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

J

Jun Wei

Status

Invitation-only

Conditions

Gestational Diabetes
NICU Infants
Hypertension in Pregnancy
Preterm Labor

Treatments

Behavioral: Sleep principles discussion
Behavioral: Stimulation control
Behavioral: Sleep restriction
Behavioral: Cognitive therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06687044
Sleep improvement therapy

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

300 participants in 2 patient groups, including a placebo group

Sleep improvement Therapy group(CBT-I)
Experimental group
Treatment:
Behavioral: Cognitive therapy
Behavioral: Stimulation control
Behavioral: Sleep restriction
Control group (TAU)
Placebo Comparator group
Treatment:
Behavioral: Sleep principles discussion

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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