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

Effect of Insomnia and Sleep Deprivation in 3rdtrimester Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04612361
• Other study ID #: Cairo University
• Status: Not yet recruiting
• Start date: October 30, 2020
• Est. completion date: April 5, 2021

Study information

• Verified date: October 2020
• Source: Dr. Osman Hospital
• Contact: Yomna Bayoumi, M.D
• Phone: +201066812955
• Email: yoyobayo27[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 750
• Est. completion date: April 5, 2021
• Est. primary completion date: March 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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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Related Conditions & MeSH terms

• Effect of Insomnia and Sleep Deprivation in 3rdtrimester
• Sleep Deprivation
• Sleep Initiation and Maintenance Disorders

Intervention

Other:
• insommnia severity index questionnaire
insomnia severity index questionnaire and scoring system

Locations

Country	Name	City	State
Egypt	Cairo university Hospitals,Obstetric clinic	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Osman Hospital	Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Secondary	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	6 months