Different Routes of Misoprostol for Same-day Cervical Preparation Prior to First Trimester Surgical Abortion: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Preoperative cervical width in centimeters
研究概览
简要总结
A randomized clinical trial to assess the effectiveness of same-day cervical preparation with oral, buccal or vaginal Misoprostol, given 2-4 hours prior first trimester curettage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients admitted for elective first trimester abortion (termination of pregnancy/ missed abortion) at Wolfson Medical Center, gestational age <13+0 weeks
- •Written consent supplied
排除标准
- •Contraindications to prostaglandin treatment (severe asthma, glaucoma, severe cardiac disease, renal failure)
- •Prostaglandin allergy
- •Genital infection
- •Space-occupying lesion in the endocervical canal
- •Prior cervical surgery
研究组 & 干预措施
PO Misoprostol
Cervical preparation with per-os (PO) Misoprostol 400 mcg 2-4 hours prior to curettage
干预措施: Misoprostol (cytotec) (Drug)
PV Misoprostol
Cervical preparation with per-vagina (PV) Misoprostol 400 mcg 2-4 hours prior to curettage
干预措施: Misoprostol (cytotec) (Drug)
Buccal Misoprostol
Cervical preparation with buccal Misoprostol 400 mcg 2-4 hours prior to curettage
干预措施: Misoprostol (cytotec) (Drug)
结局指标
主要结局
Preoperative cervical width in centimeters
时间窗: intraoperative
• Initial cervical dilatation assessed by performing cervical dilatation , beginning with a number 10 Hegar dilator and subsequently inserting smaller Hegar dilators until the dilator can pass through the internal os without resistance. The largest one to pass will consist the initial cervical width.
次要结局
- Patient preference(baseline)
- Adverse effects of medication(baseline)
- Time required to achieve cervical dilatation(intraoperative)
- Ease of cervical dilatation(intraoperative)
- Surgical complications(intraoperative)
研究者
Hadas Ganer Herman
MD
Wolfson Medical Center