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

NCT06687044 | Enrolling By Invitation

• 1 other identifier: Sleep improvement therapy
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gestational Diabetes; Hypertension in Pregnancy; Preterm Labor; NICU Infants

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (2)

Sleep improvement Therapy group(CBT-I)

EXPERIMENTAL

Behavioral: Sleep restriction; Behavioral: Stimulation control; Behavioral: Cognitive therapy

Control group (TAU)

PLACEBO COMPARATOR

Behavioral: Sleep principles discussion

Interventions

Sleep restriction BEHAVIORAL

Go to bed before 23pm

Sleep improvement Therapy group(CBT-I)

Stimulation control BEHAVIORAL

Avoid drugs, alcohol, caffeine, and nicotine

Sleep improvement Therapy group(CBT-I)

Cognitive therapy BEHAVIORAL

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

Sleep improvement Therapy group(CBT-I)

Sleep principles discussion BEHAVIORAL

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

Control group (TAU)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Jun Wei: lead

Study Sites (1)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

Location

MeSH Terms

Conditions

Diabetes, Gestational; Hypertension, Pregnancy-Induced; Obstetric Labor, Premature

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Obstetric Labor Complications

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Gynecology and Obstetrics

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 13, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)