STOPBANG As A Screening Tool for Obstructive Sleep Apnoea in Pregnancy

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Obstructive Sleep Apnoea
• Intervention / Treatment: Other: STOPBANG Questionnaire; Diagnostic test: Overnight pulse oximetry; Other: Epworth Sleepiness Scale

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 117

Contacts and Locations

Study Locations

• United Kingdom
  • Tyne And Wear
    • Sunderland, Tyne And Wear, United Kingdom, SR4 7TP
      • Sunderland Royal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Pregnant women booked to deliver at Sunderland Royal Hospital who have a body mass index ≥40 at their first midwife appointment.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Other: 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?; Diagnostic test: 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.; Other: Epworth Sleepiness Scale; A questionnaire that rates how tired they are doing everyday tasks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Obstructive Sleep Apnoea	Oxygen desaturation index (4% from baseline) > 5 per hour	Between weeks 17-28 of pregnancy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
STOPBANG score	Snore, Tired, Observed to Stop Breathing, high blood Pressure, BMI, Age, Neck circumference, Gender	Between weeks 17-28 of pregnancy
Modified STOPBANG score	Snore, Epworth > 10, Observed to Stop Breathing, high blood Pressure, BMI, Age, Neck circumference, Gender	Between weeks 17-28 of pregnancy

Collaborators and Investigators

• Sponsor: City Hospitals Sunderland NHS Foundation Trust
• Investigators: Principal Investigator: Sean Cope, MBBS, Consultant Anaesthetist

Publications and helpful links

General Publications

• 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.

Helpful Links

• Information about STOPBANG validation

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2016
• Primary Completion (Actual): August 31, 2017
• Study Completion (Actual): March 27, 2018

Study Registration Dates

• First Submitted: September 3, 2015
• First Submitted That Met QC Criteria: September 3, 2015
• First Posted (Estimate): September 7, 2015

Study Record Updates

• Last Update Posted (Actual): February 1, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: STOPBANGPREG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No