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IRCT20151228025732N68 IRCT 2021-05-25 Semnan University of Medical Sciences A comparative study of vaginal hyoscine butyl bromide and misoprostol on cervical ripening for gynecological intrauterine procedures A comparative study of vaginal hyoscine butyl bromide and misoprostol on cervical ripening for gynecological intrauterine procedures 2021-05-05 anticipated 50 Complete https://irct.ir/trial/55826 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are allocated randomly with simple sequential allocation in one of the two study groups by help of sealed envelope and receive the intervention of the same group. The unit of randomization is patient. Sealed envelopes are delivered to expert. With each patient's visit, one of the envelopes is randomly selected by the patients and determines the study group. The stratification approach is not used, Blinding description: Drug packaging is coded. So that the evaluators and patients are unaware of the drug content packaging and intervention that they receive. 3 Intrauterine interventions. Intervention 1: Intervention group: Hyoscine butylbromide oral tablet (40 mg dose) is inserted vaginally into the posterior cervical region 2 hours before the intervention. Intervention 2: Control group: Misoprostol (200µg) is inserted vaginally into the posterior cervical region 2 hours before the intervention. 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 more information.
public Shahrzad Aghaamoo
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
Semnan Iran (Islamic Republic of) 3514799442 +98 23 3345 1336 are20935@gmail.com Semnan University of Medical Sciences scientific Shahrzad Aghaamoo
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
Semnan Iran (Islamic Republic of) 3514799442 +98 23 3345 1336 are20935@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) Age 18 to 55 years Before menopause 18 years 55 years Female Pregnancy History of more than 3 deliveries Anatomic abnormalities in the genital tract Infection or wound visible in the cervix or vagina Z01.4 Encounter for gynecological examination Diagnosis Diagnosis Intervention group: Hyoscine butylbromide oral tablet (40 mg dose) is inserted vaginally into the posterior cervical region 2 hours before the intervention. Control group: Misoprostol (200µg) is inserted vaginally into the posterior cervical region 2 hours before the intervention. Cervical diameter. Timepoint: Before and after the intervention. Method of measurement: The largest size of Hegar dilator that can be inserted without resistance and easily. The amount of pain. Timepoint: Before and after the intervention. Method of measurement: Visual analogue scale for pain (0 to10). Bleeding rate. Timepoint: Before and after the intervention. Method of measurement: Cylindrical (cc). Semnan University of Medical Sciences Approved 2021-02-23 Ethics committee of Semnan University of Medical Sciences Semnan University of Medical Sciences, Basij Blvd, Semnan Semnan Semnan Iran (Islamic Republic of)