Меню
Набор скоро начнётся NCT07577388

Bed Rest With a Short Cervix on Preterm Birth

Без фазы С лечением Preterm Birth Cervical Insufficiency Bed Rest Pregnancy Complications

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: Activity Restriction, No Activity Restriction.
Кому может быть актуально
Состояния в реестре: Preterm Birth, Cervical Insufficiency, Bed Rest, Pregnancy Complications. 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

BEWISE - Bed Rest With a Short Cervix on Preterm Birth

Обзор

Maternal AR has long been used to prevent PTB. However, definitions of AR vary widely, ranging from complete bed rest to partial limitation of physical activity for one or more hours daily. The use of maternal AR to prevent preterm birth is largely based on observational evidence linking strenuous physical activity to an increased risk of preterm birth, and the assumption that reduced activity may decrease myometrial activity. However, the existing evidence on the clinical effects of AR remains limited and has not demonstrated a reduction in preterm birth or a delay in deliv-ery. In contrast, some studies suggest a potential increase in preterm birth following AR and instead significant adverse maternal and fetal effects. The overall aim of this study is to compare gestational age at birth in women with a short cervix who are prescribed AR compared with women with a short cervix who are not prescribed AR (NAR). The primary hypothesis is that NAR is non-inferior to AR in prolonging pregnancy in women with a short cervix. Secondary hypotheses are that, compared with AR, NAR is associated with higher level of physical activity, lower risk of maternal depression, and reduced risk of loss of maternal bone mineral density. Through the BEWISE study, we wish to implement a change in the Danish national clinical practice regarding AR from recommending AR in risk groups (current practice) to no longer recommending AR as part as routine care (new practice). We will evaluate this change in clinical practice by prospectively collecting data from women both before and after implementation of the new recommendation. The transition from AR to NAR will be implemented sequentially in each Danish region using a randomised stepped-wedge (SW) cluster design, with each region constituting a cluster. The order in which regions transition is determined by randomisation. Each region will adopt the new recommendation at 3-month intervals, resulting in full national transition from AR to NAR within 12 months Eligible participants are pregnant women in gestational age 20+0 to 33+6 and cervical length \< 25 mm in singleton pregnancies and \< 30 mm in multiple pregnancies. Participants must be above 18 years of age and be able to read and understand Danish or English. There are no exclusion criteria. The primary outcome is gestational age in days (continuous).

Вмешательства

  • Поведенческое Activity Restriction
    Recommendation to restrict physical activity in pregnant women with a short cervix. This may include increased rest or bed rest according to local clinical practice.
  • Поведенческое No Activity Restriction
    Recommendation to continue normal daily activity in pregnant women with a short cervix, without restricting physical activity.

Первичные конечные точки

  • Gestational age at birth [Срок оценки: At birth (from inclusion until delivery)]
Вторичные конечные точки (12)
  • Birth before 37 weeks of gestation [Срок оценки: At birth]
  • Gestational age at birth, pooled [Срок оценки: At birth (from inclusion until delivery)]
  • Latency from inclusion to birth (days) [Срок оценки: At birth (from inclusion until delivery)]
  • Onset of birth [Срок оценки: At birth (from inclusion until delivery)]
  • Mode of birth [Срок оценки: At birth (from inclusion until delivery)]
  • - Non-occipital presentation [Срок оценки: At birth (from inclusion until delivery)]
  • Interventions during birth [Срок оценки: At birth (from inclusion until delivery)]
  • Degree of birth tear [Срок оценки: At birth (from inclusion until delivery)]
  • Maternal serious morbidity [Срок оценки: From inclusion to 42 days after delivery]
  • Umbilical cord arterial pH [Срок оценки: At birth (from inclusion until delivery)]
  • EPDS depression score [Срок оценки: From inclusion to 8 weeks after due date]
  • Bone turnover marker level [Срок оценки: At inclusion and after 4 and 8 weeks.]

Критерии участия

Pregnant women with gestational age 20+0 to 33+6

  • Cervical length < 25 mm in singleton pregnancies and < 30 mm in multiple pregnancies
  • Above 18 years of age
  • Reads and understands Danish or English

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07577388 · 16-0500-15 · 4308-00216B · 1-10-72-96-25

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗