## Protocol Section
### Identification Module
**NCT ID:** NCT06413784

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 10840098-772.02-6181
#### Organization
**Class:** OTHER
**Full Name:** Istanbul Medipol University Hospital
### Status Module
#### Completion Date
**Date:** 2022-12-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-09

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-09-01

**Type:** ACTUAL

#### Start Date
**Date:** 2022-04-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Istanbul Medipol University Hospital

#### Responsible Party

**Investigator Affiliation:** Istanbul Medipol University Hospital

**Investigator Full Name:** merve yilmaz menek

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Chronotype

- Pregnancy Complications

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** This study is a single-blind (participants), parallel trial

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Participants were blind

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 85

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: Morning chronotype

**Label:** Morning Chronotype

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Other: Intermediate chronotype

**Label:** Intermediate chronotype

**Type:** EXPERIMENTAL

#### Arm Group 3

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

**Intervention Names:**

- Other: Evening chronotype

**Label:** Evening chronotype

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Morning Chronotype

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

**Name:** Morning chronotype

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Intermediate chronotype

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

**Name:** Intermediate chronotype

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Evening chronotype

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

**Name:** Evening chronotype

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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).

**Measure:** The Morningness-Eveningness Questionnaire (MEQ)

**Time Frame:** 5 minutes

**Description:** 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

**Measure:** The Pregnancy-Unique Quantification of Emesis and Nausea (PUQE)

**Time Frame:** 5 minutes

**Description:** 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.

**Measure:** Oral Glucose Tolerance Testing (OGTT)

**Time Frame:** 15 minutes

**Description:** 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.

**Measure:** The Pittsburgh Sleep Quality Index

**Time Frame:** 10 minutes

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Maximum Age:** 40 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Istanbul

**Country:** Turkey

**Facility:** Istanbul Medipol University

#### Overall Officials

**Official 1:**

**Affiliation:** Medipol University

**Name:** MERVE YILMAZ MENEK, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** There is no a plan to make individual participant data (IPD)

**IPD Sharing:** NO

### References Module

#### 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.

**PMID:** 36820370

#### See Also Links

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

**URL:** https://pubmed.ncbi.nlm.nih.gov/36820370/

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14127

- Name: Pregnancy Complications

- Relevance: HIGH

- As Found: Pregnancy Complications

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011248

- Term: Pregnancy Complications

### Misc Info Module

- Version Holder: 2024-05-31
