Effect of Insomnia and Sleep Deprivation in 3rdtrimesterNCT04612361
Effect of Clinical Insomnia and Sleep Deprivation on Maternal-fetal Outcome Among Egyptian Females in 3rd Trimester
An observational study of Effect of Insomnia and Sleep Deprivation in 3rdtrimester, run by Dr. Osman Hospital at 1 site in Egypt.
Trial summary
This prospective observational study aims at investigating whether insomnia or sleep deprivation during the 3rd trimester of pregnancy can be implicated in the occurrence of adverse maternal or fetal outcome. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Effect of Insomnia and Sleep Deprivation in 3rdtrimester
- What is being tested?
- insommnia severity index questionnaire
- How many people
- 750 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Oct 2020to 5 Apr 2021
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: * 28 weeks gestational age as confirmed by first trimester scan or reliable 1st day of LMP ,normal singleton pregnancy , literate with no history of previous preterm birth or Cesarean delivery. , with special emphasis on: history of impaired sleep due to insomnia or sleep deprivation due to working on night shifts, history of insomnia during first 20 weeks of pregnancy.Number of night sleep hours and total number of sleep hours during the day
Inclusion Criteria:The inclusion criteria will be ≥ 28 weeks gestational age as confirmed by first trimester scan or reliable 1st day of LMP ,normal singleton pregnancy , literate with no history of previous preterm birth or Cesarean delivery.
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Exclusion Criteria Women with history of medical disorders with pregnancy, BMI≥ 30 , placenta previa, recent urinary tract or vaginal infections or obstetric complications during the current pregnancy or risk factors for preterm labour will be excluded. Women with history of diagnosed psychiatric disorder will be also excluded
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Trial locations and contacts
1 site in 1 country.
Egypt1 site
Cairo university Hospitals,Obstetric clinic
Cairo
Yomna Bayoumi, M.D, +201066812955, yoyobayo27@gmail.com
Yomna Bayoumi, M.D
About this study
Official title: Can Clinical Insomnia and Sleep Deprivation be a Cause of Adverse Maternal-fetal Outcome Among Egyptian Females in Their Last Trimester of Pregnancy;a Prospective Cohort Study
This prospective observational study aims at investigating whether insomnia or sleep deprivation during the 3rd trimester of pregnancy can be implicated in the occurrence of adverse maternal or fetal outcome. Data will be collected from all participants with special emphasis on: history of impaired sleep due to insomnia or sleep deprivation due to working on night shifts, history of insomnia during first 20 weeks of pregnancy.Number of night sleep hours and total number of sleep hours during the day will be recorded for each participant. The Insomnia severity index(ISI) a brief self report questionnaire used for assessing the degree of current insomnia will be administered to all participants at the time of their routine antenatal care visits to detect insomnia and its severity if present .The possible relationship between clinical insomnia or sleep deprivation and the occurrence of preterm birth or IUGR will be explored and the association with increased Cesarean delivery rate or painful and/ or prolonged labour.
Read the detailed description
The demographic data will be collected from all participants including patient's age , BMI , gestational age, personal,present and past obstetric history, with special emphasis on: history of impaired sleep due to insomnia or sleep deprivation due to working on night shifts, history of insomnia during first 20 weeks of pregnancy.Number of night sleep hours and total number of sleep hours during the day will be recorded for each participant. The Insomnia severity index(ISI) a brief self report questionnaire used for assessing the degree of current insomnia will be administered to all participants at the time of their routine antenatal care visits to detect insomnia and its severity if present .It will be applied both in English and in its Arabic translated version. The ISI comprises seven items assessing the type of insomnia problem, satisfaction with the current sleep pattern, affection of the quality of life by the sleep problem, the degree of distress related to insomnia and its affect on daily functioning .Each item is scored on a scale of 0-4 and the total ISI score ranges from 0-28, with higher scores indicating more severe insomnia. A written informed consent will be obtained from each participant before joining the study. The participants will be followed up throughout their 3rd trimester till the time of their delivery. Any drop-out cases will be reported. The pregnant women who didn't suffer insomnia in any of the assessments, nor were sleep deprived due to working on night shifts will comprise the the non impaired sleep group and those suffering clinical insomnia as detected by the insomnia severity index (total score > or equal to 15) in any or all of the assessments will comprise the insomnia group. The 3rd group (sleep deprived group) will be comprised of participants who are only sleep deprived due to working on night shifts and not due to insomnia. Those getting less than 7hours of sleep/day will be considered sleep deprived.
The patients will be assessed during their routine visits with transabdominal ultrasound and Doppler studies for evaluation of fetal growth ,fetal well being ,placenta and exclusion of congenital anomalies, abnormal fetal position or presentation .The gestational age at delivery,mode of delivery,presence of prolonged or painful labour and fetal birth weight will all be recorded for comparison.
- Being tested
- insommnia severity index questionnaire
- Keywords
- insomnia,sleep deprivation,adverse maternal,fetal outcome
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insommnia severity index questionnaireOther
insomnia severity index questionnaire and scoring system
| Study group | Role | What they receive |
|---|---|---|
| non impaired sleep group | about 200-250 patients Receives: Other: insommnia severity index questionnaire | |
| insomnia group | about 200 patients Receives: Other: insommnia severity index questionnaire | |
| sleep deprived group | about 200-250 patients Receives: Other: insommnia severity index questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore possible relationship between clinical insomnia or sleep deprivation and the occurrence of preterm birth or IUGR
number of preterm deliveries and number of IUGR among the studied groups
Measured: 6 months
Secondary outcomes (1)
to evaluate whether insomnia or sleep deprivation are associated with increased Cesarean delivery rate or painful labour.
Number of cesarean deliveries among the 3 studied groups
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start30 Oct 2020 (estimated)
- Primary completion28 Mar 2021 (estimated)
- Study completion5 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Insomnia and Sleep Deprivation in 3rdtrimesterStudies 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
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Osman Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Dr Hisham Gouda, Dr. Osman Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612361
- Sponsor's protocol ID
- Cairo University
- Status last verified
- Oct 2020
- First submitted
- 27 Oct 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Clinical Insomnia and Sleep Deprivation be a Cause of Adverse Maternal-fetal Outcome Among Egyptian Females in Their Last Trimester of Pregnancy;a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04612361
- Acronym / sponsor ID
- Cairo University
- Keywords
- insomnia,sleep deprivation,adverse maternal,fetal outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Dr. Osman HospitalUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 30 Oct 2020 (estimated)
- Primary completion
- 28 Mar 2021 (estimated)
- Study completion
- 5 Apr 2021 (estimated)
- First posted
- 3 Nov 2020 (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.
This prospective observational study aims at investigating whether insomnia or sleep deprivation during the 3rd trimester of pregnancy can be implicated in the occurrence of adverse maternal or fetal outcome. Data will be collected from all participants with special emphasis on: history of impaired sleep due to insomnia or sleep deprivation due to working on night shifts, history of insomnia during first 20 weeks of pregnancy.Number of night sleep hours and total number of sleep hours during the day will be recorded for each participant. The Insomnia severity index(ISI) a brief self report questionnaire used for assessing the degree of current insomnia will be administered to all participants at the time of their routine antenatal care visits to detect insomnia and its severity if present .The possible relationship between clinical insomnia or sleep deprivation and the occurrence of preterm birth or IUGR will be explored and the association with increased Cesarean delivery rate or painful and/ or prolonged labour.
Detailed description
The demographic data will be collected from all participants including patient's age , BMI , gestational age, personal,present and past obstetric history, with special emphasis on: history of impaired sleep due to insomnia or sleep deprivation due to working on night shifts, history of insomnia during first 20 weeks of pregnancy.Number of night sleep hours and total number of sleep hours during the day will be recorded for each participant. The Insomnia severity index(ISI) a brief self report questionnaire used for assessing the degree of current insomnia will be administered to all participants at the time of their routine antenatal care visits to detect insomnia and its severity if present .It will be applied both in English and in its Arabic translated version. The ISI comprises seven items assessing the type of insomnia problem, satisfaction with the current sleep pattern, affection of the quality of life by the sleep problem, the degree of distress related to insomnia and its affect on daily functioning .Each item is scored on a scale of 0-4 and the total ISI score ranges from 0-28, with higher scores indicating more severe insomnia. A written informed consent will be obtained from each participant before joining the study. The participants will be followed up throughout their 3rd trimester till the time of their delivery. Any drop-out cases will be reported. The pregnant women who didn't suffer insomnia in any of the assessments, nor were sleep deprived due to working on night shifts will comprise the the non impaired sleep group and those suffering clinical insomnia as detected by the insomnia severity index (total score > or equal to 15) in any or all of the assessments will comprise the insomnia group. The 3rd group (sleep deprived group) will be comprised of participants who are only sleep deprived due to working on night shifts and not due to insomnia. Those getting less than 7hours of sleep/day will be considered sleep deprived.
The patients will be assessed during their routine visits with transabdominal ultrasound and Doppler studies for evaluation of fetal growth ,fetal well being ,placenta and exclusion of congenital anomalies, abnormal fetal position or presentation .The gestational age at delivery,mode of delivery,presence of prolonged or painful labour and fetal birth weight will all be recorded for comparison.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| non impaired sleep group | – | Other: insommnia severity index questionnaireabout 200-250 patients |
| insomnia group | – | Other: insommnia severity index questionnaireabout 200 patients |
| sleep deprived group | – | Other: insommnia severity index questionnaireabout 200-250 patients |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * 28 weeks gestational age as confirmed by first trimester scan or reliable 1st day of LMP ,normal singleton pregnancy , literate with no history of previous preterm birth or Cesarean delivery. , with special emphasis on: history of impaired sleep due to insomnia or sleep deprivation due to working on night shifts, history of insomnia during first 20 weeks of pregnancy.Number of night sleep hours and total number of sleep hours during the day
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 |
|---|---|---|
| insommnia severity index questionnaireinsomnia severity index questionnaire and scoring system | Other | insomnia group, non impaired sleep group, sleep deprived group |
Primary outcome
To explore possible relationship between clinical insomnia or sleep deprivation and the occurrence of preterm birth or IUGR
Time frame: 6 months
number of preterm deliveries and number of IUGR among the studied groups
1 secondary outcome
to evaluate whether insomnia or sleep deprivation are associated with increased Cesarean delivery rate or painful labour.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Individual participant dataSharing planned: Undecided
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.
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 Effect of Insomnia and Sleep Deprivation in 3rdtrimester, run by Dr. Osman Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 3 Nov 2020. 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 Egypt. 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 Yomna Bayoumi, M.D (+201066812955, yoyobayo27@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To explore possible relationship between clinical insomnia or sleep deprivation and the occurrence of preterm birth or IUGR (time frame: 6 months). 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 3 Nov 2020; AzTrials last refreshed its copy on 8 Nov 2026.