Cervical Preparation With Mifepristone Prior to Osmotic Dilators: A Randomized, Double-blind, Placebo-controlled Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Number of Participants That Had Placement of Expected Dilators or More
研究概览
简要总结
The investigators plan to study the role of mifepristone prior to the placement of cervical osmotic dilators to evaluate if the medication helps increase the number of dilators. This may help improve safety of dilation and evacuation (D&E) procedures.
详细描述
No clear guideline currently exists for best practices involving cervical preparation for women planning dilation and evacuation at 20 weeks and greater. The investigators plan to perform a pilot, randomized, double-blind, placebo-controlled trial. On day 1, 66 participants will receive mifepristone 200 mg orally or placebo 18-24 hours prior to osmotic dilator (Dilapan-S 4-mm) placement (day 2). On day 3, participants will have a D&E procedure. Enrollees will be 18 weeks 0 days to 23 weeks 6 days gestation on the day of the procedure. The primary objective is to evaluate the role of adjunctive mifepristone the day prior to osmotic dilator placement for dilation and evacuation procedures. The primary outcome will be the number of dilators successfully placed. Investigators will compare the number of dilators placed between study arms stratified by gestational age. Secondary outcomes include cervical dilation at time of procedure, proportion of women requiring mechanical dilation at time of surgery, provider impression on ease of procedure and/or difficulty in dilating the cervix when clinically required, and overall complications. Complications or adverse events include cervical laceration requiring repair, perforations, blood transfusions, ED visits, hospitalizations, infection, additional surgical procedures, or extramural deliveries.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •A. Age ≥18 years B. Gestational age to be 18 weeks 0 days through 23 weeks 6 days on procedure date C. Signed informed procedure consent for dilation and evacuation D. Willing to sign informed consent and follow study protocol
排除标准
- •A. Allergy or known intolerance to mifepristone
- •B. Known contraindication to mifepristone for cervical preparation prior to dilation and evacuation:
- •Chronic adrenal failure or insufficiency
- •Concurrent use of long-term corticosteroid therapy
- •Inherited porphyrias
- •C. Any condition that in the opinion of the investigator could impede study participation or collection of study data
研究组 & 干预措施
Mifepristone
Participants ingest mifepristone 200 mg oral medication once 18-24 hours prior to dilator placement
干预措施: Mifepristone 200 MG (Drug)
Placebo
Participants ingest placebo oral medication once 18-24 hours prior to dilator placement
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Number of Participants That Had Placement of Expected Dilators or More
时间窗: At time of 1 hour clinic visit (10 minutes)
The number of expected dilators (Dilapan-S) is calculated based on the gestational age. Four dilators are expected to be placed at 18 weeks 0 days to 19 weeks 6 days gestation. Five dilators are expected to be placed at 20 weeks 0 days to 20 weeks 6 days gestation. Six dilators are expected to be placed at 21 weeks 0 days to 21 weeks 6 days gestation. Seven dilators are expected to be placed at 22 weeks 0 days to 23 weeks 5 days gestation. Therefore, at any given gestational age, if the expected number of dilators (or additional dilators) were placed, the participant was counted as "Yes, participant had placement of expected dilators or more."
次要结局
- Cervical Dilation(At time of ~1 hour scheduled procedure time (1 minute))
- Number of Participants That Required Mechanical Dilation(At time of ~1 hour scheduled procedure time)
- Pain Dilator Placement Using Visual Analog Scale(At time of 1 hour clinic visit (10 minutes))
- Provider Assessment of Procedure as "Very Easy" or "Easy"(At time of ~1 hour scheduled procedure time)
- Number of Participants That Experienced Complications(At time of ~1 hour scheduled procedure time (0-30 minute))