The purpose of this study is to evaluate the effect of oral administration of crocin tablet on cervical readiness in women who are candidates for hysteroscopy.
Design
A two-blind randomized clinical trial with a parallel group design of 50 patients, enrolled between October 2018 and October 2019
Settings and conduct
The setting of the study is the Gynecology ward and the operating room of Rasoul-e-Akram Hospital. First, pelvic exam is done for each patient candidate for hysteroscopy. Then a concealed enclosed envelope is given to the patient by a third person not invloved in the study which includes 4 tablets to ingest orally two of them the evening and two of them the night before operation. The patients and the surgeon are blind to the tablets.The morning of surgery repeat exam is done. Then entering dilators from the least diameter to the maximum diameter passed from cervical canal without resistance is performed. َAll the information is documented in the questionnaires.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All women who are candidates for operative hysteroscopy, Having written informed consent for using the cervical ripening agent, Having no allergy to saffron or prostaglandins ,
Exclusion criteria: Suffering from active hepatic, renal, hematologic and or cardiologic disorder, Suffering from approved malignancy of the genital tract ,
Approved cervical insufficiency
Intervention groups
Intervention group: Two oral crocin 15 mg tablets (Krocina tablet produced by Sami Saz Co., Mashhad) will be prescribed to patients at 6 pm and two at 12 midnight before the surgery.
Control group: Two misoprostol tablets (CYTOTEC 100 μg,
Pfizer Co.) will be prescribed to patients at 6 pm and two at 12 midnight before the surgery.
Main outcome variables
The extent of cervical canal dilatation before the onset of hysteroscopy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150909023949N9
Registration date:2018-11-24, 1397/09/03
Registration timing:prospective
Last update:2018-11-24, 1397/09/03
Update count:0
Registration date
2018-11-24, 1397/09/03
Registrant information
Name
Mansoureh Vahdat
Name of organization / entity
Iran University of medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9283
Email address
vahdat.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-05, 1397/10/15
Expected recruitment end date
2019-11-06, 1398/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effects of crocin and misoprostrol consumption on cervical ripening in women undergoing operative hysteroscopy: a randomised clinical trial
Public title
Comparing crocin and misoprostol effects on cervical ripening
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All women who are scheduled for operative hysteroscopy
No history of allergy to saffron or prostaglandins
Having written informed consent
Exclusion criteria:
Suffering from active hepatic, renal, hematologic or cardiologic disorder
Approved known malignancy of genital tract
Approved cervical insufficiency
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 50 women who are candidates for hysteroscopy will be divided into two groups of control and case (25 each).Using a table of random numbers, a number from 1 to 50 is attributed to each patient. Crocin tablets will be given to odd numbers as the case group and misoprostol tablets will be given to even numbers as the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients receiving the tablets and the surgeon performing the hysteroscopy are blind to the study. Tablets put in enclosed opaque envelopes will be numbered َA or B and will be given to patients by a third person unaware of the study.
Placebo
Not used
Assignment
Parallel
Other design features
Iran is considered one of the main countries which export saffron, therefore, any study highlighting the value of this herb in medicine could be of significant importance in improving the economic conditions of the society. This would be the first study which assess the effects of one of the main constituents of saffron on cervical softening which could have desirable outcomes in the minimally invasive surgical procedures used in the gynecology field
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Rasoul-e-Akram Hospital, Maziar Mansouri Street, Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Approval date
2018-08-26, 1397/06/04
Ethics committee reference number
IR.IUMS.REC.1397.232
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 glandular hyperplasia
3
Description of health condition studied
submucosal 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
ICD-10 code description
5
Description of health condition studied
excessive bleeding in the premenopausal period
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Size of the largest dilator passed from cervical canal without resistance
Timepoint
After the induction of the anesthesia and before entering the hysteroscope in the operating room
Method of measurement
examination performed by the surgeon- Using standard dilators in the operating room
Secondary outcomes
1
Description
The extent of cervical tissue softening
Timepoint
After induction of anesthesia and before entering the hysteroscope in the operating room
Method of measurement
examination by the surgeon in the operating room
2
Description
The length of time of the procedure till entering the uterine cavity
Timepoint
After induction of anesthesia in the operating room
Method of measurement
Using chronometer by the surgeon's assistant
Intervention groups
1
Description
Intervention group: Two crocin 15 mg tablets (Sami Saz Co. mashhad) are given to patients at 6 pm and 12 midnight before surgery.
Category
Treatment - Drugs
2
Description
Control group: Two misoprostol 100 microgram (CYTOTEC ,Pfizer Co.) tablets are given at 6 pm and 12 midnight before surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul-e-Akram Hospital
Full name of responsible person
Mansoureh Gorginzadeh
Street address
Rasoul-e-Akram Hospital, Mazar-i-Mansouri St., Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2562
Email
inf.erc@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazem Malakouti
Street address
Iran University of Medical Science, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
malakoutik@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mansoureh Vahdat
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasoul-e-Akram Hospital, Niayesh St., Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2562
Email
vahdat.m@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mansoureh Vahdat
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasoul-e-Akram Hospital, Niayesh St., Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2562
Email
vahdat.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mansoureh Gorginzadeh
Position
Fellowship of minimally invasive surgery
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasoul-e-Akram Hospital, Niayesh St., Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2562
Email
mansourehgorginzadeh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD