A Randomized Double-blinded Controlled Trial Comparing Dilation and Evacuation Outcomes With and Without Oxytocin Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Rate at Which Providers Intervene to Control Blood Loss During D&E Procedures.
研究概览
简要总结
Currently, there is very little research to identify ways to decrease blood loss during D&E (dilation and evacuation) procedures. The objective is to determine whether routine use of intravenous oxytocin will improve bleeding outcomes at the time of D&E at 18-24-weeks gestation. To evaluate the hypothesis, investigators will perform a randomized, double-blinded, placebo-controlled trial. The patient will be followed until discharged from the postoperative care unit during which time patient satisfaction, pain score and postoperative bleeding will be assessed.
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
- 14 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Requesting pregnancy termination
- •Intrauterine pregnancy at 18- to 24-weeks gestation
- •Gestational-age to be confirmed by ultrasound
- •Patients with fetal anomaly or intrauterine fetal demise that occurred at 18- to 24-weeks gestation
- •Willing and able to understand and sign written informed consents in English or Spanish and comply with study procedures
排除标准
- •Ultrasound findings suggestive of placenta accreta
- •Patients requiring preoperative misoprostol
研究组 & 干预措施
Placebo
500ml saline or lactated ringer without oxytocin added
干预措施: Intravenous Fluids and Electrolytes (Drug)
Treatment group
Intravenous oxytocin mixed with saline or lactated ringer
干预措施: intravenous oxytocin (Drug)
结局指标
主要结局
Rate at Which Providers Intervene to Control Blood Loss During D&E Procedures.
时间窗: During surgical procedure
次要结局
未报告次要终点
研究者
Bliss Kaneshiro
Professor of Obstetrics & Gynecology
University of Hawaii