Clinical trial NCT06413784: Examining The Effect of Chronotype Differences on Sleep Quality and Pregnancy Symptoms in Pregnant Women
Official title: Examining The Effect of Chronotype Differences on Sleep Quality and Pregnancy Symptoms in Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronotype
Pregnancy Complications
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-05-14
Enrollment: 85
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a single-blind (participants), parallel trial
Primary purpose: OTHER

Brief summary: Purpose: The aim of this study was to examine the effect of chronotype differences on sleep quality and pregnancy symptoms in pregnant women.

Methods: Eighty-five pregnant women in the second trimester were included in the study. The chronotypes of pregnant women were determined using the Morningness-Eveningness Questionnaire (MEQ). Then, Oral Glucose Tolerance tests were performed on the participants between 24-28 weeks. Also, pregnant women's nausea and vomiting conditions with the Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) and sleep quality with Pittsburgh Sleep Quality Index (PSQI) were evaluated.

Detailed description: Purpose: The aim of this study was to examine the effect of chronotype differences on sleep quality and pregnancy symptoms in pregnant women.

Methods: This study is a single-blind (participants), parallel trial. It was performed in line with the principles of the Declaration of Helsinki. The followings were the study's inclusion requirements: being between the ages of 18-40, having a singleton pregnancy, being in the second trimester, and not having any known chronic disease. Exclusion criteria are working night shifts, having a high-risk pregnancy, and having a neurological or orthopedic disease. Eighty-five pregnant women in the second trimester were included in the study. The chronotypes of pregnant women were determined using the Morningness-Eveningness Questionnaire (MEQ). Then, Oral Glucose Tolerance tests were performed on the participants between 24-28 weeks. Also, pregnant women's nausea and vomiting conditions with the Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) and sleep quality with Pittsburgh Sleep Quality Index (PSQI) were evaluated.

Eligibility criteria: Inclusion Criteria:

* being between the ages of 18-40,
* having a singleton pregnancy, being in the second trimester,
* not having any known chronic disease.

Exclusion Criteria:

* working night shifts,
* having a high-risk pregnancy,
* having a neurological or orthopedic disease.

Primary outcomes:
measure: The Morningness-Eveningness Questionnaire (MEQ)
timeFrame: 5 minutes
measure: The Pregnancy-Unique Quantification of Emesis and Nausea (PUQE)
timeFrame: 5 minutes
measure: Oral Glucose Tolerance Testing (OGTT)
timeFrame: 15 minutes
measure: The Pittsburgh Sleep Quality Index
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
affiliation: Medipol University
name: MERVE YILMAZ MENEK, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cassidy EM, Bailey CP, Napolitano MA, Vyas AN. Sleep duration and chronotype of pregnant women in the United States: An online cross-sectional survey study. Prev Med Rep. 2022 Dec 6;31:102088. doi: 10.1016/j.pmedr.2022.102088. eCollection 2023 Feb.