Sleep Disturbance in Pregnant Women in Upper Egypt

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

Study Overview

• Status: Completed
• Conditions: Sleep Disturbance
• Intervention / Treatment: Device: Polysomnography

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Assiut, Cairo, Egypt, 002
      • Ahmed Abbas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of women with sleep disturbances among overall included women	diagnosis of sleep disturbances will depend on STOP and STOP-Bang questionnaires	30 minutes

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): January 15, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: April 1, 2019
• First Submitted That Met QC Criteria: April 1, 2019
• First Posted (Actual): April 2, 2019

Study Record Updates

• Last Update Posted (Actual): April 23, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: SDUE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No