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Clinical Trials in China / NCT06687044
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Sleep Improvement Therapy Affects Pregnancy Outcomes in Chinese Singletons and Twins by Improving Sleep Quality

NCT06687044 · tracked via the Priya Life Science China tracker
Sponsor
Jun Wei
Phase
Not applicable
Started
2024-11-01
Last updated
2024-11-13

Condition(s) studied

Gestational DiabetesHypertension in PregnancyPreterm LaborNICU Infants

Investigational drug(s) / intervention(s)

Sleep restrictionStimulation controlCognitive therapySleep principles discussion

Sleep restriction: Go to bed before 23pm

Stimulation control: Avoid drugs, alcohol, caffeine, and nicotine

Cognitive therapy: Listen to 30 minutes of soothing music every night for 8 weeks

Sleep principles discussion: The principles of sleep hygiene are discussed, but without the application of stimulus control or sleep restriction

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
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 \-

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shengjing Hospital of China Medical University Shenyang Liaoning

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06687044 on ClinicalTrials.gov ↗ ← All trials in China