Идёт набор NCT07288021

Topical Anesthesia During Catheter Insertion for Cervical Ripening (TOLERANCE)

Фаза IV С лечением Labor, Induced

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Topical Analgesia with Lidocaine-Prilocaine cream, Placebo.
Кому может быть актуально: Состояния в реестре: Labor, Induced. Базовые параметры: от 18 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Израиль
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Вмешательства

Препарат Topical Analgesia with Lidocaine-Prilocaine cream
patients allocated to \'EMLA\' arm will receive topical analgesia cream prior to speculum insertion, as part of the administration of balloon catheter insertion process. 3 puffs of the cream will be applied to the perineum, posterior fourchette and posterior vaginal wall by administrating physician. A pause of 7 minutes in the process will be made to allow for maximal analgesic affect.
Другое Placebo
patients allocated to \'Placebo\' arm will receive lubrication with placebo cream prior to speculum insertion, as part of the administration of balloon catheter insertion process. 3 puffs of the cream will be applied to the perineum, posterior fourchette and posterior vaginal wall by administrating physician. A pause of 7 minutes in the process will be made.

Первичные конечные точки

Pain levels during insertion [Срок оценки: directly after application and insertion of balloon catheter.]

Вторичные конечные точки (12)

analgesia while with balloon catheter [Срок оценки: 6-12 hours]
pain score during removal of catheter [Срок оценки: to be asked directly after removal, on a scale of 1-5.]
willingness to undergo cervical ripening with balloon catheter in the future [Срок оценки: to be asked directly after removal, on a scale of 1-5.]
analgesia during delivery [Срок оценки: 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 [Срок оценки: at delivery]
neonatal weight [Срок оценки: immediately after delivery]
APGAR [Appearance (color), Pulse (heart rate), Grimace (reflex irritability), Activity (muscle tone), and Respiration (breathing)] score [Срок оценки: up to 10 minutes after delivery]
cord blood gas [Срок оценки: up to 10 minutes after delivery]
Neonatal Intensive Care Unit (NICU) admission [Срок оценки: from delivery and up to 1 week]
neonatal infection [Срок оценки: 1st week after delivery]
duration of insertion procedure [Срок оценки: balloon insertion duration, estimated as up to 20 minutes]
difficulty of insertion [Срок оценки: to be reported by inserting doctor immediately after insertion procedure is completed, estimated up to 20 minutes.]

Критерии участия

Критерии включения

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