跳至主要内容
临床试验/NCT00592215
NCT00592215撤回1 期

A Pilot Study of Mifepristone Followed by Misoprostol in Women Undergoing Second Trimester Abortion

Johns Hopkins University2 个研究点 分布在 1 个国家开始时间: 2008年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
撤回
试验地点
2
主要终点
Abortion rate

研究概览

简要总结

A superior second trimester medical abortion regimen has not been identified. Studies suggest that a regimen of mifepristone and misoprostol given 36 to 48 hours apart has the shortest median induction-to-abortion interval, highest 24-hour abortion rate, and low rates of adverse events. Narrowing the interval between the two medications without clinically reducing effectiveness may increase access and acceptability for patients and reduce costs. Data from studies on first trimester abortions suggest that the 6 to 8 hour interval between mifepristone and misoprostol is as efficacious as the 36 to 48 hour interval. There are no studies on shorter intervals with same day administration between mifepristone and misoprostol in second trimester abortions.

The primary objective is to assess the efficacy of the combined mifepristone/misoprostol regimen for abortions between 17 0/7 and 23 6/7 weeks' gestation using an interval of 6 to 8 hours between the two medications.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

入选标准

  • English-speaking women
  • 18 years of age and above
  • Voluntarily choose to undergo pregnancy termination via labor induction
  • An ultrasound-confirmed singleton intrauterine pregnancy between 17 0/7 and 23 6/7 weeks gestation
  • Able to provide written consent

排除标准

  • Premature rupture of membranes
  • Preterm labor
  • Intrauterine fetal demise
  • Chronic systemic corticosteroid use or adrenal disease
  • Hypersensitivity to prostaglandins
  • Cardiovascular disease such as angina, valvular disease, arrhythmia, cardiac failure
  • Known coagulopathy or treatment with anticoagulants
  • Prior caesarean delivery or myomectomy
  • Placenta previa

研究组 & 干预措施

A

Experimental

Mifepristone followed by labor induction with misoprostol after 6-8 hours

干预措施: Experimental (mifepristone and misoprostol) (Drug)

结局指标

主要结局

Abortion rate

时间窗: 8 hours after misoprostol administration

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Second Trimester Labor Induction | 临床试验