Trial Review

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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] 291572 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obstructive sleep apnea syndrome 302669 0
Condition category
Condition code
Respiratory 302188 302188 0 0
Sleep apnoea
Reproductive Health and Childbirth 302189 302189 0 0
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] 297636 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303493 0
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] 303493 0
First hour before surgery
Secondary outcome [1] 339067 0
to examine the preferred methods of anesthesia by review of medical records
Timepoint [1] 339067 0
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?
No
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] 9230 0
Turkey
State/province [1] 9230 0
Bursa

Funding & Sponsors
Funding source category [1] 296062 0
Self funded/Unfunded
Name [1] 296062 0
Derya Karasu
Country [1] 296062 0
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] 294952 0
Individual
Name [1] 294952 0
Canan Yilmaz
Address [1] 294952 0
Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/Bursa
Country [1] 294952 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297318 0
Yuksek Ihtisas Training and Education Hospital Clinical Researc Ethics Committee
Ethics committee address [1] 297318 0
Bursa Yuksek Ihtisas Training Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood /Emniyet Street/16310 Yildirim/Bursa
Ethics committee country [1] 297318 0
Turkey
Date submitted for ethics approval [1] 297318 0
Approval date [1] 297318 0
01/02/2017
Ethics approval number [1] 297318 0

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 73690 0
Dr Derya Karasu
Address 73690 0
Bursa Yuksek Ihtisas Training Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood /Emniyet Street/16310 Yildirim/Bursa
Country 73690 0
Turkey
Phone 73690 0
+905057281175
Fax 73690 0
Email 73690 0
[email protected]
Contact person for public queries
Name 73691 0
Dr Derya Kaarsu
Address 73691 0
Bursa Yuksek Ihtisas Training Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood /Emniyet Street/16310 Yildirim/Bursa
Country 73691 0
Turkey
Phone 73691 0
+905057281175
Fax 73691 0
Email 73691 0
[email protected]
Contact person for scientific queries
Name 73692 0
Dr canan yilmaz
Address 73692 0
Bursa Yuksek Ihtisas Training Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood /Emniyet Street/16310 Yildirim/Bursa
Country 73692 0
Turkey
Phone 73692 0
+905059045989
Fax 73692 0
Email 73692 0
[email protected]

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
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Documents added automatically
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