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NCT Number: NCT06687044

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

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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Key information

Conditions

Gestational Diabetes Cardiovascular Diseases Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hypertension Hypertension in Pregnancy Hypertension, Pregnancy-Induced Metabolic Diseases NICU Infants Nutritional and Metabolic Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Preterm Labor Urogenital Diseases Vascular Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Sleep Restriction

Behavioral

Go to bed before 23pm

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

Primary outcomes

  1. Hypertension in pregnancy

    Time frame: 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.

  2. Gestational diabetes mellitus

    Time frame: 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

  3. Preterm labor

    Time frame: 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

  4. NICU infants

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

    Neonatal NICU occupancy rate

Sponsors and collaborators

Lead sponsor

Jun Wei

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 13, 2024
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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