Protocol summary
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Study aim
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Determining the efficiency of evening Primrose Oil on operative hysteroscopy
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Design
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Clinical trial with control group, with parallel groups, double blind, randomized
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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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
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Reason for update
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Enter a no entry criterion
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Acronym
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IRCT registration information
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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
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Registration date
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2019-08-29, 1398/06/07
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-08-06, 1398/05/15
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Expected recruitment end date
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2020-03-05, 1398/12/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of the Efficiency of Evening Primrose Oil on Cervical Ripening in Candidates for Operative Hysteroscopy: A Clinical Trial
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Public title
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Efficiency of Evening Primrose Oil on Operative Hysteroscopy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
160
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-07-17, 1398/04/26
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Ethics committee reference number
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IR.GUMS.REC.1398.193
Health conditions studied
1
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Description of health condition studied
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Hysteroscopy surgical facilitation
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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First resistance interval
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Timepoint
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Interval of first resistance based on duration to size of hegar dilator rejected without cervical resistance
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Method of measurement
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second
2
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Description
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Duration of dilatation to reach Hegar size 10
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Timepoint
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Interval from start of hysteroscopy hegar to create dilatation
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Method of measurement
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second
3
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Description
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Duration of hysteroscopy operation
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Timepoint
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Interval from the time of importing bogey to finishing importing bogey
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Method of measurement
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Minute
4
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Description
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First hegar size
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Timepoint
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During hysteroscopy
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Method of measurement
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Based on maximum dilator size (hegar),Which can be passed internal os without resistance.
5
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Description
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Ease of dilatation
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Timepoint
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During hysteroscopy
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Method of measurement
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Base on a 5-point Likert scale (excellent, good, average, poor, very poor)
6
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Description
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Requires mechanical dilatation
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Timepoint
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During hysteroscopy
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Method of measurement
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Based on clinical examination
Secondary outcomes
1
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Description
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Uterine and cervicovaginal complications (bleeding, uterine rupture, cervical rupture,false way ) during surgery
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Timepoint
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during surgery
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Method of measurement
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See any of the unusual complications: bleeding , uterine rupture, cervical rupture,false way
2
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Description
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Side effects related to the drug used
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Timepoint
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ِDuring operation up to 24 hours after surgery
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Method of measurement
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Occurrence of any of the following undesirable effects: allergic reactions, abdominal pain, nausea, diarrhea, headache, increased bowel movements
3
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Description
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Preoperative pain from medication
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Timepoint
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Immediately before surgery
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Method of measurement
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Scoring for pain by the patient using VSA (Zero = no pain) and (ten = unbearable pain)
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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Control group: group B will receive placebo (in the same size and shape) in the same way as group A.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Rasht University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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There are no plans to share and publish it, yet
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When the data will become available and for how long
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The beginning of the access period is 6 months after the publication of the study results.
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To whom data/document is available
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All interested in study.
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Under which criteria data/document could be used
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No plans have been made for it yet.
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From where data/document is obtainable
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by Email
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What processes are involved for a request to access data/document
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Not yet planned for it.
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Comments
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