The effectiveness of vaginal Evening primrose oil gel Capsule on the ease of Cervical Ripening
Design
A clinical trial with a control group; with parallel groups; double-blinded; 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 Hazrat Zeinab Hospital in Shiraz, 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
Inclusion criteria: Women candidates for hysteroscopy, 18-50 years old, non-pregnant, who have no history of natural childbirth or cervical manipulation, have spinal anesthesia and are satisfied with the participation. Exclusion criteria:
contraindicated to use prostaglandins; history of molar cervical anomalies or history of a cervical biopsy; Patients receiving general anesthesia; BMI> 35
Intervention groups
In the gynecology ward of Hazrat Zeinab Hospital in Shiraz, 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.
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:IRCT20140525017827N12
Registration date:2021-08-23, 1400/06/01
Registration timing:registered_while_recruiting
Last update:2021-08-23, 1400/06/01
Update count:0
Registration date
2021-08-23, 1400/06/01
Registrant information
Name
Nasrin Asadi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 2365
Email address
asadin@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Primrose oil gel capsule on the Ease of Cervical Ripening Before Operative Hysteroscopy
Public title
Effect of eveing primrose oil in ripening of cervix before of gynecologic surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for hysteroscopy
Aged 18-50 years
No pregnancy
Consent to participate in the study
Women who do not have a history of normal delivery or cervical manipulation
Spinal anesthesia
nulliparity
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.
History of cervical incompetence Mullerian anomaly or a history of a cervical cone biopsy,
General anesthesia
BMI>35
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Misoprostol and primrose oil gel capsules are the same appearance and characteristics and will be given to our colleague drug distributor in the form of A or B. 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. The patients, researcher, and 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
100 patients with incomplete abortion will be studied in two groups of 50. Patients will receive A or B medication based on randomized block in double blind method and a code will be allocated to each patient (1 to 100) that will be encoded at the end of the study. The patients and the designer and drug distributer are not aware of the drug pack. This study is the second phase of trial
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Headquarters Of Shiraz University of Medical Sciences - Zand St - Shiraz
City
Shiraz
Province
Fars
Postal code
34786-71946
Approval date
2020-07-14, 1399/04/24
Ethics committee reference number
IR.SUMS.REC.1399.685
Health conditions studied
1
Description of health condition studied
Cervical preparation before hysteroscopic surgery
ICD-10 code
N84.0
ICD-10 code description
Polyp of corpus uteri
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: 2 capsules of evening primrose 1000 mg (made by webber naturals Canada with confirmation code 1505809997164877771629, UID: 15210012004109455083 and GTN: 062600847248841 Food: LOT: 1 The vagina is placed behind the fornix 4-6 hours before surgery.
Category
Treatment - Drugs
2
Description
Intervention group: 400 micrograms of misoprostol ( Pfizer company) 4-6 hours before surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazat Zeinabeh Hospital of Shiraz University of Medical Science