Transvaginal Versus Transabdominal Digoxin Prior to Second-trimester Abortion: a Pilot Study of Patient Preference
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
- 是
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
Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion
干预措施: Digoxin (transvaginal administration) (Drug)
Transabdominal digoxin
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
