PACTR202209466217416招募中未知
Effectiveness and Acceptability of two models of an Insertable Vaginal Cup for Non-surgical management of obstetric fistula in Ghana: a hybrid type 1 randomized crossover trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 13 Year(s) 至 18 Year(s)（—）
- 性别
- Female
入选标准
- •VVF confirmed by dye test and clinical exam at least 3cm from the external urethral orifice (regardless of size), adequate vaginal capacity to accommodate the cup (per physician)
- •Willing to insert and remove cup/cup+
- •Clear understanding of the study procedures
- •Willing to participate fully, not yet been repaired or previously failed surgical repair, at least 6mo post-surgery
- •If previous fistula repair, =3mo post-delivery
- •If recent birth, age 18+ or emancipated minor
- •Speak English or local language
排除标准
- •Any rectovaginal fistula
- •Women who are candidates for catheterization who could be healed without surgery will be excluded as they are <3mo post-delivery.
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