Набор скоро начнётся NCT06217913

Effects of Monitoring Blood Pressure During Pregnancy

Без фазы С лечением Birth Weight Weight Gain Trajectory

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: wearable device to monitor the blood pressure.
Кому может быть актуально: Состояния в реестре: Birth Weight, Weight Gain Trajectory. Базовые параметры: 18 лет — 60 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: Китай
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

Effects of Monitoring Blood Pressure in High-risk Pregnant Women Using a Wearable Device

Обзор

In this study, at least 400 women with high-risk of pregnancy hypertension will use a wearable device to monitor the blood pressure during gestational age from 12 weeks to 28weeks. The observed outcomes including maternal and offspring. Participants were from three hospital including Shanghai Xinhua Hospital, Jiaxing Maternal and Child Health Hospital and Peking University Third Hospital. Pregnant women were randomly divided into control group (routine delivery examination group) and intervention group (routine delivery examination group + use of wearable blood pressure monitoring device group), 200 cases each.

Вмешательства

Устройство wearable device to monitor the blood pressure
Pregnant women began to establish antenatal examination records (usually before 12 weeks of pregnancy), and were enrolled through randomized grouping. Pregnant women in the intervention group were provided with wearable blood pressure monitoring equipment, and ambulate blood pressure monitoring was conducted for at least 2 24 hours per week from 12 weeks of pregnancy until 28 weeks of pregnancy, after which blood pressure monitoring was carried out according to routine antenatal examination.

Первичные конечные точки

Offspring weight change [Срок оценки: up to 24 months]

Вторичные конечные точки (5)

Maternal blood pressure change [Срок оценки: 16 weeks]
Maternal complications [Срок оценки: 28 weeks]
Offspring outcomes [Срок оценки: up to 24 months]
Offspring neurodevelopment [Срок оценки: up to 24 months]
Offspring perinatal outcomes [Срок оценки: up to 24 months]

Критерии участия

Критерии включения

Women with a single pregnancy before 12 weeks of pregnancy
The presence of any of the following risk factors: age > 30 years, a history of eclampsia, a family history of eclampsia, obesity (BMI ≥ 30 Kg/m2), and a history of gestational hyperglycemia (pregestational type 1 and type 2 diabetes; gestational manifest diabetes and gestational diabetes requiring insulin treatment), preexisting chronic hypertension, kidney disease, and autoimmune diseases such as systemic lupus erythematosus and antiphospholipid syndrome.
Signed the informed consent can be continuously followed up.
Permanent population living in the study area.
All subjects received routine antenatal examination and treatment.