NCT03763071|Completed
Sleep Disturbances in the 2nd and 3rd Trimester
Sleep Patterns and Disturbances in the Second and Third Trimester of Uncomplicated Pregnancy
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Sleep Patterns and Disturbances in the Second and Third Trimester of Uncomplicated Pregnancy
Sponsor study identifier
observational
683
1 country
1
Study Start
December 7, 2018
Actual (reported)Primary Completion
April 8, 2020
Actual (reported)Study Completion
April 29, 2020
Actual (reported)Sleep disorders and disturbances are mostly underestimated in clinical practice. Moreover, this problem is generally neglected by the pregnant themselves. Today, it is important to underline any problem that may have an affect to improve the quality of life during pregnancy. This study assesses the sleep quality, insomnia patterns and obstructive sleep apnea in the second and third trimesters of pregnancy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 29, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 23, 2018
Actual (reported)December 4, 2018
Actual (reported)December 7, 2018
Actual (reported)April 8, 2020
Actual (reported)April 29, 2020
Actual (reported)Pittsburgh Sleep Quality Index (PSQI)
The order of the PSQI items has been modified from the original order in order to fit the first 9 items (which are the only items that contribute to the total score) on a single page. Item 10, which is the second page of the scale, does not contribute to the PSQI score. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Through study completion, an average of 39 weeks
Berlin Questionnaire
The questionnaire consists of 3 categories related to the risk of having sleep apnea. Patients can be classified into High Risk or Low Risk based on their responses to the individual items and their overall scores in the symptom categories. High Risk: if there are 2 or more categories where the score is positive. Low Risk: if there is only 1 or no categories where the score is positive.
Through study completion, an average of 39 weeks
Pregnant women in the 2nd or 3th trimester Patient-reported scales to measure sleep disorders
Patient-reported scales to measure sleep disorders include below mentioned scales: Pittsburgh Sleep Quality Index; measures the quality of sleep Berlin Questionnaire; measures the obstructive sleep apnea Stop-Bang questionnaire; measures the obstructive sleep apnea Insomnia Severity Index; measures the insomnia and related parameters
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Volunteered, low-risk, uncomplicated singleton pregnancy
Bartin State Hospital
Bartın, Turkey (Türkiye)
Murat Yassa, MD
Bartin State Hospital
683 participants (actual enrollment reported by the registry).
First Submitted
November 23, 2018
First Posted
December 4, 2018
Study Start
December 7, 2018
Actual (reported)Sleep in Late Pregnancy - Artificial Intelligence Development for the Detection of Disturbances and Disorders
The Effects of Pregnancy Classes and Contributing Factors to Postpartum Depression
Stop-Bang questionnaire
This questionnaire evaluates the risk of sleep apnea. Low risk of OSA: Yes to 0-2 questions Intermediate risk of OSA: Yes to 3-4 questions High risk of OSA: Yes to 5-8 questions or Yes to 2 or more of 4 STOP questions + male gender or Yes to 2 or more of 4 STOP questions + BMI \> 35 kg/m2 or Yes to 2 or more of 4 STOP questions + neck circumference.
Through study completion, an average of 39 weeks
Insomnia Severity Index (ISI)
ISI measures the insomnia and related parameters. Scoring and Interpretation as follows: Add the scores for all seven items (questions 1 + 2 + 3 + 4 + 5 +6 + 7) will give the total score. Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
Through study completion, an average of 39 weeks
Contact the study team to confirm eligibility.
Primary Completion
April 8, 2020
Actual (reported)Study Completion
April 29, 2020
Actual (reported)Last Updated
January 26, 2021
Record last verified: 2021-01
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Source: ClinicalTrials.gov.
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