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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep improvement Therapy group(CBT-I) | Experimental |
| |
| Control group (TAU) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep restriction | Behavioral | Go to bed before 23pm |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Hypertension in pregnancy | Pregnancy induced hypertension (PIH) is hypertension that occurs after 20 weeks of gestation in women with previously normal blood pressure. | From the data of randomization until the date of the end of this pregnancy (up to 50 weeks) |
| Gestational diabetes mellitus | Gestational diabetes mellitus (GDM) is defined as glucose intolerance of variable degree with onset or first recognition during pregnancy | From the data of randomization until the date of the end of this pregnancy (up to 50 weeks) |
| Preterm labor | Preterm labor is parturition that occurs when birth occurs between 28 weeks of gestation and 37 weeks | From the data of randomization until the date of the end of this pregnancy (up to 50 weeks) |
| NICU infants | Neonatal NICU occupancy rate | From the data of randomization until the date of the end of this pregnancy (up to 50 weeks) |
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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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | 110004 | China |
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| Stimulation control |
| Behavioral |
Avoid drugs, alcohol, caffeine, and nicotine |
|
| Cognitive therapy | Behavioral | Listen to 30 minutes of soothing music every night for 8 weeks |
|
| Sleep principles discussion | Behavioral | The principles of sleep hygiene are discussed, but without the application of stimulus control or sleep restriction |
|
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D046110 | Hypertension, Pregnancy-Induced |
| D007752 | Obstetric Labor, Premature |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007744 | Obstetric Labor Complications |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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