NCT07268118招募中2 期
Randomized Control Trial for Pain Control With Topical Lidocaine for Cervical Ripening Balloon Placement
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Patient-reported pain during cervical ripening balloon placement.
研究概览
简要总结
No standard of care exists for pain management during cervical ripening balloon placement. The purpose of this study is to evaluate if vaginal topical lidocaine reduces pain related to cervical ripening balloon placement during induction of labor.
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
- 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
- 否
入选标准
- •Age ≥18 years
- •Gestational age ≥37 weeks
- •Viable pregnancy
- •Intact membranes
- •English speaking
- •Interested in cervical ripening balloon placement
- •Able to provide consent
排除标准
- •Allergy or sensitivity to lidocaine
- •Patients that already have neuraxial anesthesia (i.e. spinal, epidural, combined spinal/epidural)
- •Known uterine or cervical anomalies
研究组 & 干预措施
Standard of care
No Intervention
Topical lidocaine
Experimental
干预措施: topical vaginal application lidocaine gel (Drug)
结局指标
主要结局
Patient-reported pain during cervical ripening balloon placement.
时间窗: Within 24 hours of cervical balloon ripening
Patient-reported pain score during cervical ripening balloon placement on a visual analog scale from 0 (no pain) to 10 (most pain).
次要结局
未报告次要终点
研究者
Sarah Little
Associate Professor
Beth Israel Deaconess Medical Center
研究点 (1)
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