Идёт набор NCT06964373

Cervical Ripening Balloons for Same-Day Cervical Prep

Без фазы С лечением Dilation and Evacuation

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: Cervical Ripening Balloon, Osmotic Dilators.
Кому может быть актуально: Состояния в реестре: Dilation and Evacuation. 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: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Cervical Ripening Balloon for Same-Day Cervical Preparation for Second Trimester Termination

Обзор

The goal of this clinical trial is to learn if a cervical ripening balloon (Foley balloon) works to prepare the cervix before same-day outpatient dilation and evacuation (D\&E). The main questions it aims to answer are: * Is cervical preparation with cervical ripening balloon for same-day outpatient D\&E non-inferior to cervical preparation with osmotic dilators? * How feasible and safe is cervical preparation with cervical ripening balloon for same-day outpatient D\&E? * How acceptable is cervical preparation with cervical ripening balloon for same-day outpatient D\&E? Participants will: * Have cervical preparation with cervical ripening balloon (experimental group) or osmotic dilators (usual care group) * Complete two surveys, one about the cervical preparation and one about the D\&E procedure

Вмешательства

Устройство Cervical Ripening Balloon
30 milliliter Foley balloon
Устройство Osmotic Dilators
Dilapan-S

Первичные конечные точки

D&E procedure length (minutes) [Срок оценки: during procedure]

Вторичные конечные точки (12)

Starting dilation (French gauge) [Срок оценки: during procedure]
Additional dilation (French gauge) [Срок оценки: during procedure]
Estimated blood loss (milliliters) [Срок оценки: during procedure]
Additional sedation medication administered [Срок оценки: during procedure]
Pain (Visual Analog Scale) [Срок оценки: during procedure]
Administration of uterotonic medications [Срок оценки: during procedure]
Cervical laceration [Срок оценки: during procedure]
Estimated blood loss > 500 milliliters [Срок оценки: From enrollment to 24 hours after enrollment]
Hospital transfer [Срок оценки: From enrollment to 24 hours after enrollment]
Feasibility of cervical preparation (physician-reported) [Срок оценки: From enrollment to 24 hours after enrollment]
Likelihood to recommend cervical preparation (participant-reported) [Срок оценки: From enrollment to 24 hours after enrollment]
Acceptability of cervical preparation (physician-reported) [Срок оценки: From enrollment to 24 hours after enrollment]

Критерии участия

Критерии включения

Individuals who desire outpatient dilation and evacuation (D\&E)
At least 18 years of age
Able and willing to consent
Gestational duration between 18 weeks 0 days and 19 weeks 6 days as determined by ultrasound
Able to read and understand English or Spanish
Able to obtain reliable post-procedure transportation
Able to observe fasting guidelines of 6 hours prior to the D\&E procedure