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IRCT20211013052756N1 IRCT 2021-11-05 Iran University of Medical Sciences Comparison of vaginal estradiol in cervical ripening with misoprostol Comparison of vaginal misoprostol with and without vaginal estrogen in cervical ripening before operative hysteroscopy in postmenopausal women 2019-12-22 anticipated 102 Complete https://irct.ir/trial/59550 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Restricted randomization with the permuted block method was used to create the random sequence and balance the number of allocated samples in intervention group (Vaginal misoprostol + estrogen, N=51) and control group (Vaginal misoprostol, N=51). The computer program was used for a random sequence using Excel, Rand function, in blocks of 2, 4, and 6. Each block has an equal number of control and HemoHIM groups. It is written on the cards and placed respectively for hiding in locked opaque packets. A packet was selected for each patient according to the study recruitment, which determines the related study group, Blinding description: The patient is unaware of the allocation of drugs because he/she will be anesthetized and the statistical analyzer will receive the groups in the form of codes A and B and is unaware of the type of intervention in the groups. 3 Menopause. Intervention 1: Intervention group: Patients in the intervention group were treated with one third of 4 gr applicator of vaginal cream 0.625mg estrogen conjugate (each 1gr contains 0.625 mg conjugated estrogen produced by Aburaihan pharmaceutical Co) for 5 days the week before surgery as daily consumption at home. Also, this group received 200 micrograms of vaginal misoprostol tablets (Sami Saz Pharmaceutical Co) 6 hours before surgery. Intervention 2: Control group: This group received only 200 micrograms of vaginal misoprostol tablets (Sami Saz Pharmaceutical Co) 6 hours before surgery. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mahsa Kiani
No 8, Amani street, Shariati street , Tehran, Iran
Tehran Iran (Islamic Republic of) 1948643451 +98 21 2286 4111 dr.m.kiani87@gmail.com Iran University of Medical Sciences scientific Mahsa Kiani
No 8, Amani street, Shariati street, Tehran, Iran.
Tehran Iran (Islamic Republic of) ۱۹۴۸۶۴۳۴۵۱ +98 21 2286 4111 dr.m.kiani87@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Postmenopausal women (at least more than 1 year after the last menstrual cycle) Candidates for hysteroscopy Patients must have a normal mammogram and Pap smear within the last 2 years no limit no limit Female Recent or current pelvic infection History of cervical conization Previous surgery on the cervix hypersensitivity to prostaglandins History of venous thrombosis Cardiovascular disease Cervical or breast malignancies Mullerian anomaly Cervical anomalies N95 Menopausal and other perimenopausal disorders Treatment - Drugs Treatment - Drugs Intervention group: Patients in the intervention group were treated with one third of 4 gr applicator of vaginal cream 0.625mg estrogen conjugate (each 1gr contains 0.625 mg conjugated estrogen produced by Aburaihan pharmaceutical Co) for 5 days the week before surgery as daily consumption at home. Also, this group received 200 micrograms of vaginal misoprostol tablets (Sami Saz Pharmaceutical Co) 6 hours before surgery. Control group: This group received only 200 micrograms of vaginal misoprostol tablets (Sami Saz Pharmaceutical Co) 6 hours before surgery. Hegar cervical dilator during hysteroscopy. Timepoint: One during hysteroscopy. Method of measurement: Observation. Cervical softness and stenosis. Timepoint: One during hysteroscopy. Method of measurement: Observation. Pain. Timepoint: One 6 hours after hysteroscopy. Method of measurement: Visual analogue scale. Iran University of Medical Sciences Approved 2019-11-26 Ethics committee of Iran University of Medical Sciences No8,amani street, shariati street, tehran,iran. Tehran Tehran Iran (Islamic Republic of)