Mifepristone Versus Osmotic Dilators in Conjunction With Misoprostol for Cervical Preparation Prior to D&E at 14-19 Weeks
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Procedure Time
研究概览
简要总结
Dilation and evacuation (D&E) is a common surgical procedure in the U.S. Adequate pre-operative preparation of the uterine cervix is an important part of preventing complications of the procedure. Traditionally, the uterine cervix is prepared for the procedure using water-attracting dilators, which are placed via a speculum exam and cause discomfort for many women. The objective of this study is to investigate the comparative effectiveness of mifepristone (an oral tablet) versus dilators for cervical preparation for D&E.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •>18 Years Old
- •Viable, Singleton pregnancy
- •Voluntarily seeking abortion between 14-19 weeks gestation
- •Able to give informed consent and comply with study protocol
- •Fluent in English or Spanish
排除标准
- •Allergy to study drugs
研究组 & 干预措施
Dilapan (14wks 0days-15wks, 6days)
The clinician will place 1 to 2 osmotic cervical dilators (Dilapan-S) (4mm x 65mm) the day before the participant's procedure.
干预措施: Hygroscopic cervical dilators (Device)
Dilapan (16wks 0days-18wks, 6days)
The clinician will place 3 to 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure.
干预措施: Misoprostol (Drug)
Dilapan (16wks 0days-18wks, 6days)
The clinician will place 3 to 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure.
干预措施: Hygroscopic cervical dilators (Device)
Mifepristone (14wks 0days-15wks, 6days)
The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure.
干预措施: Misoprostol (Drug)
Mifepristone (14wks 0days-15wks, 6days)
The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure.
干预措施: Mifepristone (Drug)
Mifepristone (16wks 0days-18wks, 6days)
The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure.
干预措施: Misoprostol (Drug)
Mifepristone (16wks 0days-18wks, 6days)
The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure.
干预措施: Mifepristone (Drug)
结局指标
主要结局
Procedure Time
时间窗: Intraoperative
Measured as time from speculum insertion to removal.
次要结局
- Cervical Dilation(Baseline)
- Total Procedure Time(Measured at clinic visit and on OR day, over 2 day period)
- Difficulty of Procedure, as reported by clinician(Measured within 5 minutes after procedure)
- Complications/Adverse Events(Intraoperatively)
- Pain Perceived by Patient(Intraoperatively "Measured during dilator placement")
- Overall Patient Experience(Measured post-operatively (30 minutes prior to discharge))