Examining The Effect of Chronotype Differences on Sleep Quality and Pregnancy Symptoms in Pregnant Women

Pregnancy Complications Clinical Trial

Official title:

Examining The Effect of Chronotype Differences on Sleep Quality and Pregnancy Symptoms in Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06413784
• Other study ID #: 10840098-772.02-6181
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: May 2024
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: December 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy Complications

Intervention

Other:
• Morning chronotype
Sleep quality, gestational diabetes and pregnancy symptoms of morning chronotype individuals were examined.
• Intermediate chronotype
Sleep quality, gestational diabetes and pregnancy symptoms of intermediate chronotype individuals were examined.
• Evening chronotype
Sleep quality, gestational diabetes and pregnancy symptoms of evening chronotype individuals were examined.

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Morningness-Eveningness Questionnaire (MEQ)	It was used to measure the preference for a certain chronotype. This validated questionnaire evaluates individual differences in the degree to which respondents are aware and active at different times of the day. It has 19 items on sleep patterns and exhaustion. The responses to the scale items indicate preferences for waking and sleeping hours as well as the subjective "peak" times when respondents feel most refreshed. People were categorized as morningness chronotype (>65), intermediate chronotype (53-64), or eveningness chronotype (score of <52). The reliability of MEQ was 0.77 and the test alpha was equal to 0.78 (20).	5 minutes
Primary	The Pregnancy-Unique Quantification of Emesis and Nausea (PUQE)	The PUQE is a scoring system for nausea and vomiting during pregnancy, which consists of three items. The original PUQE entailed rating the daily number of vomiting episodes, the length of nausea in hours per day, and the number of retching episodes per 12 hours. Its validation was confirmed by Koren et al. a total score of 3-6 is considered mild nausea and vomiting, a total score of 7-12 is considered moderate nausea and vomiting, and a total score of 13-15 is considered severe nausea and vomiting	5 minutes
Primary	Oral Glucose Tolerance Testing (OGTT)	Pregnant women undergo a 75 g OGTT test between 24 and 28 weeks of . A plasma fasting blood glucose>126 mg/dL in a pregnant woman is considered overt diabetes (after confirmation) even if there is no prior history of diabetes. The OGTT test involves measurement of plasma glucose levels after an overnight fast (8 h), followed by oral consumption of 75 g glucose, and plasma glucose measurement at one and two hours. Gestational diabetes was defined as a fasting plasma glucose value>92 mg/dL or a one-hour plasma glucose value>180 mg/dL or a two-hour plasma glucose value>153 mg/dl.	15 minutes
Primary	The Pittsburgh Sleep Quality Index	It is evaluation of the sleep quality. There are 24 questions in all, 18 of which are used to determine the score. Subjective sleep quality, sleep latency, duration, habitual sleep efficiency, sleep disruptions, usage of sleeping pills, and dysfunction throughout the day are its seven constituent parts. The PSQI score is determined by assigning a point value between 0 and 3. A cumulative score of more than five indicates that the quality of sleep was inadequate. The score goes from 0 to 21.	10 minutes

External Links

•   Sleep duration and chronotype of pregnant women in the United States: An online cross-sectional survey study.