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

NCT06687044 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-11-13

No results posted yet for this 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.

Conditions

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

Interventions

BEHAVIORAL

Sleep restriction

Go to bed before 23pm

BEHAVIORAL

Stimulation control

Avoid drugs, alcohol, caffeine, and nicotine

BEHAVIORAL

Cognitive therapy

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

BEHAVIORAL

Sleep principles discussion

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

Sponsors & Collaborators

  • Jun Wei

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2026-11-01
Completion
2026-11-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06687044 on ClinicalTrials.gov