Vitamin D and Sleep Disorders in Pregnancy

Completed

• Conditions: Pregnancy Related; Vitamin D Deficiency; Sleep Disorder
• Interventions: Behavioral: Behavioral scales were used

• Registration Number: NCT04918368
• Lead Sponsor: Gaziosmanpasa Research and Education Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-20
• Status Verified: 2018-04
• Primary Completion: 2018-12-25
• Study Completion: 2019-03-15
• Study First Submitted: 2021-04-17
• Study First Submitted QC: 2021-06-05
• Study First Posted: 2021-06-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 225

Inclusion Criteria

• singletone pregnant women
• second and third trimester pregnant women

Exclusion Criteria

• psychiatric disorder
• sleep disorder

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant women between 18-45 years old, being in second and third trimester of a singleton pregnancy	Behavioral scales were used	-

Primary Outcome Measures

Name	Time	Method
Health Initiative Sleeplessness Scale (WHISS)	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.
State Anxiety Scale (SAS)	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.

Trial Locations

Locations (1)

Fatma Ketenci Gencer; 🇹🇷 Istanbul, Turkey