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

Sponsor
Jun Wei
Study ID
NCT06687044
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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.

Key Dates

First listed
Nov 13, 2024
Start date
Nov 1, 2024
Status verified
Nov 2024
Primary completion
Nov 1, 2026
Completion
Nov 1, 2026

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Sleep improvement Therapy group(CBT-I)
  • Placebo Comparator: Control group (TAU)

Primary Outcome Measure

Hypertension in pregnancy [ Time Frame: From the data of randomization until the date of the end of this pregnancy (up to 50 weeks) ]

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