]>
IRCT201012272576N3 IRCT 2011-04-06 Vice chancellor for research., Tehran university of medical science Randomized double blind placebo-controlled clinical trial comparison vaginal with sublingual misoprostol in preoperative ripening of the cervix before operative -diagnostic hysteroscopy in premenopausal women in Mirzakuchak-khan hospital at 2010-2011 Randomized double blind placebo-controlled clinical trail comparison vaginal with sublingual misoprostol in preoperative ripening of the cervix before operative -diagnostic hystroscopy in premenopausal women in mirzakuchak-khan hospital at 2010-2011 2010-05-22 anticipated 100 Complete https://irct.ir/trial/2329 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2-3 Hysteroscopy. Intervention 1: 100 patients were randomly assigned to the following treatment regiment . The vaginal group recieved 400micg of misoprostol one time six hours before hysteroscopy (placed into the posterior vaginal fornix) and at the same time recieved one tablet of vit B6 sublingualy as placebo. . Intervention 2: The sublingual group received 400micg of misoprstol sublingually one time six hours before hysteroscopy and at the same time received one tablet of vitB6 as placebo. AbstractSend to:<br /> Arch Gynecol Obstet. 2013 May;287(5):937-40. doi: 10.1007/s00404-012-2652-4. Epub 2012 Dec 4.<br /> Sublingual versus vaginal misoprostol for cervical ripening before hysteroscopy: a randomized clinical trial.<br /> Tanha FD1, Salimi S, Ghajarzadeh M.<br /> Author information<br /> Abstract<br /> PURPOSE:<br /> To evaluate the efficacy of two routes of misoprostol (sublingual and vaginal) for cervical ripening before hysteroscopy.<br /> METHODS:<br /> One hundred and ten perimenopausal women who were referred to a tertiary hospital for surgical hysteroscopy enrolled in this double-blind randomized clinical trial. They were divided into two groups to receive 400 mg misoprostol either sublingually or vaginally 6 h before hysteroscopy. The duration of dilatation, Hegar number inserted into the cervix without resistance, and hysteroscopic and drug complications were recorded for all cases.<br /> RESULTS:<br /> Forty-nine women in sublingual and 51 in vaginal group participated in the study. Dilatation time was significantly lower in sublingual group (P < 0.001). Median Hegar number passed into the cervix without resistance was 5 in sublingual versus 4 in vaginal group (P = 0.002). Cramp followed by vomiting and diarrhea were the most common side effects of misoprostol in the sublingual group, while cramp followed by vomiting was the most frequent side effect in the vaginal group. Diarrhea was not reported in the vaginal group (P = 0.008).<br /> CONCLUSION:<br /> Sublingual route of misoprostol could be considered as an effective medication before surgical hysteroscopy in perimenopausal women.
public Fateme Davari Tanha
Mirza Kuchak Khan Hospital, Ostad Nejatolahi Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 15978 +98 21 8889 7761 fatedavari@yahoo.com Tehran University ofMedical Sciences scientific Fateme Davari Tanha
Mirza Kuchak Khan Hospital, Ostad Nejatolahi Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 15978 +98 912 193 1231 fatedavari@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) The inclusion criteria: woman who gave consent for operative-diagnostic hysteroscopy; and were of reproductive age (i.e.; were premenopausal) ; and not pregnant at the time of presentation." The exclusion criteria: contraindication to PGs (history of severe asthma; glaucoma; preexisting cardiac disease; hypertension, or renal failure); significant uterovaginal prolapsed precluding the administration of vaginal tablets; or history of cervical surgery or cervical incompetency; women who had sub mucosal fibroma larger than 2cm (because of partial dilatation of cervix). 14 years 50 years Female N88.9 Non inflammatory disorder of cervix uteri, unspecified Treatment - Drugs Treatment - Drugs 100 patients were randomly assigned to the following treatment regiment . The vaginal group recieved 400micg of misoprostol one time six hours before hysteroscopy (placed into the posterior vaginal fornix) and at the same time recieved one tablet of vit B6 sublingualy as placebo. . The sublingual group received 400micg of misoprstol sublingually one time six hours before hysteroscopy and at the same time received one tablet of vitB6 as placebo Duration of cervical dilatation time in with 9 hegar could be inserted after prescription of sublingual or vaginal misoprostol. Timepoint: 6houres after prescription of sublingual or vaginal misoprostol. Method of measurement: The largest hegar that could be passed without resistance was starting time of dilatation. Complications of hysteroscopy. Timepoint: 6hours after misoprostol prescription. Method of measurement: clinical. Vice chancellor for research., Tehran university of medical science Approved 2010-06-20 Ethics committee of Tehran University of Medical Sciences Keshavarz Blvd, Ghods Ave, Tehran University of Medical Sciences Tehran Iran (Islamic Republic of)