NCT04918368|CompletedDMC
Vitamin D and Sleep Disorders in Pregnancy
Do Low Vitramin D Levels Increase the Frequency of Sleep Disorders and Anxiety in the 2nd and 3rd Trimester?
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Do Low Vitramin D Levels Increase the Frequency of Sleep Disorders and Anxiety in the 2nd and 3rd Trimester?
Sponsor study identifier
observational
225
1 country
1
Study Start
August 20, 2017
Actual (reported)Primary Completion
December 25, 2018
Actual (reported)Study Completion
March 15, 2019
Actual (reported)Lack of sleep and poor sleep quality in pregnant women are associated with maternal depression and cognitive-sensual irregularities. These irregularities were reported worsening women's life quality and even increasing suicide ideation. It is also associated with obstetrical complications such as fetal growth deficiency, preterm birth, prolonged labor, preeclampsia and increased abdominal delivery frequency.Vitamin D also may affect the sleep indirectly through the cases with nonspecific pains. It was reported that vitamin D levels are correlated with sleep disorders such as obstructive sleep apnea and restless legs syndrome. The primary purpose of this study is to examine sleep disorders and vitamin D levels in pregnant women, and also, secondarily, vitamin D - anxiety and sleep disorders - anxiety relations were assessed.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 15, 2019
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 20, 2017
Actual (reported)December 25, 2018
Actual (reported)March 15, 2019
Actual (reported)April 17, 2021
Actual (reported)June 8, 2021
Actual (reported)Health Initiative Sleeplessness Scale (WHISS)
Women's Health Initiative Sleeplessness Scale (WHISS) was used to assess the sleep status of pregnant women. In this scale consisting of five questions, first four questions focus on the period of time when sleeplessness started, status of not being able to continue the sleep and waking up early in the morning, while the last one focusses to determine the sleep quality. Scores of the scale range between 0 - 20. A score equal and above 10 means a sleeplessness problem. An increase in score means intensifying the sleeplessness symptoms.
Through study completion, an average of 1 year
State Anxiety Scale (SAS)
In anxiety screening of pregnant women, State Anxiety Scale (SAS) was used. Scores of the scale including twenty questions range between min. 20 and max. 80. Higher scores mean higher anxiety.
Through study completion, an average of 1 year
Women's Health Initiative Sleeplessness Scale (WHISS) and State Anxiety Scale (SAS), were applied.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
225 pregnant women who are in second or third trimester of pregnancy
Fatma Ketenci Gencer
Istanbul, 34255, Turkey (Türkiye)
225 participants (actual enrollment reported by the registry).
First Submitted
April 17, 2021
First Posted
June 8, 2021
Study Start
August 20, 2017
Actual (reported)The Effect of Compression Stockings on the Complaints of Pregnant Women With Restless Leg Syndrome
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Primary Completion
December 25, 2018
Actual (reported)Study Completion
March 15, 2019
Actual (reported)Last Updated
August 25, 2021
Record last verified: 2018-04
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Source: ClinicalTrials.gov.
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