NOPE37: Angiogenic Factors for Managing Term Preeclampsia
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: Intervention arm: expectant management if sFlt-1/PlGF<38, Standard care: elective delivery at 37 weeks of gestation.
- Кому может быть актуально
- Состояния в реестре: Preeclampsia. 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
- Испания
- 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
Angiogenic Markers for Confirming Term Preeclampsia (noPE-37 Trial): An Open-Label, Randomized Controlled Trial
Обзор
This study tests the hypothesis that, in women with preeclampsia without severe features, delivery management based on sFlt-1/PlGF would reduce the rate of induction of labor without worsening the rate of progression to preeclampsia with severe features and other maternal complications.
Подробное описание
Participants with preeclampsia without severe features between 36 and 38+6 weeks, who do not meet any exclusion criteria, will be randomly assigned to two groups:
* In the study group, if angiogenic factors are normal (sFlt-1/PlGF \<38), delivery will be delayed until 39 weeks; if any other medical condition is present, delivery will be scheduled according to the specific protocol for it. * In the study group, if angiogenic factors are abnormal (sFlt-1/PlGF ≥38), labor will be induced at ≥37 weeks. * In the control group, labor will be recommended at 37 weeks, as is currently standard. * In both groups, NT-proBNP levels will be measured at enrollment. * In both groups, a satisfaction questionnaire will be completed at enrollment and 4 weeks after delivery. * In both groups, if any of the following is present, delivery will be recommended immediately (within 24 hours):
1. preeclampsia with severe features according to ACOG criteria 2. decreased fetal movements 3. absent or reversed diastolic flow in the umbilical artery 4. non-reassuring CTG 5. biophysical profile score ≤6 6. oligohydramnios (largest vertical pocket \<2 cm)
Вмешательства
- Другое Intervention arm: expectant management if sFlt-1/PlGF<38
If the angiogenic factors are normal (sFlt-1/PlGF \<38), expectant management will be followed until 39 weeks, instead of delivery at ≥37 weeks of gestation as in standard care for preeclampsia without severe features. - Другое Standard care: elective delivery at 37 weeks of gestation
In the control arm, standard care for preeclampsia without severe features will be followed: elective delivery at ≥37 weeks of gestation.
Первичные конечные точки
- Composite maternal outcome [Срок оценки: through study completion, an average of 2 months]
Вторичные конечные точки (12)
- Neonatal morbidity [Срок оценки: through study completion, an average of 2 months]
- Method of delivery [Срок оценки: through study completion, an average of 2 months]
- Maternal admission to ICU [Срок оценки: through study completion, an average of 2 months]
- Days of maternal admission to ICU [Срок оценки: through study completion, an average of 2 months]
- Gestational age at delivery [Срок оценки: through study completion, an average of 2 months]
- Birthweight [Срок оценки: through study completion, an average of 2 months]
- Birthweight percentile [Срок оценки: through study completion, an average of 2 months]
- Prematurity [Срок оценки: through study completion, an average of 2 months]
- Days of neonatal admission to NICU [Срок оценки: through study completion, an average of 2 months]
- Metabolic acidosis [Срок оценки: through study completion, an average of 2 months]
- Need of maternal corticosteroids [Срок оценки: through study completion, an average of 2 months]
- Maternal NT-proBNP levels [Срок оценки: through study completion, an average of 2 months]
Критерии участия
Критерии включения
- Age ≥18 years
- Singleton pregnancy
- Preeclampsia without severe features according to the ACOG definition
- Antegrade diastolic flow in the umbilical artery Doppler
- Gestational age between 36+0 and 38+6 weeks of gestation
- Gestational age confirmed by fetal crown-rump length measurement in the first-trimester scan (from 11+0 to 13+6 weeks of gestation) or by in vitro fertilization dates
Критерии исключения
- Fetal death
- Preeclampsia with severe features according to the ACOG definition, eclampsia, or any condition that requires immediate delivery
- Absent or reversed end-diastolic flow in the umbilical artery Doppler
- Non-reassuring CTG
- Decreased fetal movements
- Biophysical profile score ≤6
- Oligohydramnios
- Refusal to provide informed consent
- Fetal malformation
- Placental abruption
- Antiphospholipid antibody syndrome
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
- Лечение
Центры проведения
Испания · 23 центра
- Hospital Universitari Dexeus — Barcelona
- Hospital Universitario de A Coruña — A Coruña
- Hospital General Universitari Dr. Balmis — Alicante
- Vall d'Hebron Hospital Campus — Barcelona
- Hospital Universitario de Cabueñes — Cabueñes
- Hospital Universitario Puerta del Mar — Cadiz
- Hospital General Universitario de Elche — Elche
- Hospital Universitario de Getafe — Getafe
- … и ещё 15 центров
Идентификаторы
NCT: NCT07193680 · PR(AMI)392-2023