Comparative Effectiveness of Pregnancy Failure Management Regimens
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Gestational Sac Expulsion With One Treatment Dose on Day 3 (Visit 2) and no Need for Additional Medical or Surgical Intervention Within 30 Days of Treatment.
研究概览
简要总结
The purpose of the study is to compare the effectiveness of combination treatment (mifepristone premedication plus single-dose misoprostol) to single-dose misoprostol (standard of care) for the management of early pregnancy failure.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •between 5 and 12 completed weeks gestation
- •18 years or older
- •hemodynamically stable
- •confirmed diagnosis of intrauterine embryonic/fetal demise or anembryonic gestation (ultrasound examination demonstrates a fetal pole without cardiac activity measuring between 5.3 and 40 mm or an abnormal growth pattern diagnostic of early pregnancy failure)
- •willing and able to give informed consent
排除标准
- •diagnosis of incomplete or inevitable abortion (absent gestational sac and/or active bleeding, open cervical os)
- •contraindication to mifepristone (chronic corticosteroid administration, adrenal disease)
- •contraindication to misoprostol (glaucoma, mitral stenosis, sickle cell anemia, or known allergy to prostaglandin)
- •cardiovascular disease (angina, valvular disease, arrhythmia, or cardiac failure)
- •most recent hemoglobin <9.5 g/dL
- •diagnosis of porphyria
- •known clotting defect or receiving anticoagulants
- •pregnancy with an intrauterine device (IUD) in place
- •breastfeeding during the first 7 days of study participation
- •unwilling to comply with the study protocol and visit schedule
- •any evidence of viable pregnancy
- •possibility of ectopic pregnancy
- •known or suspected pelvic infection
- •concurrent participation in any other interventional trial
研究组 & 干预措施
misoprostol plus mifepristone
800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior
干预措施: Mifepristone (Drug)
misoprostol plus mifepristone
800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior
干预措施: Misoprostol (Drug)
misoprostol
800 micrograms of vaginal misoprostol alone
干预措施: Misoprostol (Drug)
结局指标
主要结局
Gestational Sac Expulsion With One Treatment Dose on Day 3 (Visit 2) and no Need for Additional Medical or Surgical Intervention Within 30 Days of Treatment.
时间窗: Day 3 (visit 2) and up to 30 days following visit (to ensure surgical measures were not done
Gestational Sac Expulsion by the Second Follow-up Visit at Day 8
时间窗: Day 8 (visit 3) and up to 30 day to ensure additional measures were not done (surgical)
Uterine Asperation
时间窗: 30 Days
Surgical removal of the miscarriage.
Gestational Sac Expulsion by the 30-day Telephone Call
时间窗: 30 Days
次要结局
- Adverse Event Reported by Participants(30 Days)
- Frequency of Serious Adverse Events Between Study Arms.(30 days)