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Набор по приглашению NCT06687044

Sleep Improvement Therapy Affects Pregnancy Outcomes in Chinese Singletons and Twins by Improving Sleep Quality

Без фазы С лечением Gestational Diabetes Hypertension in Pregnancy Preterm Labor NICU Infants

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: Sleep restriction, Stimulation control, Cognitive therapy, Sleep principles discussion.
Кому может быть актуально
Состояния в реестре: Gestational Diabetes, Hypertension in Pregnancy, Preterm Labor, NICU Infants. Базовые параметры: 18 лет — 45 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
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Обзор

During pregnancy, the physical and psychological changes of pregnant women, hyperemesis gravidarum, uterine compression, frequent urination, hip or pelvic pain, back pain, leg cramps, gastroesophageal reflux, changes in mental state, and even changes in lifestyle, habits and tastes may affect the sleep of pregnant women. Due to the coexistence of physiological, psychological, social and other complex factors during pregnancy, the incidence of sleep disorders in pregnant women is relatively high, up to 50%, and shows an increasing trend with the increase of gestational week. Not only seriously affect the quality of life of pregnant women, but also may lead to a variety of pregnancy complications, and even lead to adverse pregnancy outcomes. Therefore, early identification, timely diagnosis and treatment of sleep disorders during pregnancy are important measures to improve or even reverse adverse pregnancy outcomes. Although sleep disorders are more common and seriously harmful during pregnancy, people lack of understanding and attention to such diseases, and often regard them as normal clinical manifestations of pregnancy and neglect diagnosis and treatment. Studies have shown that maternal sleep disorders are associated with hypertensive disorders during pregnancy, preterm birth, and gestational diabetes. Current research objects mainly focus on single pregnancy, twin related research is less. The purpose of this study is to explore the perinatal sleep health of pregnant women with twin pregnancies, reduce the complications of pregnant women with twin pregnancies and improve the pregnancy outcomes of mothers and infants by improving sleep quality.

Вмешательства

  • Поведенческое Sleep restriction
    Go to bed before 23pm
  • Поведенческое Stimulation control
    Avoid drugs, alcohol, caffeine, and nicotine
  • Поведенческое Cognitive therapy
    Listen to 30 minutes of soothing music every night for 8 weeks
  • Поведенческое Sleep principles discussion
    The principles of sleep hygiene are discussed, but without the application of stimulus control or sleep restriction

Первичные конечные точки

  • Hypertension in pregnancy [Срок оценки: From the data of randomization until the date of the end of this pregnancy (up to 50 weeks)]
  • Gestational diabetes mellitus [Срок оценки: From the data of randomization until the date of the end of this pregnancy (up to 50 weeks)]
  • Preterm labor [Срок оценки: From the data of randomization until the date of the end of this pregnancy (up to 50 weeks)]
  • NICU infants [Срок оценки: From the data of randomization until the date of the end of this pregnancy (up to 50 weeks)]

Критерии участия

Inclusion Criteria: (1) Pregnant women aged 18-45 years. (2) Diagnosed with single or twin pregnancy within 12 weeks of pregnancy, report sleep quality problems, agree to participate in the study and sign the informed consent -

Exclusion Criteria:Have a prior serious underlying medical condition (e.g., diabetes, heart disease), mental illness, or other serious sleep disorder

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Профилактика

Центры проведения

Китай · 1 центр
  • Shengjing Hospital of China Medical University — Шэньян

Идентификаторы

NCT: NCT06687044 · Sleep improvement therapy

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗