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

NCT06413784 | Completed

• 1 other identifier: 10840098-772.02-6181
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronotype; Pregnancy Complications

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

Study Arms (3)

Morning Chronotype

EXPERIMENTAL

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

Other: Morning chronotype

Intermediate chronotype

EXPERIMENTAL

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

Other: Intermediate chronotype

Evening chronotype

EXPERIMENTAL

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

Other: Evening chronotype

Interventions

Morning chronotype OTHER

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

Morning Chronotype

Intermediate chronotype OTHER

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

Intermediate chronotype

Evening chronotype OTHER

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

Evening chronotype

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

Related 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.

  PMID: 36820370 RESULT

Related Links

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

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• MERVE YILMAZ MENEK, PhD

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were blind
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study is a single-blind (participants), parallel trial

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 14, 2024
• Study Start: April 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: February 1, 2023
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)