跳至主要内容
临床试验/NCT02277249
NCT02277249已完成不适用

Transvaginal Versus Transabdominal Digoxin Prior to Second-trimester Abortion: a Pilot Study of Patient Preference

University of California, Los Angeles0 个研究点目标入组 60 人开始时间: 2012年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
主要终点
Patient Discomfort With Digoxin Injection (Pain Score)

研究概览

简要总结

Current practice for the provision of late second trimester abortion (dilation and evacuation, or D&E) often involves the administration of digoxin into the fetal compartment to induce fetal demise prior to the procedure. Digoxin may be administered transabdominally or transvaginally into the fetal compartment. Both modes of administration have been shown in prospective studies to be highly effective and safe. Both modes of administration are considered standard of care. This pilot study will directly compare transabdominal and transvaginal digoxin with respect to patient preference (i.e, patient pain score describing discomfort with injection).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age greater than or equal to 18 years
  • Singleton viable gestation
  • Identifying as primarily English-speaking
  • Body mass index less than 40 kilograms/meters squared
  • Already a consented patient for second-trimester abortion procedure with digoxin to be performed for termination of pregnancy at the study site
  • No medical contraindication to digoxin (i.e., no cardiac dysfunction, no renal dysfunction, no hypersensitivity to digoxin)

排除标准

  • 未提供

研究组 & 干预措施

Transvaginal digoxin

Other

Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion

干预措施: Digoxin (transvaginal administration) (Drug)

Transabdominal digoxin

Other

Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion

干预措施: Digoxin (transabdominal administration) (Drug)

结局指标

主要结局

Patient Discomfort With Digoxin Injection (Pain Score)

时间窗: At time of study (immediate)

Pain score (indicated by patient reporting pain level from 0 ("no hurt") to 5 ("hurts worst") at time of digoxin injection)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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