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Effect of Clinical Insomnia and Sleep Deprivation on Maternal-fetal Outcome Among Egyptian Females in 3rd Trimester

NCT ID: NCT04612361

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-30

Study Completion Date

2021-04-05

Brief Summary

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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

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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.

Conditions

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Effect of Insomnia and Sleep Deprivation in 3rdtrimester

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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non impaired sleep group

about 200-250 patients

insommnia severity index questionnaire

Intervention Type OTHER

insomnia severity index questionnaire and scoring system

insomnia group

about 200 patients

insommnia severity index questionnaire

Intervention Type OTHER

insomnia severity index questionnaire and scoring system

sleep deprived group

about 200-250 patients

insommnia severity index questionnaire

Intervention Type OTHER

insomnia severity index questionnaire and scoring system

Interventions

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insommnia severity index questionnaire

insomnia severity index questionnaire and scoring system

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role collaborator

Dr. Osman Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr Hisham Gouda

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo university Hospitals,Obstetric clinic

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Yomna Bayoumi, M.D

Role: CONTACT

[email protected]
+201066812955

Rana M Abdella, M.D

Role: CONTACT

[email protected]
01010580614

Facility Contacts

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Yomna Bayoumi, M.D

Role: primary

[email protected]
+201066812955

Other Identifiers

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Cairo University

Identifier Type: -

Identifier Source: org_study_id