Continuous positive airway pressure versus usual care for obstructive sleep apnoea in pregnancy: a two-step pilot trial
Abstract Background Obstructive sleep apnoea (OSA) is associated with increasing body mass index (BMI) and affects up to 15% of pregnant women. OSA in pregnancy can be associated with adverse maternal and neonatal outcomes. Continuous positive airway pressure (CPAP) may be an effective treatment for...
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BMC
2025-06-01
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| Series: | Pilot and Feasibility Studies |
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| Online Access: | https://doi.org/10.1186/s40814-025-01645-1 |
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| author | Rachael Nugent Caroline de Costa Leonie Callaway Shiv Erigadoo Elise Gilbertson Chris Brown Joanna Perry-Keene Rebekah Shakhovskoy Lauren Kearney |
| author_facet | Rachael Nugent Caroline de Costa Leonie Callaway Shiv Erigadoo Elise Gilbertson Chris Brown Joanna Perry-Keene Rebekah Shakhovskoy Lauren Kearney |
| author_sort | Rachael Nugent |
| collection | DOAJ |
| description | Abstract Background Obstructive sleep apnoea (OSA) is associated with increasing body mass index (BMI) and affects up to 15% of pregnant women. OSA in pregnancy can be associated with adverse maternal and neonatal outcomes. Continuous positive airway pressure (CPAP) may be an effective treatment for OSA during pregnancy. Aim To examine the feasibility and acceptability of screening women with a BMI ≥ 35 kg/m2 for OSA in pregnancy, followed by randomisation to treatment with CPAP or no CPAP for women diagnosed with moderate to severe OSA. Methods This study was a single-centre, two-stage pilot study. Firstly, all consenting participants were screened for OSA and then, only if diagnosed with moderate to severe OSA (AHI ≥ 15), randomised to CPAP or no CPAP. The feasibility of the OSA screening was determined by recruitment rates. A priori criteria of > 20% recruitment to the sleep study were considered feasible. The acceptability of the sleep study was examined using the completion rate and reasons for withdrawal prior to the sleep study. The acceptability of CPAP randomisation was assessed by completion rates for women randomised, adherence to CPAP, reasons for withdrawal, and the review of quality-of-life measures over the course of pregnancy. Results Ninety-six women with a BMI ≥ 35 kg/m2 before 26 completed weeks of pregnancy were invited to participate from the Sunshine Coast University Hospital and Health Service. Overall, 36 women enrolled, giving a recruitment rate of 37%. A total of 75% (n = 26) of recruited women completed OSA screening (clinical history, questionnaires, and formal sleep study). Subsequently, six (6%) of invited women had an apnoea hypopnoea index (AHI) ≥ 15/h and were diagnosed with moderate to severe OSA and underwent randomisation to receive treatment with CPAP (n = 4) or no CPAP (n = 1) until birth. One woman withdrew after randomisation to treatment. Nine women withdrew prior to full completion of OSA screening and one following an inconclusive sleep study. Women who had a sleep study found it acceptable, and in women randomised to CPAP, adherence averaged 4.86 h/night. Quality-of-life measures were similar when measured over two time points in pregnancy. Discussion A definitive trial screening women for OSA and subsequent randomisation to treatment or no treatment may be feasible. Future trials should be resourced to expand inclusion criteria, improve accessibility for participants, evaluate clinical and cost-effectiveness, and investigate partial treatment effects. Trial registration ACTRN, ACTRN12621001523897. Registered 9 September 2021 — retrospectively registered, https://www.anzctr.org.au/Trial/Update/Step8_Update.aspx?id=382640. |
| format | Article |
| id | doaj-art-9dda64ba5a2a4f6288bba02442815b2a |
| institution | DOAJ |
| issn | 2055-5784 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | BMC |
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| series | Pilot and Feasibility Studies |
| spelling | doaj-art-9dda64ba5a2a4f6288bba02442815b2a2025-08-20T03:10:31ZengBMCPilot and Feasibility Studies2055-57842025-06-0111111110.1186/s40814-025-01645-1Continuous positive airway pressure versus usual care for obstructive sleep apnoea in pregnancy: a two-step pilot trialRachael Nugent0Caroline de Costa1Leonie Callaway2Shiv Erigadoo3Elise Gilbertson4Chris Brown5Joanna Perry-Keene6Rebekah Shakhovskoy7Lauren Kearney8Sunshine Coast Hospital and Health ServiceJames Cook UniversityUniversity of QueenslandSunshine Coast Hospital and Health ServiceSunshine Coast Hospital and Health ServiceSunshine Coast Hospital and Health ServiceSunshine Coast Hospital and Health ServiceSunshine Coast Hospital and Health ServiceUniversity of QueenslandAbstract Background Obstructive sleep apnoea (OSA) is associated with increasing body mass index (BMI) and affects up to 15% of pregnant women. OSA in pregnancy can be associated with adverse maternal and neonatal outcomes. Continuous positive airway pressure (CPAP) may be an effective treatment for OSA during pregnancy. Aim To examine the feasibility and acceptability of screening women with a BMI ≥ 35 kg/m2 for OSA in pregnancy, followed by randomisation to treatment with CPAP or no CPAP for women diagnosed with moderate to severe OSA. Methods This study was a single-centre, two-stage pilot study. Firstly, all consenting participants were screened for OSA and then, only if diagnosed with moderate to severe OSA (AHI ≥ 15), randomised to CPAP or no CPAP. The feasibility of the OSA screening was determined by recruitment rates. A priori criteria of > 20% recruitment to the sleep study were considered feasible. The acceptability of the sleep study was examined using the completion rate and reasons for withdrawal prior to the sleep study. The acceptability of CPAP randomisation was assessed by completion rates for women randomised, adherence to CPAP, reasons for withdrawal, and the review of quality-of-life measures over the course of pregnancy. Results Ninety-six women with a BMI ≥ 35 kg/m2 before 26 completed weeks of pregnancy were invited to participate from the Sunshine Coast University Hospital and Health Service. Overall, 36 women enrolled, giving a recruitment rate of 37%. A total of 75% (n = 26) of recruited women completed OSA screening (clinical history, questionnaires, and formal sleep study). Subsequently, six (6%) of invited women had an apnoea hypopnoea index (AHI) ≥ 15/h and were diagnosed with moderate to severe OSA and underwent randomisation to receive treatment with CPAP (n = 4) or no CPAP (n = 1) until birth. One woman withdrew after randomisation to treatment. Nine women withdrew prior to full completion of OSA screening and one following an inconclusive sleep study. Women who had a sleep study found it acceptable, and in women randomised to CPAP, adherence averaged 4.86 h/night. Quality-of-life measures were similar when measured over two time points in pregnancy. Discussion A definitive trial screening women for OSA and subsequent randomisation to treatment or no treatment may be feasible. Future trials should be resourced to expand inclusion criteria, improve accessibility for participants, evaluate clinical and cost-effectiveness, and investigate partial treatment effects. Trial registration ACTRN, ACTRN12621001523897. Registered 9 September 2021 — retrospectively registered, https://www.anzctr.org.au/Trial/Update/Step8_Update.aspx?id=382640.https://doi.org/10.1186/s40814-025-01645-1PregnancyContinuous positive airway pressureObstructive sleep apnoeaObesity |
| spellingShingle | Rachael Nugent Caroline de Costa Leonie Callaway Shiv Erigadoo Elise Gilbertson Chris Brown Joanna Perry-Keene Rebekah Shakhovskoy Lauren Kearney Continuous positive airway pressure versus usual care for obstructive sleep apnoea in pregnancy: a two-step pilot trial Pilot and Feasibility Studies Pregnancy Continuous positive airway pressure Obstructive sleep apnoea Obesity |
| title | Continuous positive airway pressure versus usual care for obstructive sleep apnoea in pregnancy: a two-step pilot trial |
| title_full | Continuous positive airway pressure versus usual care for obstructive sleep apnoea in pregnancy: a two-step pilot trial |
| title_fullStr | Continuous positive airway pressure versus usual care for obstructive sleep apnoea in pregnancy: a two-step pilot trial |
| title_full_unstemmed | Continuous positive airway pressure versus usual care for obstructive sleep apnoea in pregnancy: a two-step pilot trial |
| title_short | Continuous positive airway pressure versus usual care for obstructive sleep apnoea in pregnancy: a two-step pilot trial |
| title_sort | continuous positive airway pressure versus usual care for obstructive sleep apnoea in pregnancy a two step pilot trial |
| topic | Pregnancy Continuous positive airway pressure Obstructive sleep apnoea Obesity |
| url | https://doi.org/10.1186/s40814-025-01645-1 |
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