Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Patient Satisfaction
研究概览
简要总结
Randomized trial which will aim to evaluate whether prophylactic use of ondansetron and ibuprofen will decrease side effects associated with medical abortion and increase patient satisfaction.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •English speaking
- •female volunteers undergoing medical abortion whether for voluntary interruption of pregnancy or missed abortion
- •Gestational age </= 70 days confirmed via ultrasound
- •Access to a time keeping device
- •Willingness to complete a telephone or in-clinic follow up
排除标准
- •chronic medical problems including but not limited to cardiac conditions, malignancy or organ damage
- •Failed medical abortion resulting in surgical management
- •Known intrauterine infection
- •Known allergy to ondansetron or ibuprofen
- •Subjects chronically receiving analgesic drugs
- •Subjects unable to give consent
- •Subjects taking medications that interact with ondansetron or ibuprofen
研究组 & 干预措施
Standard of care
Administration of ibuprofen or ondansetron only when experiencing pain or nausea respectively post misoprostol administration.
干预措施: Use of ibuprofen and ondansetron at symptom onset post misoprostol administration (Drug)
Prophylactic use
Administration of ibuprofen and ondansetron at the time of misoprostol administration.
干预措施: Prophylactic use of ibuprofen and ondansetron post misoprostol administration (Drug)
结局指标
主要结局
Patient Satisfaction
时间窗: At follow up visit, within 2 weeks from the administration of misoprostol
Determine if prophylactic use of ondansetron and ibuprofen during medical abortion treatment can increase patient satisfaction thereby creating a more favorable outcome. Patient satisfaction will be assessed using a home developed survey. Satisfaction is measured on 5-Likert scale ranging from Very satisfied to Very dissatisfied.
Patient Satisfaction Based on Recommendation of Regimen
时间窗: At follow up visit, within 2 weeks from the administration of misoprostol
Determine if prophylactic use of ondansetron and ibuprofen during medical abortion treatment can increase patient satisfaction based on their likelihood to recommend the regimen. Likelihood to recommend will be assessed using a home developed survey measured on 5-Likert scale ranging from "Extremely likely to recommend" to "Extremely unlikely to recommend" (an additional "I do not know option" will be provided).
次要结局
- Pain Management at 6-8 Hours(Within 6-8 hours from the administration of misoprostol)
- Pain Management at 24 Hours(Within 24 hours from the administration of misoprostol)
- Nausea Management(Within 24 hours from the administration of misoprostol)
- Need for Pain Management Medication.(Within 24 hours from the administration of misoprostol)
- Need for Anti-nausea Medication.(Within 24 hours from the administration of misoprostol)