Misoprostol Effect on Second Trimester Abortion Blood Loss
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Number of Participants With Hemorrhage Greater Than 500 mL as a Measure of Quantified Blood Loss
研究概览
简要总结
Although serious complications from second trimester abortion are rare hemorrhage is the most common cause of procedural abortion related morbidity and mortality. Misoprostol is a prostaglandin E1 analogue that is used by 75% of clinicians prior to procedural abortion for the purpose of cervical preparation. Misoprostol is also known to decrease blood loss in first trimester abortion and is used to treat postpartum hemorrhage, however the effect of preprocedural misoprostol on procedural blood loss is not well described.
We will conduct a double blinded placebo-controlled gestational age stratified superiority trial of those undergoing procedural abortion between 18 and 23 weeks gestation at Stanford Health care. Participants will be randomized to either 400mcg buccal misoprostol or placebo on the day of the procedure. A quantified blood loss (QBL) will be measured during the procedure and participants will complete a survey to assess symptoms. Our primary outcome is quantified blood loss. Secondary outcomes include clinical interventions to manage excess bleeding, total procedure time, provider reported experience, patient reported experience.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pregnant people, 18 years of age or older; intrauterine pregnancy between 18/0-23/6 weeks of gestational age (by ultrasound dating performed prior to same day of enrollment visit) consented for an induced abortion; English or Spanish speaking, able to consent for a research study, literate in English or Spanish.
排除标准
- •known coagulopathy, suspected morbidly adherent placenta spectrum, multiple gestation, current infection, ruptured membranes, or fetal demise at time of enrollment.
研究组 & 干预措施
Misoprostol 400mcg buccal
Participants will take 400mcg buccal misoprostol 2-3 hours prior to their procedure
干预措施: Misoprostol 400mcg buccal (Drug)
Placebo
Participants will take a placebo buccally 2-3 hours prior to their procedure
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Hemorrhage Greater Than 500 mL as a Measure of Quantified Blood Loss
时间窗: day of procedure (approximately 1 hour)
Quantified blood loss calculated using a combination of gravimetric and direct measurements of drapes, suction contents, and suction container.
次要结局
- Patient-reported Pain Scale Score(Day of procedure: before medication administration (2-3 hours prior to procedure); and after medication administration (up to 1 hour following completion of procedure))
- Overall Satisfaction With Care Experience Scale Score(after procedure (approximately 1 minute to complete survey))
- Number of Participants With Vaginal Bleeding(during procedure (up to 1 hour), after medication administration)
- Number of Participants Requiring Manual Dilation(during procedure (up to 1 hour))
- Physician-rated Satisfaction With Dilation Scale Score(after procedure (approximately 1 minute to complete survey))
- Number of Participants With Abdominal Pain(during procedure (up to 1 hour), after medication administration)
- Procedure Time(up to 1 hour)
- Physician-rated Ease of Use Scale Score(after procedure (approximately 1 minute to complete survey))
- Number of Participants Estimated Blood Loss >500 ml(during procedure (up to 1 hour))
- Clinician Correctly Guessed Group to Which Participant Was Randomized(after procedure (approximately 1 minute to complete survey))