STOPBANG As A Screening Tool for Obstructive Sleep Apnoea in Pregnancy
NCT ID: NCT02542488
Last Updated: 2019-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
117 participants
OBSERVATIONAL
2016-02-02
2018-03-27
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pregnant women with BMI >39 at booking
All women will receive routine care and in addition will complete the 8 question STOPBANG screening tool, an Epworth sleepiness scale and have overnight oximetry recorded.
STOPBANG Questionnaire
8 question screening tool comprised of the following questions:
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?
Overnight pulse oximetry
All participants will be given a Masimo Rad8 pulse oximeter to take home and apply to their finger overnight to measure their heart rate and oxygen saturations while they sleep.
Epworth Sleepiness Scale
A questionnaire that rates how tired they are doing everyday tasks
Interventions
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STOPBANG Questionnaire
8 question screening tool comprised of the following questions:
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?
Overnight pulse oximetry
All participants will be given a Masimo Rad8 pulse oximeter to take home and apply to their finger overnight to measure their heart rate and oxygen saturations while they sleep.
Epworth Sleepiness Scale
A questionnaire that rates how tired they are doing everyday tasks
Eligibility Criteria
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Inclusion Criteria
* Body mass index ≥ 40 at first midwife appointment
* Women ≥ 18 years of age
Exclusion Criteria
* Pre-existing restrictive or obstructive respiratory disease
* Women with another cause of sleep apnoea (e.g. central sleep apnoea)
* Women under 18 years of age
* Women who do not provide or refuse consent
* Women lacking capacity to consent
18 Years
FEMALE
Yes
Sponsors
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City Hospitals Sunderland NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Sean Cope, MBBS
Role: PRINCIPAL_INVESTIGATOR
Consultant Anaesthetist
Locations
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Sunderland Royal Hospital
Sunderland, Tyne and Wear, United Kingdom
Countries
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References
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Pearson F, Batterham AM, Cope S. The STOP-Bang Questionnaire as a Screening Tool for Obstructive Sleep Apnea in Pregnancy. J Clin Sleep Med. 2019 May 15;15(5):705-710. doi: 10.5664/jcsm.7754.
Related Links
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Information about STOPBANG validation
Other Identifiers
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STOPBANGPREG
Identifier Type: -
Identifier Source: org_study_id
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