Mifepristone Versus Misoprostol for Cervical Preparation Prior to Procedural Abortion at 12 to 16 Weeks' Gestation in an Academic Medical Center: a Randomized Controlled Pilot Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Percentage of participants achieving Intended dilation
研究概览
简要总结
The Investigator team hypothesizes that in a randomized trial comparing mifepristone-alone or misoprostol-alone for cervical preparation for procedural abortions at 12 to 16 weeks in hospital-based care, the proportion of patients who achieve successful cervical dilation will be different between the study groups.
详细描述
Cervical preparation is a critical component for the provision of safe abortion care in the later first trimester and beyond. The risk of surgical complications increases at 12 to 13 weeks gestation and routine use of cervical preparation is recommended. Cervical preparation options include misoprostol, mifepristone, and cervical dilators. Regimen choice is often guided by provider comfort, preference, or institutional guidelines. Misoprostol offers the advantage of facilitating same-day procedures, but side effects like pain and gastrointestinal symptoms can negatively affect patients' experiences. Furthermore, using misoprostol can pose logistical challenges in hospital-based main operating room environments, where abortions occur concurrently with all other surgical cases. Mifepristone is better tolerated than misoprostol but requires a multiple-day protocol for administration, which can pose logistical challenges.
Several studies demonstrate mifepristone's efficacy and safety as a cervical ripening agent for up to 16 weeks' gestation, however, despite its effectiveness, mifepristone for cervical preparation before procedural abortion has previously been limited by availability and cost. Recent studies demonstrating mifepristone's adjunctive benefit with osmotic dilators later in pregnancy, however, have broadened its use.
While most abortion care in the United States occurs in outpatient settings, about 3% occur in hospitals. This is expected to increase as the Dobbs versus Jackson Women's Health Organization decision exacerbates disparities in abortion access. In hospital-based abortion care, particularly at academic centers providing abortion training, there is a pressing need for innovative measures for cervical ripening. The Complex Family Planning Fellowship-trained faculty members at Montefiore will serve as research study surgeons. Cases will be performed in the main operating room under sedation or general anesthesia as determined by the anesthesiologist. A paracervical block of 20cc 1% lidocaine, with or without vasopressin, will be administered in accordance with standard practices.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •English or Spanish-speaking
- •Capacity to consent
- •Seeking induced abortion of a singleton pregnancy between 12 weeks, 0 days and 16 weeks, 6 days (based on age at day of surgery)
排除标准
- •History of more than two prior Cesarean deliveries
- •Sonographic evidence of placenta previa
- •Sonographic concern for morbidly adherent placenta
- •Prior obstetric hemorrhage requiring transfusion
- •Obstructive cervical or lower uterine segment fibroid
- •Current therapeutic anticoagulation use
- •Cerclage in situ
- •History of more than one prior cervical excisional procedure
- •BMI greater than 50 kg/m^2
研究组 & 干预措施
Mifepristone
Patients will be randomized to Mifepristone-alone in a 1:1 manner prior to procedural abortions. A paracervical block of 20 cubic centimeters (cc) 1% lidocaine, with or without vasopressin, will be administered in accordance with standard practices.
干预措施: Mifepristone (Drug)
Misoprostol
Patients will be randomized to Misoprostol-alone in a 1:1 ratio prior to procedural abortions. A paracervical block of 20cc 1% lidocaine, with or without vasopressin, will be administered in accordance with standard practices.
干预措施: Misoprostol (Drug)
结局指标
主要结局
Percentage of participants achieving Intended dilation
时间窗: At time of surgery
The proportion of participants achieving intended dilation at the start of the procedure will be summarized by treatment group and reported in percentages. Achievement of intended dilation will be determined by the attending surgeon. Overdilation resulting in passage of products of conception prior to time of surgery will be characterized as a treatment failure.
次要结局
- Estimated blood loss(Start to end of procedure, up to 4 hours)
- Presence of Intraoperative Complications(From preoperative visit to discharge, up to 2 days)
- Surgical time(Start to end of procedure, up to 4 hours)
- Patient Satisfaction(From preoperative visit to discharge, up to 2 days)
- Provider Satisfaction(From preoperative visit to discharge, up to 2 days)
- Cervical dilation at start of procedure(Start of the Procedure)