Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Length of Procedure
研究概览
简要总结
In this study the investigators plan to compare mifepristone and misoprostol use to osmotic dilator use for cervical preparation for 15-18 week surgical abortion. Mifepristone would be given 24 hours prior to abortion, and misoprostol 400 mcg would be administered buccally 2 hours prior to abortion. Osmotic dilators are the method currently used in our institution, and are placed 24 hours prior to abortion. The primary outcome will be the length of the procedure. Secondary outcomes will include amount of dilation achieved, ease of procedure, participant's assessment of discomfort before mifepristone or dilators, discomfort during the abortion procedure, acceptability to participants, and acceptability to staff.
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
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18-50 years of age undergoing surgical termination of pregnancy
- •English or Spanish speaking
- •Gestational age between 15 and 18 weeks gestation on day of abortion (inclusive), by ultrasound dating
- •Eligible for a dilation and evacuation abortion with local anesthesia and sedation
- •Ultrasound for dating purposes done within the last two weeks
排除标准
- •Intrauterine infection
- •Fetal demise
- •Ruptured membranes
- •Multiple gestation
- •Uterine anomaly or significant distortion of the uterus with fibroids
- •BMI greater than 45
- •Inability to place osmotic dilators
- •Active substance abuse or intoxication
- •Adrenal failure, chronic corticosteroid use, anticoagulant usage
- •Severe cervicitis, until treated and resolved
- •Prior Cesarean section
研究组 & 干预措施
Osmotic dilators
Placed 20-24 hours prior to procedure
干预措施: osmotic dilators (Device)
Mifepristone + misoprostol
Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure
干预措施: Mifepristone (Drug)
结局指标
主要结局
Length of Procedure
时间窗: Subjects will be followed from the administration of mifepristone/misoprostol or laminaria, until the end of their procedure, a total of two days.
Interval from speculum insertion to speculum removal
次要结局
- Subject Discomfort Before the Abortion(Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.)
- Pain Medication (Fentanyl) During the Abortion(Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.)
- Operative Time(Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.)
- Cervical Dilation Achieved(At time of abortion)
- Acceptability to Patient(After procedure completion)
- Difficulty of Procedure(After completion of procedure)
- Pain Medication (Midazolam) During the Abortion(Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.)