Intracervical Vasopressin for Completion of Hysteroscopic Removal of Retained Products of Conception
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Completion of procedure hysteroscopically
研究概览
简要总结
This randomized study looks at whether using a medicine injected into the cervix of the uterus (intracervical), called vasopressin, helps to achieve better removal of retained products of conception (RPOC). RPOC means that after a pregnancy has ended (through miscarriage, abortion, or delivery), some parts of the pregnancy tissue, usually from the placenta or fetus, have stayed in the uterus. A hysteroscopic removal of RPOC is one type of treatment. This is a surgical procedure where a doctor uses a small camera attached to a thin tube (called a hysteroscope) to look inside the uterus.
The main goal of the study is :
• To add to the existing research through this study to see if the injection of intracervical vasopressin leads to improved completion rates of hysteroscopic management of RPOC.
Participants will:
• would be randomized to receive either vasopressin intracervical injection or a placebo injection (non-active saline) during your procedure. Information from the procedure will be collected from the participant's medical record.
详细描述
This double-blinded randomized control trial is designed to evaluate if intraoperative injection of intracervical vasopressin into the cervix will allow for completion of hysteroscopic removal of retained products of conception. This will be measured by surgical completion comparing patients who received intracervical vasopressin and those receiving placebo. Surgical completion is defined by completing the procedure without having to convert to suction of tissue due to bleeding or poor visualization. Secondary outcome measures include intraoperative bleeding, operative time, fluid deficit, and deficit volume.
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 51 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 18-51
- •Undergoing surgical management for retained products of conception, postpartum retained products of conception or 1st trimester missed or incomplete abortion
排除标准
- •Hemodynamic instability
- •Active hemorrhage- soaking pad/hour
- •Allergy to vasopressin
- •Concern for intrauterine arteriovenous malformation
- •Inability to consent
研究组 & 干预措施
Treatment
Vasopressin- 20 mL of a dilute solution (5 units of Vasopressin in 20cc injectable saline)
干预措施: Intracervical injection of Vasopressin (Drug)
Placebo
20 mL of saline
干预措施: Intracervical Injection of saline (Drug)
结局指标
主要结局
Completion of procedure hysteroscopically
时间窗: from start of procedure to end of procedure
There is complete removal of RPOC hysteroscopically by the end of the procedure.
次要结局
- Intraoperative Bleeding(from start of procedure to end of procedure)
- Operative time(time from insertion of hysteroscope to procedure completion)
- fluid deficit volume(from start of procedure to end of procedure)