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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Complications; Chronotype
• Intervention / Treatment: Other: Morning chronotype; Other: Intermediate chronotype; Other: Evening chronotype

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.

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • İstanbul Medipol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Morning Chronotype; Sleep quality, gestational diabetes and pregnancy symptoms of morning chronotype individuals were examined.	Other: Morning chronotype; Sleep quality, gestational diabetes and pregnancy symptoms of morning chronotype individuals were examined.
Experimental: Intermediate chronotype; Sleep quality, gestational diabetes and pregnancy symptoms of Intermediate chronotype individuals were examined.	Other: Intermediate chronotype; Sleep quality, gestational diabetes and pregnancy symptoms of intermediate chronotype individuals were examined.
Experimental: Evening chronotype; Sleep quality, gestational diabetes and pregnancy symptoms of evening chronotype individuals were examined.	Other: Evening chronotype; Sleep quality, gestational diabetes and pregnancy symptoms of evening chronotype individuals were examined.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 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

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Investigators: Principal Investigator: Merve Yilmaz Menek, PhD, Medipol University

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: May 9, 2024
• First Submitted That Met QC Criteria: May 9, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications
• Other Study ID Numbers: 10840098-772.02-6181

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no a plan to make individual participant data (IPD)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No