Clinical trial NCT05765149: A Cohort Study on Sleep Disorders During Pregnancy
Official title: Sleep Trajectories Among Pregnant Women and Its Impact on Maternal and Infant Outcomes: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Disorder
Lead sponsor: Women's Hospital School Of Medicine Zhejiang University
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is mainly from maternal hospitals.

Brief summary: The goal of this observational study is to: 1) determine the prevalence of sleep disorders in pregnancy and the early postpartum; 2) identify factors associated with sleep disturbance during pregnancy and the early postpartum; 3) describe the progression of sleep quality and quantity as gestational age; 4) determine if sleep is associated with adverse perinatal outcomes. Participants were asked to wear a forehead sleep recorder for 4 consecutive days and to complete a sleep questionnaire at ten timepoints: at 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, and 9 months pregnant and at 1 month, 2 months and 3 months postpartum.

Detailed description: There is a high incidence of sleep disturbances globally, especially among pregnant women. Long-term sleep disorders seriously affect the quality life of individuals, and it becomes undoubtedly an important public health problem. Studies have shown that sleep disorders during pregnancy can have short-term and long-term adverse effects on both mothers and their babies. In addition, sleep during pregnancy exhibits different characteristics at different stages. Most of the existing studies are based on the overall development trend to study sleep characteristics, ignoring potential individual differences. Based on the concept of precision medicine, this study intends to establish a cohort focusing on the sleep health of pregnant women, and carry out continuous home sleep monitoring of pregnant women from both subjective and objective perspectives. The aim of this study is, firstly, to explore the longitudinal change characteristics, potential classification and influencing factors of sleep during pregnancy; secondly, to analyze the differences in maternal and infant adverse outcomes among pregnant women with different sleep development trajectories. The final goal is to reveal the exposure window of maternal and infant adverse outcomes caused by sleep, thus improving the accuracy of outcome prediction, and promoting the development of accurate and personalized sleep management programs.

Eligibility criteria: Inclusion Criteria:

1. Gestation age ≤ 13 weeks + 6 days
2. 20 years old ≤ Age ≤ 40 years old
3. Singleton pregnancy
4. Give informed consent and able to participated

Exclusion Criteria:

1. Unmarried, divorced or widowed
2. Women who suffered severe physical or mental illness
3. Women who suffered death, abortion, stillbirth or neonatal death during the study
4. Women who are participating in other studies
5. Other reasons

Primary outcomes:
measure: Preterm birth
timeFrame: delivery
measure: Caesarean section
timeFrame: delivery
measure: Postpartum depression symptoms at 1 month after delivery
timeFrame: 1 month after delivery
measure: Postpartum depression symptoms at 2 months after delivery
timeFrame: 2 months after delivery
measure: Postpartum depression symptoms at 3 months after delivery
timeFrame: 3 months after delivery
Secondary outcomes:
measure: 1-minute Apgar score
timeFrame: 1 minute after delivey
measure: 5-minute Apgar score
timeFrame: 5 minutes after delivey
measure: Infant's length
timeFrame: delivey
measure: Infant's weight
timeFrame: delivey
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Women's Hospital School of Medicine Zhejiang University
state: Zhejiang
Study officials:
affiliation: Women's Hospital School Of Medicine Zhejiang University
name: Man Wang, Master
role: PRINCIPAL_INVESTIGATOR
References: