Sleep Improvement Therapy Affects Pregnancy Outcomes in Chinese Singletons and Twins by Improving Sleep Quality
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sleep restriction, Stimulation control, Cognitive therapy, Sleep principles discussion.
- Who it may be relevant to
- Registry conditions: Gestational Diabetes, Hypertension in Pregnancy, Preterm Labor, NICU Infants. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral Sleep restriction
Go to bed before 23pm - Behavioral Stimulation control
Avoid drugs, alcohol, caffeine, and nicotine - Behavioral Cognitive therapy
Listen to 30 minutes of soothing music every night for 8 weeks - Behavioral Sleep principles discussion
The principles of sleep hygiene are discussed, but without the application of stimulus control or sleep restriction
Primary outcome measures
- Hypertension in pregnancy [Time frame: From the data of randomization until the date of the end of this pregnancy (up to 50 weeks)]
- Gestational diabetes mellitus [Time frame: From the data of randomization until the date of the end of this pregnancy (up to 50 weeks)]
- Preterm labor [Time frame: From the data of randomization until the date of the end of this pregnancy (up to 50 weeks)]
- NICU infants [Time frame: From the data of randomization until the date of the end of this pregnancy (up to 50 weeks)]
Eligibility criteria
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
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Shengjing Hospital of China Medical University — Shenyang
Identifiers
NCT: NCT06687044 · Sleep improvement therapy