NCT06141447招募中2 期
Changes in Rate of Hemorrhage With Prophylactic Oxytocin for Second Trimester Dilation and Evacuation in the Clinic Setting
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Hemorrhage
研究概览
简要总结
The purpose of this study is to assess the effectiveness of prophylactic oxytocin on hemorrhage rates for second trimester dilation and evacuation (D&E) in the clinic setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
This will be a double blinded study.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •clinic-based D&E at 18 weeks gestational age and above
- •speaks English or Spanish
排除标准
- •refuses IV
- •history of coagulopathy
- •anticoagulant use in the preceding five days
- •chorioamnionitis or sepsis
- •suspected placenta accreta spectrum
- •intrauterine fetal demise
- •multiple gestation
- •use of misoprostol for cervical preparation
研究组 & 干预措施
Oxytocin
Experimental
Participants receive 40 units IV oxytocin in 1000 mL of normal saline at the time of tenaculum placement for D&E.
干预措施: Oxytocin + normal saline (Drug)
Placebo
Placebo Comparator
Participants receive 1000 mL of normal saline alone at the time of tenaculum placement for D&E.
干预措施: Normal saline (Drug)
结局指标
主要结局
Hemorrhage
时间窗: day of procedure
Quantitative blood loss greater than or equal to 500 mL or a clinical response to excessive bleeding such as transfusion or hospital admission
Quantitative blood loss
时间窗: day of procedure
Measured blood loss during procedure
次要结局
- Procedure time(day of procedure)
研究者
研究点 (1)
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