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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
AbstractSend to:
Arch Gynecol Obstet. 2013 May;287(5):937-40. doi: 10.1007/s00404-012-2652-4. Epub 2012 Dec 4.
Sublingual versus vaginal misoprostol for cervical ripening before hysteroscopy: a randomized clinical trial.
Tanha FD1, Salimi S, Ghajarzadeh M.
Author information
Abstract
PURPOSE:
To evaluate the efficacy of two routes of misoprostol (sublingual and vaginal) for cervical ripening before hysteroscopy.
METHODS:
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.
RESULTS:
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).
CONCLUSION:
Sublingual route of misoprostol could be considered as an effective medication before surgical hysteroscopy in perimenopausal women.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 14 years 至 50 years（—）
- 性别
- Female
入选标准
- •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).
排除标准
- 未提供