Buccal Versus Vaginal Misoprostol for Cervical Ripening Prior to Surgical Termination of the First Trimester Missed Abortion in Erbil
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare the efficacy of buccal administration to the more commonly vaginal route for preoperative cervical and priming in patients with first trimester surgical abortion. (Buccal Vs. Vaginal Misoprostol in the First Trimester Missed Abortion.)
研究概览
简要总结
The purpose of this study is to determine the effectiveness of buccal misoprostol and comparing this with vaginal route of the same drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •first trimester missed abortion
排除标准
- •history or evidence of disorders that represent contraindication to the use of misoprostol:
- •severe pulmonary diseases
- •congenital or acquired heart diseases
- •prolonged use of corticosteroid
- •sickle cell anemia and adrenal insufficiency
- •known hypersensitivity to drugs
- •any evidence of infection
- •patient's refusal to participate in the study
- •patients with abnormal results of investigations
- •patients with previous operations on cervix like conisation, cauterization, previous dilatation and curettage
- •patients with complete abortion
- •patients with severe bleeding that required emergency surgical evacuation of the uterus
- •patients with partially dissolved tablets at the site of application in both groups
研究组 & 干预措施
Buccal Misoprostol
Group one: 50 patients with first trimester missed abortion received buccal misoprostol
干预措施: Misoprostol (given buccally) (Drug)
Vaginal Misoprostol
Group two: 5 patients received vaginal misoprostol
干预措施: Misoprostol (given vaginally) (Drug)
Buccal and Vaginal Misoprostol
50 primiparous and 50 multiparous women: one hundred patients have been administered the medication buccally (25 primigravida and 25 multigravida), and vaginally (25 primigravida and 25 multigravida), three hours before dilation and curettage. They were admitted to the hospital one day before the surgical evacuation, and preparation of cross matched blood done for all recruited subjects.
Each group was randomly allocated (1,3,5,... for the buccal group & 2,4,6,... for the vaginal group) to receive 400 microgram misoprostol.
干预措施: Misoprostol (given buccally) (Drug)
Buccal and Vaginal Misoprostol
50 primiparous and 50 multiparous women: one hundred patients have been administered the medication buccally (25 primigravida and 25 multigravida), and vaginally (25 primigravida and 25 multigravida), three hours before dilation and curettage. They were admitted to the hospital one day before the surgical evacuation, and preparation of cross matched blood done for all recruited subjects.
Each group was randomly allocated (1,3,5,... for the buccal group & 2,4,6,... for the vaginal group) to receive 400 microgram misoprostol.
干预措施: Misoprostol (given vaginally) (Drug)
结局指标
主要结局
To compare the efficacy of buccal administration to the more commonly vaginal route for preoperative cervical and priming in patients with first trimester surgical abortion. (Buccal Vs. Vaginal Misoprostol in the First Trimester Missed Abortion.)
时间窗: March 2007 to March 2008
次要结局
- The secondary objectives are to compare the side effects and acceptability by the subjects.(March 2007 to March 2008)