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Sleep Disturbance in Pregnant Women in Upper Egypt

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03899727
Recruitment Status : Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Abbas, Assiut University

Brief Summary:
Pregnant women are associated with hormonal, anatomic and mechanical changes that Change sleep patterns and quality of sleep. Several Investigators have reported Associations between sleep disturbances and hypertension, Coronary artery disease, Diabetes, and depression. Most of these associations have been established in the association with sleep disturbances

Condition or disease Intervention/treatment
Sleep Disturbance Device: Polysomnography

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Sleep Disturbance in Pregnant Women in Upper Egypt
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders

Group/Cohort Intervention/treatment
Pregnant group
pregnant women in the third trimester of pregnancy
Device: Polysomnography
Polysomnography, also called a sleep study, is a test used to diagnose sleep disorders. Polysomnography records your brain waves, the oxygen level in your blood, heart rate and breathing, as well as eye and leg movements during the study

Non-pregnant group
middle aged women
Device: Polysomnography
Polysomnography, also called a sleep study, is a test used to diagnose sleep disorders. Polysomnography records your brain waves, the oxygen level in your blood, heart rate and breathing, as well as eye and leg movements during the study




Primary Outcome Measures :
  1. The percentage of women with sleep disturbances among overall included women [ Time Frame: 30 minutes ]
    diagnosis of sleep disturbances will depend on STOP and STOP-Bang questionnaires



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients visiting out patient clinic at Women Health Hospital will be counseled to participate in our study careful history taking and examination to exclude patients who not eligible to participate in the study.
Criteria

Inclusion Criteria:

  • All viable third trimester pregnancy

Exclusion Criteria:

  • Intrauterine fetal death
  • Any History of neurological, mental disorder.
  • Any previous diagnosed sleep disturbances breathing disorder before pregnancy.
  • Any patient with respiratory infection in the pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899727


Contacts
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Contact: Omar Shaaban, MD 010610020250 omshaaban2001@yahoo.com
Contact: Ali Yosef, MD 01005602284 aliharoun84@yahoo.com

Sponsors and Collaborators
Assiut University

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Responsible Party: Ahmed Mohamed Abbas, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03899727     History of Changes
Other Study ID Numbers: SDUE
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Dyssomnias
Sleep Wake Disorders
Parasomnias
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms