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Completed

NCT Number: NCT06413784

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Morning chronotype

Other

Sleep quality, gestational diabetes and pregnancy symptoms of morning chronotype individuals were examined.

Intermediate chronotype

Other

Sleep quality, gestational diabetes and pregnancy symptoms of intermediate chronotype individuals were examined.

Evening chronotype

Other

Sleep quality, gestational diabetes and pregnancy symptoms of evening chronotype individuals were examined.

Primary outcomes

  1. The Morningness-Eveningness Questionnaire (MEQ)

    Time frame: 5 minutes

    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).

  2. The Pregnancy-Unique Quantification of Emesis and Nausea (PUQE)

    Time frame: 5 minutes

    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

  3. Oral Glucose Tolerance Testing (OGTT)

    Time frame: 15 minutes

    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.

  4. The Pittsburgh Sleep Quality Index

    Time frame: 10 minutes

    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.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
May 14, 2024
Registry last updated
Oct 3, 2024

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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