Vitamin D and Sleep Disorders in Pregnancy

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04918368
• Other study ID #: GaziosmanpasaTREHc
• Status: Completed
• Start date: August 20, 2017
• Est. completion date: March 15, 2019

Study information

• Verified date: April 2018
• Source: Gaziosmanpasa Research and Education Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: March 15, 2019
• Est. primary completion date: December 25, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• singletone pregnant women
• second and third trimester pregnant women

Exclusion Criteria:

• psychiatric disorder
• sleep disorder

Related Conditions & MeSH terms

• Disease
• Parasomnias
• Pregnancy Related
• Sleep Disorder
• Sleep Wake Disorders
• Vitamin D Deficiency

Intervention

Behavioral:
• Behavioral scales were used
Women's Health Initiative Sleeplessness Scale (WHISS) and State Anxiety Scale (SAS), were applied.

Locations

Country	Name	City	State
Turkey	Fatma Ketenci Gencer	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Gaziosmanpasa Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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