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Идёт набор NCT07265518

Outpatient Induction of Labour Using a Double Balloon Transcervical Catheter in Low-risk Pregnant Women: a Two-centre Open Prospective Randomised Controlled Trial - OutCRIB

Без фазы С лечением Pregnant Women

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: Outpatient, Inpatient.
Кому может быть актуально
Состояния в реестре: Pregnant Women. 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
Франция
Следующий шаг
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Обзор

The aim goal of this study is to compare the duration of induction and labor between outpatient and inpatient care in low-risk pregnant women. The secondary objectives are to compare between the two groups the maternal satisfaction from induction to delivery, the maternal and neonatal morbidity and mortality, impact on service organization and a medico-economic evaluation (cost-consequence analysis) from a collective perspective and with a time horizon of one month For women who do not agree to take part in the randomized study, an observational study will be proposed to them in order to collect the reason for their refusal and their maternal satisfaction. Researchers will compare the return home with conventional hospitalization Patients presenting with a singleton pregnancy and with an indication for induction of labor will be proposed to participate in the study. If the pregnant woman refuses to participate in the randomized study, she will be invited to take part in the observational study. For women who accept, a fetal heart rate recording (FHRR) is made prior to balloon insertion. If there is no fetal heart rhythm abnormality (FHR), the double balloon catheter is inserted by a midwife. A further ERCF is performed to ensure that the procedure is well tolerated. In the absence of metrorrhagia, fetal heart rate abnormalities, rupture of the water sac or uterine hypertonia/hyperkinesia, the patient will then be randomized to either the in-patient or out-patient arm. The patient will either be placed in a room or go home. In both cases, the balloon will be removed after 24 hours in hospital in the absence of spontaneous labor, and the patient will be referred to the delivery room for water breakage and/or oxytocin infusion for induction.

Вмешательства

  • Другое Outpatient
    Women return at home
  • Другое Inpatient
    Women stay at hospital

Первичные конечные точки

  • compare the duration of induction and labor between outpatient and inpatient care. [Срок оценки: 72 hours]
Вторичные конечные точки (5)
  • Compare maternal satisfaction from induction to delivery between the two groups outpatient and inpatient via EXIT questionnaire [Срок оценки: 48 hours]
  • Compare maternal morbidity and mortality between the two groups outpatient and inpatient [Срок оценки: 48 hours]
  • Compare neonatal morbidity and mortality between the two groups outpatient and inpatient [Срок оценки: 48 hours]
  • Compare the number of hospital beds freed up and the number of concurrent induction in the department [Срок оценки: 24 hours]
  • Compare medico-economic evaluation (cost-consequence analysis) from a collective perspective and with a time horizon of one month between the two groups outpatient and inpatient [Срок оценки: 1 month]

Критерии участия

Критерии включения

  • Pregnant woman with singleton pregnancy in cephalic presentation
  • Term ≥ 37SA+0d
  • Age ≥ 18 years
  • Affiliated or beneficiary of a social security scheme
  • No severe maternal/neonatal pathology (severe pre-eclampsia, intra-uterine growth retardation, etc.)
  • Indication for balloon induction
  • Bishop score <6
  • Home-hospital distance ≤ 30 minutes' drive
  • Presence of a family member at the woman's side to help her return home

Критерии исключения

  • Scarred uterus
  • Fetal heart rhythm abnormalities
  • Rupture of membranes
  • Death in utero
  • Placenta previa or adherent placenta (accreta or percreta)
  • Maternal respiratory, cardiac, hepatic, renal, digestive or decompensated psychiatric pathology
  • Anamnios
  • Patient under guardianship, curatorship and/or safeguard of justice

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Франция · 2 центра
  • CHU de Nantes — Nantes
  • CHD Vendée — La Roche-sur-Yon

Идентификаторы

NCT: NCT07265518 · RC24_0036 · 2024-A02122-45

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗