Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
General information
empty
Enter a no entry criterion
Enter a no entry criterion
empty
وارد کردن یک معیار عدم ورود
وارد کردن یک معیار عدم ورود
People who need laparoscopy
Pregnant women
Existence of systemic diseases
infection of cervix
Existence of cervical anomalies
Existence of Mullerian anomalies
Contraindication prostaglandins.
patients with bleeding disorders
consumers of anticoagulants
patients with schizophrenia who use phenothiazine
patients With epilepsy
patients With blood pressure
People who need abdominal hysterectomy
infection of vaginal
Existence of cervical insufficiency
Existence of history of cervical biopsy
cesarean delivery
People who need laparoscopy
Pregnant women
Existence of systemic diseases
infection of cervix
Existence of cervical anomalies
Existence of Mullerian anomalies
Contraindication prostaglandins.
patients with bleeding disorders
consumers of anticoagulants
patients with schizophrenia who use phenothiazine
patients With epilepsy
patients With blood pressure
People who need abdominal hysterectomy
infection of vaginal
Existence of cervical insufficiency
Existence of history of cervical biopsy
cesarean delivery
History of allergies to evening primros
People who need laparoscopy Pregnant women Existence of systemic diseases infection of cervix Existence of cervical anomalies Existence of Mullerian anomalies Contraindication prostaglandins. patients with bleeding disorders consumers of anticoagulants patients with schizophrenia who use phenothiazine patients With epilepsy patients With blood pressure People who need abdominal hysterectomy infection of vaginal Existence of cervical insufficiency Existence of history of cervical biopsy cesarean delivery History of allergies to evening primros
افرادی که نیاز به لاپاراسکوپی دارند
زنان باردار
وجود بیماریهای سیستمیک
وجود عفونت سرویکس
وجود آنومالیهای سرویکس
وجود آنومالیهای مولرین
ممنوعیت مصرف پروستاگلاندینها
بیماران مبتلا به اختلالات خونریزی
مصرفکنندگان داروهای ضد انعقادی
بیماران مبتلا به اسکیزوفرنی که فنوتیازین استفاده مینمایند
بیماران مبتلا به صرع
بیماران مبتلا به فشار خون
افرادی که نیاز به هیسترکتومی شکمی دارند
وجود عفونت واژن
وجود نارسایی سرویکس
وجود سابقه بیوپسی از سرویکس
زایمان سزارین
افرادی که نیاز به لاپاراسکوپی دارند
زنان باردار
وجود بیماریهای سیستمیک
وجود عفونت سرویکس
وجود آنومالیهای سرویکس
وجود آنومالیهای مولرین
ممنوعیت مصرف پروستاگلاندینها
بیماران مبتلا به اختلالات خونریزی
مصرفکنندگان داروهای ضد انعقادی
بیماران مبتلا به اسکیزوفرنی که فنوتیازین استفاده مینمایند
بیماران مبتلا به صرع
بیماران مبتلا به فشار خون
افرادی که نیاز به هیسترکتومی شکمی دارند
وجود عفونت واژن
وجود نارسایی سرویکس
وجود سابقه بیوپسی از سرویکس
زایمان سزارین
سابقه حساسیت به مصرف گل مغربی
افرادی که نیاز به لاپاراسکوپی دارند زنان باردار وجود بیماریهای سیستمیک وجود عفونت سرویکس وجود آنومالیهای سرویکس وجود آنومالیهای مولرین ممنوعیت مصرف پروستاگلاندینها بیماران مبتلا به اختلالات خونریزی مصرفکنندگان داروهای ضد انعقادی بیماران مبتلا به اسکیزوفرنی که فنوتیازین استفاده مینمایند بیماران مبتلا به صرع بیماران مبتلا به فشار خون افرادی که نیاز به هیسترکتومی شکمی دارند وجود عفونت واژن وجود نارسایی سرویکس وجود سابقه بیوپسی از سرویکس زایمان سزارین سابقه حساسیت به مصرف گل مغربی
Protocol summary
Study aim
Determining the efficiency of evening Primrose Oil on operative hysteroscopy
Design
Clinical trial with control group, with parallel groups, double blind, randomized
Settings and conduct
Location: Guilan university of medical sciences, Al-Zahra hospital, gynecology clinic. 160 eligible patients will be included in this study.
participants were divided into two categories,Whether or not menopause and the randomization type is "Stratified Blocked Randomization ."In each category, eligible individuals during random allocation By blocked randomization will be allocated to the two groups receiving EPO and placebo.
the study was double-blind so that patients and outcome evaluation specialist are unaware of the allocation status of the two groups to the study.
Participants/Inclusion and exclusion criteria
Inclusion criterias: women candidates for hysteroscopy
Exclusion criterias: people who need laparoscopy , no pregnancy, absence of systemic diseases, cervical and vaginal infection, patients with bleeding disorders, consumers of anticoagulants, schizophrenia who use phenothiazine , epilepsy, and blood pressure, anomalies and cervical insufficiency, Mullerian abnormalities and history of cervical biopsy, prohibition of prostaglandins and cesarean delivery.
Intervention groups
Intervention group: group A, 1000 mg EPO in soft gel capsule will receive posterior vaginal fornix 6 hours before hysteroscopy.
Control group: group B will receive placebo in the same way as group A.
Main outcome variables
Factors examined include: interval of first resistance,duration of dilatation up to number10 hegar, duration of hysteroscopy, first hegar size ,ease of dilatation and need for mechanical dilatation as primary outcomes and cervical and uterine complications,side effects related to the drug used,pre-operative pain caused by drug use will be considered as secondary consequences.
General information
Reason for update
Enter a no entry criterion
Acronym
IRCT registration information
IRCT registration number:IRCT20080910001233N5
Registration date:2019-08-29, 1398/06/07
Registration timing:registered_while_recruiting
Last update:2021-08-07, 1400/05/16
Update count:1
Registration date
2019-08-29, 1398/06/07
Registrant information
Name
Maryam Asgharnia
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
asgharnia@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-06, 1398/05/15
Expected recruitment end date
2020-03-05, 1398/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Efficiency of Evening Primrose Oil on Cervical Ripening in Candidates for Operative Hysteroscopy: A Clinical Trial
Public title
Efficiency of Evening Primrose Oil on Operative Hysteroscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women candidates for hysteroscopy
Exclusion criteria:
People who need laparoscopy
Pregnant women
Existence of systemic diseases
infection of cervix
Existence of cervical anomalies
Existence of Mullerian anomalies
Contraindication prostaglandins.
patients with bleeding disorders
consumers of anticoagulants
patients with schizophrenia who use phenothiazine
patients With epilepsy
patients With blood pressure
People who need abdominal hysterectomy
infection of vaginal
Existence of cervical insufficiency
Existence of history of cervical biopsy
cesarean delivery
History of allergies to evening primros
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
first, participants were divided into two categories,Whether or not menopause and the randomization type is "Stratified Blocked Randomization ".
In each category, eligible individuals during random allocation
By blocked randomization will be allocated to the two groups receiving EPO and placebo.
The online site https://www.sealedenvelope.com will be used to generate a randomization list of study groups.Base on considering four blocks will be produced for 160 patients on site.
Blinding (investigator's opinion)
Double blinded
Blinding description
After generating the list, each person is assigned a unique code. None of the participants in the study will be aware of the randomization list , the groups are placed in closed envelopes in the admission section and eligible individuals who enter the study are included respectively.Therefore, the study was double-blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Research vice-chancellorship Building, in front of 17-Shahrivar Hospital, Shahid Siadati St., Namjoo Ave., Rasht, Guilan, IRAN
City
Rasht
Province
Guilan
Postal code
41446-66949
Approval date
2019-07-17, 1398/04/26
Ethics committee reference number
IR.GUMS.REC.1398.193
Health conditions studied
1
Description of health condition studied
Hysteroscopy surgical facilitation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
First resistance interval
Timepoint
Interval of first resistance based on duration to size of hegar dilator rejected without cervical resistance
Method of measurement
second
2
Description
Duration of dilatation to reach Hegar size 10
Timepoint
Interval from start of hysteroscopy hegar to create dilatation
Method of measurement
second
3
Description
Duration of hysteroscopy operation
Timepoint
Interval from the time of importing bogey to finishing importing bogey
Method of measurement
Minute
4
Description
First hegar size
Timepoint
During hysteroscopy
Method of measurement
Based on maximum dilator size (hegar),Which can be passed internal os without resistance.
5
Description
Ease of dilatation
Timepoint
During hysteroscopy
Method of measurement
Base on a 5-point Likert scale (excellent, good, average, poor, very poor)
6
Description
Requires mechanical dilatation
Timepoint
During hysteroscopy
Method of measurement
Based on clinical examination
Secondary outcomes
1
Description
Uterine and cervicovaginal complications (bleeding, uterine rupture, cervical rupture,false way ) during surgery
Timepoint
during surgery
Method of measurement
See any of the unusual complications: bleeding , uterine rupture, cervical rupture,false way
2
Description
Side effects related to the drug used
Timepoint
ِDuring operation up to 24 hours after surgery
Method of measurement
Occurrence of any of the following undesirable effects: allergic reactions, abdominal pain, nausea, diarrhea, headache, increased bowel movements
3
Description
Preoperative pain from medication
Timepoint
Immediately before surgery
Method of measurement
Scoring for pain by the patient using VSA (Zero = no pain) and (ten = unbearable pain)
Intervention groups
1
Description
Intervention group: group A, 1000 mg EPO in soft gel capsule(two in each, 500 mg) will receive posterior vaginal fornix 6 hours before hysteroscopy.
Category
Treatment - Drugs
2
Description
Control group: group B will receive placebo (in the same size and shape) in the same way as group A.