Набор скоро начнётся NCT06691945

Prophylactic Amnioinfusion for Prevention of Postpartum Hemorrhage

Фаза III С лечением Postpartum Hemorrhage

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: Saline delivered using an intrauterine pressure catheter (IUPC).
Кому может быть актуально: Состояния в реестре: Postpartum Hemorrhage. 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

Prophylactic Amnioinfusion for Prevention of Postpartum Hemorrhage: A Randomized Clinical Trial (PURPOSE)

Обзор

The purpose of this study is to decrease the likelihood of composite postpartum hemorrhage (PPH) morbidity, which consists of i) Estimated or quantified blood loss of 1,500 mL or more, ii) transfusion of any blood products or iii) hysterectomy

Вмешательства

Комбинированный продукт Saline delivered using an intrauterine pressure catheter (IUPC)
An intrauterine pressure catheter (IUPC) will be placed in participants after membrane rupture, or at 4 cm if membranes previously ruptured. A 300cc bolus of normal saline will be administered. A continuous rate of 100 cc/hr of normal saline will continue until delivery to prevent Postpartum Hemorrhage. If the IUPC is dislodged, it will be replaced by a trained clinician.

Первичные конечные точки

Number of participants who have estimated or quantified blood loss of 1,500 mL or more [Срок оценки: from delivery admission to discharge (average of 3 days post delivery)]
Number of participants who have transfusion of any blood products [Срок оценки: from delivery admission to discharge or up to 12 weeks post delivery]
Number of participants who have hysterectomy [Срок оценки: from delivery admission to discharge or up to 12 weeks post delivery]

Вторичные конечные точки (12)

Number of mothers who use uterotonics, in addition to oxytocin [Срок оценки: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period]
Estimated blood loss(mL) [Срок оценки: post delivery (from immediately after delivery to upto 2 hours after delivery)]
Quantitative blood loss(mL) [Срок оценки: post delivery(from immediately after delivery to upto 2 hours after delivery)]
Delta change in hemoglobin of mothers [Срок оценки: pre delivery, post partum day 1]
Number of mothers who have cesarean deliveries [Срок оценки: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period]
Number of mothers who need Mechanical tamponade [Срок оценки: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period]
Number of mothers who have surgical interventions (O'Leary, B 'Lynch or uterine arterial embolization) [Срок оценки: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period]
Number of mothers who have Chorioamnionitis [Срок оценки: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period]
Number of mothers who have endometritis [Срок оценки: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period]
Number of mothers who have wound complications (if cesarean delivery) [Срок оценки: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period]
Number of mothers who are admitted to intensive care unit [Срок оценки: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period]
Number of deaths [Срок оценки: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period]

Критерии участия

Критерии включения

Singletons with a gestational age of 34.0 weeks or more
Labor (spontaneous or medical induction)
Medium- or High-risk for PPH, as described by American College of Obstetricians and Gynecologists (ACOG)