An interventional study of Sleep restriction and Stimulation control in Gestational Diabetes, Hypertension in Pregnancy and Preterm Labor, sponsored by Jun Wei. Enrolling by invitation at 1 site in China. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-13.
Sponsored by Jun Wei · Not applicable, Interventional, and Prevention
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.
842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.
This study's planned enrollment of 300 is above the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →This is the only study on the registry with Jun Wei as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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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Behavioral: Sleep restriction · Behavioral: Stimulation control · Behavioral: Cognitive therapy
Behavioral: Sleep principles discussion
Go to bed before 23pm
Avoid drugs, alcohol, caffeine, and nicotine
Listen to 30 minutes of soothing music every night for 8 weeks
The principles of sleep hygiene are discussed, but without the application of stimulus control or sleep restriction
Hypertension in pregnancy
Pregnancy induced hypertension (PIH) is hypertension that occurs after 20 weeks of gestation in women with previously normal blood pressure.
Time frame: 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
Time frame: 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
Time frame: From the data of randomization until the date of the end of this pregnancy (up to 50 weeks)
NICU infants
Neonatal NICU occupancy rate
Time frame: From the data of randomization until the date of the end of this pregnancy (up to 50 weeks)
Plan to share: No
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