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STOPBANG As A Screening Tool for Obstructive Sleep Apnoea in Pregnancy

C

City Hospitals Sunderland NHS Foundation Trust

Status

Completed

Conditions

Obstructive Sleep Apnoea
Pregnancy

Treatments

Diagnostic Test: Overnight pulse oximetry
Other: Epworth Sleepiness Scale
Other: STOPBANG Questionnaire

Study type

Observational

Funder types

Other

Identifiers

NCT02542488
STOPBANGPREG

Details and patient eligibility

About

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.

Full description

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.

Enrollment

117 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Pregnant women
  • Body mass index ≥ 40 at first midwife appointment
  • Women ≥ 18 years of age

Exclusion criteria

  • Pre-existing obstructive sleep apnoea on treatment
  • 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

Trial design

117 participants in 1 patient group

Pregnant women with BMI >39 at booking
Description:
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.
Treatment:
Diagnostic Test: Overnight pulse oximetry
Other: Epworth Sleepiness Scale
Other: STOPBANG Questionnaire

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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