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临床试验/NCT06687044
NCT06687044Enrolling By Invitation不适用

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

Jun Wei1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
300
试验地点
1
主要终点
Hypertension in pregnancy

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •(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 -

排除标准

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

研究组 & 干预措施

Control group (TAU)

Placebo Comparator

干预措施: Sleep principles discussion (Behavioral)

Sleep improvement Therapy group(CBT-I)

Experimental

干预措施: Cognitive therapy (Behavioral)

Sleep improvement Therapy group(CBT-I)

Experimental

干预措施: Sleep restriction (Behavioral)

Sleep improvement Therapy group(CBT-I)

Experimental

干预措施: Stimulation control (Behavioral)

结局指标

主要结局

Hypertension in pregnancy

时间窗: From the data of randomization until the date of the end of this pregnancy (up to 50 weeks)

Pregnancy induced hypertension (PIH) is hypertension that occurs after 20 weeks of gestation in women with previously normal blood pressure.

Gestational diabetes mellitus

时间窗: From the data of randomization until the date of the end of this pregnancy (up to 50 weeks)

Gestational diabetes mellitus (GDM) is defined as glucose intolerance of variable degree with onset or first recognition during pregnancy

Preterm labor

时间窗: From the data of randomization until the date of the end of this pregnancy (up to 50 weeks)

Preterm labor is parturition that occurs when birth occurs between 28 weeks of gestation and 37 weeks

NICU infants

时间窗: From the data of randomization until the date of the end of this pregnancy (up to 50 weeks)

Neonatal NICU occupancy rate

次要结局

未报告次要终点

研究者

发起方
Jun Wei
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jun Wei

Department of Gynecology and Obstetrics

Shengjing Hospital

研究点 (1)

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