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临床试验/NCT02542488
NCT02542488已完成不适用

Use of the STOPBANG Questionnaire for Predicting Obstructive Sleep Apnoea in Pregnancy

City Hospitals Sunderland NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2016年2月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
117
试验地点
1
主要终点
Obstructive Sleep Apnoea

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Obstructive Sleep Apnoea

时间窗: Between weeks 17-28 of pregnancy

Oxygen desaturation index (4% from baseline) \> 5 per hour

次要结局

  • Modified STOPBANG score(Between weeks 17-28 of pregnancy)
  • STOPBANG score(Between weeks 17-28 of pregnancy)

研究者

发起方
City Hospitals Sunderland NHS Foundation Trust
申办方类型
Other
责任方
Sponsor

研究点 (1)

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