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Completed

NCT Number: NCT04918368

Vitamin D and Sleep Disorders in Pregnancy

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.

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Key information

Conditions

Sleep Disorder Anxiety Disorders Avitaminosis Deficiency Diseases Malnutrition Mental Disorders Nervous System Diseases Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Pregnancy Related Signs and Symptoms Sleep Wake Disorders Vitamin D Deficiency

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Fatma Ketenci Gencer

Istanbul, 34255, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • singletone pregnant women
  • second and third trimester pregnant women

Exclusion criteria

  • psychiatric disorder
  • sleep disorder

Treatment and study plan

Behavioral scales were used

Behavioral

Women's Health Initiative Sleeplessness Scale (WHISS) and State Anxiety Scale (SAS), were applied.

Primary outcomes

  1. Health Initiative Sleeplessness Scale (WHISS)

    Time frame: Through study completion, an average of 1 year

    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.

  2. State Anxiety Scale (SAS)

    Time frame: Through study completion, an average of 1 year

    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.

Sponsors and collaborators

Lead sponsor

Gaziosmanpasa Research and Education Hospital

Other Gov

Registry information

Official study title

Do Low Vitramin D Levels Increase the Frequency of Sleep Disorders and Anxiety in the 2nd and 3rd Trimester?

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jun 8, 2021
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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