Sleep DisorderNCT05765149
A Cohort Study on Sleep Disorders During Pregnancy
An observational study of Sleep Disorder, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 17 Feb 2023to Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study population is mainly from maternal hospitals.
Who may be able to join
- Gestation age ≤ 13 weeks + 6 days
- 20 years old ≤ Age ≤ 40 years old
- Singleton pregnancy
- Give informed consent and able to participated
Who cannot join
- Unmarried, divorced or widowed
- Women who suffered severe physical or mental illness
- Women who suffered death, abortion, stillbirth or neonatal death during the study
- Women who are participating in other studies
- Other reasons
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, 310029
Man Wang, +86 15068826022, wmdouble@163.com
About this study
Official title: Sleep Trajectories Among Pregnant Women and Its Impact on Maternal and Infant Outcomes: a Prospective Cohort Study
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.
Read the 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.
- Conditions
- Sleep Disorder
- Being tested
- No intervention
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study, no intervention will be implemented.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Cohort | This is an observational study. We plan to recruit 1000 pregnant women during 10-13 weeks gestational age to build a sleep cohort. Their sleep changes during pregnancy will be recorded for identifying similar groups. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm birth
Preterm birth refers to a body born before 37 weeks of gestation. It will be identified according to the medical history records.
Measured: delivery
Caesarean section
Caesarean section refers to a baby delivered through an incision in the mother's abdomen. It will be identified according to the medical history records.
Measured: delivery
Postpartum depression symptoms at 1 month after delivery
Postpartum depression symptoms at 1 month after delivery will be measured by the Edinburgh postpartum depression scale (EPDS).
Measured: 1 month after delivery
Postpartum depression symptoms at 2 months after delivery
Postpartum depression symptoms at 2 months after delivery will be measured by the Edinburgh postpartum depression scale (EPDS).
Measured: 2 months after delivery
Postpartum depression symptoms at 3 months after delivery
Postpartum depression symptoms at 3 months after delivery will be measured by the Edinburgh postpartum depression scale (EPDS).
Measured: 3 months after delivery
Secondary outcomes (4)
1-minute Apgar score
Apgar is a quick test performed on a baby at 1 and 5 minutes after birth. It will be identified according to the medical history records.
Measured: 1 minute after delivey
5-minute Apgar score
Apgar is a quick test performed on a baby at 1 and 5 minutes after birth. It will be identified according to the medical history records.
Measured: 5 minutes after delivey
Infant's length
It will be identified according to the medical history records.
Measured: delivey
Infant's weight
It will be identified according to the medical history records.
Measured: delivey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start17 Feb 2023
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Man Wang, Master, Principal investigator, Women's Hospital School Of Medicine Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765149
- Sponsor's protocol ID
- IRB-20220305-R
- Status last verified
- Feb 2023
- First submitted
- 2 Feb 2023
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Trajectories Among Pregnant Women and Its Impact on Maternal and Infant Outcomes: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05765149
- Acronym / sponsor ID
- IRB-20220305-R
- Conditions
- Sleep Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep Cohort | – | Other: No interventionThis is an observational study. We plan to recruit 1000 pregnant women during 10-13 weeks gestational age to build a sleep cohort. Their sleep changes during pregnancy will be recorded for identifying similar groups. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population is mainly from maternal hospitals.
Key inclusion criteria (4 listed)
- Gestation age ≤ 13 weeks + 6 days
- 20 years old ≤ Age ≤ 40 years old
- Singleton pregnancy
- Give informed consent and able to participated
Key exclusion criteria (5 listed)
- Unmarried, divorced or widowed
- Women who suffered severe physical or mental illness
- Women who suffered death, abortion, stillbirth or neonatal death during the study
- Women who are participating in other studies
- Other reasons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is an observational study, no intervention will be implemented. | Other | Sleep Cohort |
Primary outcome
Preterm birth
Time frame: delivery
Preterm birth refers to a body born before 37 weeks of gestation. It will be identified according to the medical history records.
Caesarean section
Time frame: delivery
Caesarean section refers to a baby delivered through an incision in the mother's abdomen. It will be identified according to the medical history records.
Postpartum depression symptoms at 1 month after delivery
Time frame: 1 month after delivery
Postpartum depression symptoms at 1 month after delivery will be measured by the Edinburgh postpartum depression scale (EPDS).
Postpartum depression symptoms at 2 months after delivery
Time frame: 2 months after delivery
Postpartum depression symptoms at 2 months after delivery will be measured by the Edinburgh postpartum depression scale (EPDS).
Postpartum depression symptoms at 3 months after delivery
Time frame: 3 months after delivery
Postpartum depression symptoms at 3 months after delivery will be measured by the Edinburgh postpartum depression scale (EPDS).
4 secondary outcomes
1-minute Apgar score
Time frame: 1 minute after delivey
5-minute Apgar score
Time frame: 5 minutes after delivey
Infant's length
Time frame: delivey
Infant's weight
Time frame: delivey
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Man Wang, Master principal investigator
Women's Hospital School Of Medicine Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disorder, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyan Yu, Master (+86 13575737900, yuxy@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preterm birth (time frame: delivery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.