterus
Primary outcomes
1
Description
The cervix dilatation measurement
Timepoint
Once, Before hysteroscopy
Method of measurement
The Hegar dilator size using for hysteroscopy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 6 hours before hysteroscopy for cervix ripening, 200 micrograms of vaginal misoprostol from Samisaz pharmaceutical company is placed in the posterior part of the vagina.
Category
Treatment - Drugs
2
Description
Control group: 6 hours before hysteroscopy for cervix ripening two 500 mg capsules of Evening primrose oil from Daana pharmaceutical company is placed in the posterior part of the vagina.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas hospital
Full name of responsible person
Mehrnaz Valadan
Street address
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8608 9089
Fax
Email
mehrnaz_valadan@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehrnaz Valadan
Street address
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8608 9089
Email
mehrnaz_valadan@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Sahar Garfami
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8608 9089
Email
sahar.garfami87@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehrnaz Valadan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8608 9089
Email
mehrnaz_valadan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elham Feizabad
Position
Researcher
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 8608 9089
Email
elhamfeizabad@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
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after unidentified participants
When the data will become available and for how long
After manuscript published
To whom data/document is available
No limitations
Under which criteria data/document could be used
The data is only available to the project manager, Dr. Valdan, and any analysis must be done with her opinion.
From where data/document is obtainable
Dr. Mehrnaz Valdan
What processes are involved for a request to access data/document
Any request must be made in writing and accompanied by a proposal with an ethics code under the supervision of Dr. Valdan.