The Effect of Prophylactic Ibuprofen Versus Placebo on Pain Relief and Success Rates of Medical Abortion: A Double-blind Randomized Placebo Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- • Decrease in pain as assessed using an 11-point numeric pain scale from 0 (= no pain) to 10 (=most severe pain).
研究概览
简要总结
In the current study, we want to evaluate the prophylactic use of ibuprofen versus a placebo for medical abortion by mifepristone and misoprostol, at a gestational age of up to 7 weeks, in regard to the effect on pain relief and the overall procedure success.
expected results:
The prophylactic use of NSAIDs could offer significant pain relief and thereby a reduction in the need for additional pain relievers compared to the placebo, without interfering with the outcome of medical abortion
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Good general health
- •Pregnancy of up to 7 weeks gestation.
- •Approval from the Ministry of Health committee for termination of pregnancy after an intrauterine pregnancy was demonstrated by an ultrasound exam.
- •Subjects that provided informed consent and agree to comply with all study procedures.
排除标准
- •Known allergy to mifepristone, misoprostol, paracetamol or NSAIDs.
- •Severe anemia.
- •Drug or alcohol abuse
- •Known abnormal liver function (liver function tests greater than 1.5 times upper range of normal).
- •Known abnormal renal function (serum creatinine > 1.5 mg/dl).
- •Abnormal blood tests
- •Exclusionary health problems contraindicating mifepristone included adrenal disease; sickle cell anemia; severe liver, respiratory, or renal disease; and blood clotting defect.
- •Chronic disease
- •Patient is participating currently in another clinical trial
研究组 & 干预措施
ibuprofen
the group will receive 2 tablets of ibuprofen 400 mg at the time of misoprostol administration. The information about the effect of the analgesics on the pain, and on the course of medical abortion, will be prospectively gathered from questionnaires completed by the study participants
干预措施: ibuprofen (Drug)
结局指标
主要结局
• Decrease in pain as assessed using an 11-point numeric pain scale from 0 (= no pain) to 10 (=most severe pain).
时间窗: 2 weeks
次要结局
- • Success of medical abortion as assessed by follow-up ultrasound examination and the frequency of surgical intervention was recorded.(2 weeks)
研究者
Prof. Daniel Seidman
Senior Physician
Sheba Medical Center