Vitamin D and Sleep Disorders in Pregnancy

NCT04918368 | Completed DMC

• 1 other identifier: GaziosmanpasaTREHc
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Disorder; Pregnancy Related; Vitamin D Deficiency

Keywords

anxiety; Pregnancy,; Sleep Wake Disorders; Vitamin D

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Pregnant women between 18-45 years old, being in second and third trimester of a singleton pregnancy

Behavioral: Behavioral scales were used

Interventions

Behavioral scales were used BEHAVIORAL

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

Pregnant women between 18-45 years old, being in second and third trimester of a singleton pregnancy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

225 pregnant women who are in second or third trimester of pregnancy

You may qualify if:

• singletone pregnant women
• second and third trimester pregnant women

You may not qualify if:

• psychiatric disorder
• sleep disorder

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Fatma Ketenci Gencer

Istanbul, 34255, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Vitamin D Deficiency; Anxiety Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 17, 2021
• First Posted: June 8, 2021
• Study Start: August 20, 2017
• Primary Completion: December 25, 2018
• Study Completion: March 15, 2019
• Last Updated: August 25, 2021

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)