NCT06964373招募中不适用
Cervical Ripening Balloon for Same-Day Cervical Preparation for Second Trimester Termination
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- D&E procedure length (minutes)
研究概览
简要总结
The goal of this clinical trial is to learn if a cervical ripening balloon (Foley balloon) works to prepare the cervix before same-day outpatient dilation and evacuation (D&E). The main questions it aims to answer are:
- Is cervical preparation with cervical ripening balloon for same-day outpatient D&E non-inferior to cervical preparation with osmotic dilators?
- How feasible and safe is cervical preparation with cervical ripening balloon for same-day outpatient D&E?
- How acceptable is cervical preparation with cervical ripening balloon for same-day outpatient D&E?
Participants will:
- Have cervical preparation with cervical ripening balloon (experimental group) or osmotic dilators (usual care group)
- Complete two surveys, one about the cervical preparation and one about the D&E procedure
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Individuals who desire outpatient dilation and evacuation (D&E)
- •At least 18 years of age
- •Able and willing to consent
- •Gestational duration between 18 weeks 0 days and 19 weeks 6 days as determined by ultrasound
- •Able to read and understand English or Spanish
- •Able to obtain reliable post-procedure transportation
- •Able to observe fasting guidelines of 6 hours prior to the D&E procedure
排除标准
- •Medical conditions that require procedural management in the operating room
- •Preference for D&E procedure in the operating room
研究组 & 干预措施
Osmotic Dilators
Active Comparator
干预措施: Osmotic Dilators (Device)
Cervical Ripening Balloon
Experimental
干预措施: Cervical Ripening Balloon (Device)
结局指标
主要结局
D&E procedure length (minutes)
时间窗: during procedure
From insertion of first instrument to removal of speculum
次要结局
- Additional sedation medication administered(during procedure)
- Administration of uterotonic medications(during procedure)
- Cervical laceration(during procedure)
- Estimated blood loss > 500 milliliters(From enrollment to 24 hours after enrollment)
- Hospital transfer(From enrollment to 24 hours after enrollment)
- Starting dilation (French gauge)(during procedure)
- Additional dilation (French gauge)(during procedure)
- Estimated blood loss (milliliters)(during procedure)
- Pain (Visual Analog Scale)(during procedure)
- Feasibility of cervical preparation (physician-reported)(From enrollment to 24 hours after enrollment)
- Likelihood to recommend cervical preparation (participant-reported)(From enrollment to 24 hours after enrollment)
- Acceptability of cervical preparation (physician-reported)(From enrollment to 24 hours after enrollment)
- Satisfaction with level of pain management (participant-reported)(From enrollment to 24 hours after enrollment)
研究者
研究点 (1)
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