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IRCT20080910001233N5 IRCT 2019-08-29 Rasht University of Medical Sciences Efficiency of Evening Primrose Oil on Operative Hysteroscopy Evaluation of the Efficiency of Evening Primrose Oil on Cervical Ripening in Candidates for Operative Hysteroscopy: A Clinical Trial 2019-08-06 anticipated 160 Complete https://irct.ir/trial/41153 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Hysteroscopy surgical facilitation. Intervention 1: 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. Intervention 2: Control group: group B will receive placebo (in the same size and shape) in the same way as group A. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no planning to share and publish.
public Maryam Farrokhfar
Al-Zahra Hospital, Namjoo Ave., Rasht, Guilan, IRAN
Rasht Iran (Islamic Republic of) 54839- 41446 +98 13 3336 9224 sfarrokhfar@yahoo.com Rasht University of Medical Sciences scientific Dr. Maryam Asgharnia
Al-Zahra Hospital, Namjoo Ave., Rasht, Guilan, IRAN
Rasht Iran (Islamic Republic of) 54839 -41446 +98 13 3336 9224 asgharnia@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) Women candidates for hysteroscopy no limit no limit Female 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 Treatment - Drugs Treatment - Drugs 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. Control group: group B will receive placebo (in the same size and shape) in the same way as group A. First resistance interval. Timepoint: Interval of first resistance based on duration to size of hegar dilator rejected without cervical resistance. Method of measurement: second. Duration of dilatation to reach Hegar size 10. Timepoint: Interval from start of hysteroscopy hegar to create dilatation. Method of measurement: second. Duration of hysteroscopy operation. Timepoint: Interval from the time of importing bogey to finishing importing bogey. Method of measurement: Minute. First hegar size. Timepoint: During hysteroscopy. Method of measurement: Based on maximum dilator size (hegar),Which can be passed internal os without resistance. Ease of dilatation. Timepoint: During hysteroscopy. Method of measurement: Base on a 5-point Likert scale (excellent, good, average, poor, very poor). Requires mechanical dilatation. Timepoint: During hysteroscopy. Method of measurement: Based on clinical examination. 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. 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. 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). Rasht University of Medical Sciences Approved 2019-07-17 Ethics committee of Guilan University of Medical Sciences Research vice-chancellorship Building, in front of 17-Shahrivar Hospital, Shahid Siadati St., Namjoo Ave., Rasht, Guilan, IRAN Rasht Guilan Iran (Islamic Republic of)