None listed
Conditions
Brief summary
Our study's primary aim is to inform the feasibility and recruitability of a larger scale RCT to investigate maternal and foetal outcomes after diagnosis and treatment of moderate-severe OSA in pregnancy. We aim to test women with body mass index greater than or equal to 35 for sleep apnoea, and determine if treating moderate to severe disease will in pregnancy will impact maternal or neonatal outcomes. Additionally we will investigate if the intervention is acceptable to women, and if it has any impact on their quality of life, or any impact on placental histology after the birth of their baby. Additionally we will assess the predictive utility of questionnaires, BMI, neck circumference in OSA in pregnancy.
Interventions
Women will be recruited and if eligible will undertake a sleep study. Women less than 24 weeks gestation will be eligible for recruitment.
Women with an Apnea Hypopnea Index (AHI) greater than or equal to 15 will then be randomised to the intervention or standard care arm. Women with an AHI less than 15 will follow a standard care pathway (as per Queensland Health guidelines). If the participant is in the intervention arm, the following will be additional requirements:
• If the sleep study ind
Women will be recruited and if eligible will undertake a sleep study. Women less than 24 weeks gestation will be eligible for recruitment. Women with an Apnea Hypopnea Index (AHI) greater than or equal to 15 will then be randomised to the intervention or standard care arm. Women with an AHI less than 15 will follow a standard care pathway (as per Queensland Health guidelines). If the participant is in the intervention arm, the following will be additional requirements: • If the sleep study indicates moderate to severe sleep apnoea (AHI greater than or equal to 15), the participant will be asked to use a CPAP device for the remainder of the pregnancy. This includes comprehensive fitting and advice regarding the use of the device. This session will be undertaken by a CPAP technician and will take approximately 2 hours, a week prior to the commencement of CPAP. Recommendations for duration of CPAP will be from the time of mask fitting for the duration of the pregnancy, for at least 4 hours per night for at least 5 nights per week. • Data will be collected regarding duration of use in pregnancy (depending on gestational age at commencement of treatment and birth), and also from the device itself regarding adherence overnight.
Sponsors
The Sunshine Coast University Hospital and Health Service
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligibility: - Women with a Body Mass Index (BIM) equal to or greater than 35 - > 18 years of age - Singleton gestation - <24 weeks at booking visit/recruitment - low risk first trimester screen and a normal morphology ultrasound (if done prior to recruitment)
Exclusion criteria
- known sleep disordered breathing with mechanical therapy - patient declines randomisation - multiple gestation - fetal anomalies or high risk first trimester screen - women with coronary artery disease or congestive heart failure or cardiomyopathy - inability to read or understand the consent
Outcome results
None listed