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Use of the STOPBANG Questionnaire for Predicting Obstructive Sleep Apnoea in Pregnancy
This study evaluates the use of the STOPBANG questionnaire to predict whether a pregnant woman with class III obesity has obstructive sleep apnoea. All participants will have a STOPBANG score and modified STOPBANG score (substituting Epworth score \> 10 with the tired item) calculated and then be tested with overnight pulse oximetry to see if they meet ODI criteria for obstructive sleep apnoea.
Obstructive sleep apnoea (OSA) is a condition in which the muscles and soft tissues of the throat collapse during sleep, resulting in them stopping breathing for a short period. It affects around 4% of all pregnant women and is more common in obese people. Pregnant women with untreated OSA are more likely to have pregnancy complications and are more likely to need a caesarean section. Babies born to mothers with untreated OSA are more likely to need neonatal treatment. If OSA is diagnosed and treated then these risks are reduced. In non-pregnant patients presenting for surgery, an screening tool called STOPBANG has been proven to be effective in identifying patients with OSA. S: Do you Snore loudly? T: Do you often feel tired during daytime? O: Has anyone observed you stop breathing during your sleep? P: Do you have high blood pressure? B: Is your BMI \>35 kg/m2? A: Are you \>50 years old? N: Is your neck circumference \>40cm? G: Is your gender male? The investigators aim to assess whether STOPBANG can be used to identify OSA in obese pregnant women. The aim is to recruit 100 pregnant women with a body mass index (BMI) ≥40 at Sunderland Royal Hospital. Data will be collected when they attend for their anomaly scan or glucose tolerance test (during the second trimester of pregnancy). Participants will complete an Epworth sleepiness scale questionnaire and the STOP questions before having their BMI, age and neck circumference documented. A STOPBANG score and Modified STOPBANG score (substitute tired question with Epworth \>10) will be calculated. All participants will then take a Rad8 pulse oximeter home to record their overnight pulse rate and oxygen saturations. The oximetry results will be analysed by a respiratory physiologist and the oxygen desaturation index will be calculated. A statistician will analyse the results to determine if there is a relationship between STOPBANG score or Modified STOPBANG score and likelihood of the pregnant women having OSA. In a secondary analysis we will then see if any individual elements of STOPBANG can be used to predict OSA.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
Yes
Sunderland Royal Hospital
Sunderland, Tyne and Wear, United Kingdom
Start Date
February 2, 2016
Primary Completion Date
August 31, 2017
Completion Date
March 27, 2018
Last Updated
February 1, 2019
117
ACTUAL participants
STOPBANG Questionnaire
OTHER
Overnight pulse oximetry
DIAGNOSTIC_TEST
Epworth Sleepiness Scale
OTHER
Lead Sponsor
City Hospitals Sunderland NHS Foundation Trust
NCT06768060
NCT07462065
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06273683