Идёт набор NCT05290129

Oxytocin Maintenance Infusion in Labouring Women Undergoing Cesarean Delivery: an Up-down Sequential Allocation Study

Без фазы 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: Oxytocin.
Кому может быть актуально: Состояния в реестре: Postpartum Hemorrhage. Базовые параметры: 18 лет — 50 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: Канада
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This study is designed to determine the minimal effective oxytocin maintenance infusion required in labouring women undergoing cesarean delivery to achieve the best effect. Oxytocin is a drug that is routinely used to help the uterus to contract and keep it contracted after delivery. Consequently, it will help to reduce blood loss after delivery. In order to determine the minimal effective dose, the investigators will conduct a dose-finding study. The first patient will receive a set oxytocin infusion. The next patient's infusion dose of oxytocin, will either increase or decrease, depending on how the previous patient responds in terms of uterine tone. If the response is satisfactory with the infusion dose used, the next patient will either receive the same infusion dose or it will be decreased depending on a probability of 1:9. If the response is not satisfactory, then the infusion dose will increase for the next patient. The dose for each patient will be determined based on the results of the uterine contraction of the previous patient. The investigators hypothesize that the ED90 of the oxytocin infusion rate to maintain adequate uterine tone in labouring women with induced or augmented labour undergoing cesarean delivery, following an initial effective bolus dose, would be lower than 0.74 IU/min (44 IU/h), which was found as the ED90 in a previous study, without an initial bolus dose prior to the infusion.

Подробное описание

This study will be conducted as a prospective, double blinded clinical trial (patient, anesthesiologist and obstetrician blinded to the oxytocin dose), in an up-down sequential allocation fashion. The objective of the study is to determine the minimum effective dose of oxytocin infusion required to produce appropriate uterine contraction during and after cesarean delivery under neuraxial anesthesia in laboring women. For the purpose of this study, the minimum effective dose is defined to be that at which adequate response occurs in 90% of patients, i.e. ED90.

Вмешательства

Препарат Oxytocin
Oxytocin will be prepared in a 1L bag of Ringer's lactate, to be infused at a rate of 125 ml/h.

Первичные конечные точки

Uterine tone up to discharge from the post anesthetic care unit (PACU): questionnaire [Срок оценки: 2 hours]

Вторичные конечные точки (12)

Calculated blood loss [Срок оценки: 24 hours]
Need for blood transfusion [Срок оценки: 24 hours]
Episodes of bleeding postpartum [Срок оценки: 24 hours]
Intraoperative requirement for additional uterotonic medication [Срок оценки: 1 hour]
Requirement for additional uterotonic medication in the PACU [Срок оценки: 2 hours]
Requirement for additional uterotonic medication from discharge from the PACU until 24 hours postpartum. [Срок оценки: 24 hours]
Hypotension: systolic blood pressure less than 80% of baseline [Срок оценки: 2 hours]
Hypertension: systolic blood pressure greater than 120% of baseline [Срок оценки: 2 hours]
Tachycardia: heart rate greater than 130% of baseline [Срок оценки: 2 hours]
Bradycardia: heart rate less than 70% of baseline [Срок оценки: 2 hours]
Presence of ventricular tachycardia: ECG [Срок оценки: 2 hours]
Presence of atrial fibrillation: ECG [Срок оценки: 2 hours]

Критерии участия

Критерии включения

All patients with induced or augmented labour undergoing cesarean delivery under neuraxial anesthesia (at least 3 hours of prior exposure to oxytocin during labour)