Topical Anesthesia During Catheter Insertion for Cervical Ripening (TOLERANCE)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Pain levels during insertion
研究概览
简要总结
The goal of this RCT is to learn if application of topical anesthetic cream to the perineum and posterior wall of vagina prior to balloon catheter insertion as part of labor induction will reduce pain levels experienced by pregnant individuals.
All participants are 18 or older, carrying a singleton in vertex position and in need of labor induction, are late-preterm or term (34 weeks gestation and onward) and without contraindication to vaginal delivery.
Investigators seek to compare pain levels and patient satisfaction between two groups:
Nulliparous patients, using EMLA or placebo (randomized, double blinded). Multiparous patients, EMLA or placebo.
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
- Double (Participant, Care Provider)
盲法说明
Both creams (EMLA and placebo) are specially made in similar containers, labeled as A and B. Head of pharmacy in the study's medical center alone is aware which is EMLA or placebo. Both substances are of similar smell, texture and color.
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
- •Women scheduled for labor induction with balloon catheter.
- •18 years of age or older.
- •Singleton pregnancy with a cephalic presentation.
- •≥ 34 completed gestational weeks.
- •Does not participate in any other trial that might affect maternal or fetal/neonatal outcomes.
- •No contraindication for vaginal delivery
排除标准
- •Unable or unwilling to provide and sign informed consent forms.
- •Known sensitivity to EMLA or placebo substance.
- •Known vulvodynia or vaginismus - rendering vaginal examination not possible.
- •Any chronic pain syndrome
研究组 & 干预措施
EMLA
干预措施: Topical Analgesia with Lidocaine-Prilocaine cream (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Pain levels during insertion
时间窗: directly after application and insertion of balloon catheter.
Pain levels during insertion of balloon catheter, as experienced by participant and ranked from 1 to 5 \[1 - no pain at all 2 - mild discomfort 3 -strong pain yet bearable 4 -severe pain 5 - unbearable pain (requires cessation of insertion)\].
次要结局
- analgesia while with balloon catheter(6-12 hours)
- pain score during removal of catheter(to be asked directly after removal, on a scale of 1-5.)
- willingness to undergo cervical ripening with balloon catheter in the future(to be asked directly after removal, on a scale of 1-5.)
- analgesia during delivery(From time of balloon insertion until the time of delivery, assessed up to 3 days and to be checked immediately after delivery.)
- mode of delivery(at delivery)
- neonatal weight(immediately after delivery)
- difficulty of insertion(to be reported by inserting doctor immediately after insertion procedure is completed, estimated up to 20 minutes.)
- APGAR [Appearance (color), Pulse (heart rate), Grimace (reflex irritability), Activity (muscle tone), and Respiration (breathing)] score(up to 10 minutes after delivery)
- cord blood gas(up to 10 minutes after delivery)
- neonatal infection(1st week after delivery)
- Neonatal Intensive Care Unit (NICU) admission(from delivery and up to 1 week)
- duration of insertion procedure(balloon insertion duration, estimated as up to 20 minutes)
- obstetric trauma(up to an hour after delivery)