ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12618000176268

Ethics application status

Approved

Date submitted

26/09/2017

Date registered

5/02/2018

Date last updated

5/02/2018

Type of registration

Retrospectively registered

Titles & IDs

Public title

Assessment of obstructive sleep apnea syndrome prevalence in patients undergoing cesarean section using the STOP-BANG questionnaire

Scientific title

Assessment of obstructive sleep apnea syndrome prevalence in patients undergoing cesarean section using the STOP-BANG questionnaire

Secondary ID [1]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

obstructive sleep apnea syndrome

Condition category

Condition code

Respiratory

Sleep apnoea

Reproductive Health and Childbirth

Childbirth and postnatal care

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

In this prospective observational study, women undergoing cesarean section will recruite.
Demographic data including body weight, body mass index, neck circumference, blood pressure, and will collect. Screening evaluations for obstructive sleep apnea syndrome included Stop-Bang questionnaire, Preferred anesthesia methods is assessed review of medical records. Data is collected first hour before surgery.

Intervention code [1]

Not applicable

Comparator / control treatment

no control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

to investigate the frequency of obstructive sleep apnea with Stop-Bang questionnaire in obstetric patients for cesarean operation
The STOP-BANG questionnaire consists of snoring, tired, observed, blood pressure, body mass index, age, neck circumference, and gender.

Timepoint [1]

First hour before surgery

Secondary outcome [1]

to examine the preferred methods of anesthesia by review of medical records

Timepoint [1]

First hour post surgery

Eligibility

Key inclusion criteria

- women undergoing cesarean section
- 18 years older

Minimum age

18 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

- chronic hypertension,
- preeclampsia,
- gestational diabetes,
- pre-pregnancy obesity
- history of previous pregnancy complication
- severe medical conditions such as immunocompromised host, active pulmonary tuberculosis, chronic structural pulmonary disease, pulmonary hypertension, and hyperthyroidism

Study design

Purpose

Duration

Selection

Timing

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

4/09/2017

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

500

Accrual to date

100

Final

Recruitment outside Australia

Country [1]

Turkey

State/province [1]

Bursa

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Derya Karasu

Address [1]

Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/Bursa

Country [1]

Turkey

Primary sponsor type

Individual

Name

Derya Karasu

Address

Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/Bursa

Country

Turkey

Secondary sponsor category [1]

Individual

Name [1]

Canan Yilmaz

Address [1]

Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/Bursa

Country [1]

Turkey

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Yuksek Ihtisas Training and Education Hospital Clinical Researc Ethics Committee

Ethics committee address [1]

Bursa Yuksek Ihtisas Training Education Hospital Clinic of Anesthesiology and Reanimation 
Mimar Sinan Neighborhood /Emniyet Street/16310 Yildirim/Bursa

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

Approval date [1]

01/02/2017

Ethics approval number [1]

Summary

Brief summary

Sleep disordered breathing occurring during pregnancy is associated with adverse maternal and fetal outcomes as shown by several studies. The prevalence of sleep disordered in pregnancy remain uncertain, mainly due to different evaluation methods in various research studies, Lack of objective testing for definitive diagnosis in studies using only questionnaire screening. However, the prevalence of snoring increased during pregnancy. In the United States, 14% of healthy pregnancy are reported to be associated with snoring. 
Primary purpose of this study is investigating the fruquency of obstructive sleep apne with  Stop-Bang questionnaire in pregnant women undergoing cesarean section. ;The other purpose of this study is to examine the preferred methods of anesthesia by review of medical records.
In this prospective observational study, women undergoing cesarean section will recruite. Pregnancies are those with chronic hypertension, preeclampsia, gestational diabetes, pre-pregnancy obesity, or history of previous pregnancy complication. Women are eligible if they were  18 years older. The exclusion criteria are severe medical conditions such as immunocompromised host, active pulmonary tuberculosis, chronic structural pulmonary disease, pulmonary hypertension, and hyperthyroidism. All subjects will sign informed consent form in order to participate in the study.
Demographic data including body weight, body mass index, neck circumference, blood pressure, and will collect. Screening evaluations for obstructive sleep apnea syndrome included Stop-Bang questionnaire,The STOP-BANG questionnaire consists of snoring,  tired, observed, blood pressure, body mass index, age, neck circumference, and gender. Preferred anesthesia methods will be examined.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Derya Karasu

Address

Bursa Yuksek Ihtisas Training Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood /Emniyet Street/16310 Yildirim/Bursa

Country

Turkey

Phone

+905057281175

Fax

drderyatopuz@gmail.com

Contact person for public queries

Name

Derya Kaarsu

Address

Bursa Yuksek Ihtisas Training Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood /Emniyet Street/16310 Yildirim/Bursa

Country

Turkey

Phone

+905057281175

Fax

drderyatopuz@gmail.com

Contact person for scientific queries

Name

canan yilmaz

Address

Bursa Yuksek Ihtisas Training Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood /Emniyet Street/16310 Yildirim/Bursa

Country

Turkey

Phone

+905059045989

Fax

dr_cnnylmz@yahoo.com

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically