Nugent Rachael, de Costa Caroline, Callaway Leonie, Erigadoo Shiv, Gilbertson Elise, Brown Chris, Perry-Keene Joanna, Shakhovskoy Rebekah, Kearney Lauren
Sunshine Coast Hospital and Health Service, Birtinya, QLD, 4575, Australia.
University of Queensland, Brisbane, Australia.
Pilot Feasibility Stud. 2025 Jun 5;11(1):79. doi: 10.1186/s40814-025-01645-1.
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.
To examine the feasibility and acceptability of screening women with a BMI ≥ 35 kg/m for OSA in pregnancy, followed by randomisation to treatment with CPAP or no CPAP for women diagnosed with moderate to severe OSA.
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.
Ninety-six women with a BMI ≥ 35 kg/m 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.
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.
ACTRN, ACTRN12621001523897. Registered 9 September 2021 - retrospectively registered, https://www.anzctr.org.au/Trial/Update/Step8_Update.aspx?id=382640.
阻塞性睡眠呼吸暂停（OSA）与体重指数（BMI）增加相关，影响高达15%的孕妇。妊娠期OSA可能与不良母婴结局有关。持续气道正压通气（CPAP）可能是妊娠期OSA的有效治疗方法。
研究对孕期BMI≥35kg/m²的女性进行OSA筛查的可行性和可接受性，随后将被诊断为中度至重度OSA的女性随机分为接受CPAP治疗组或不接受CPAP治疗组。
本研究是一项单中心、两阶段的试点研究。首先，对所有同意参与的参与者进行OSA筛查，然后，只有被诊断为中度至重度OSA（呼吸暂停低通气指数[AHI]≥15）的参与者才被随机分为接受CPAP治疗组或不接受CPAP治疗组。OSA筛查的可行性由招募率决定。预先设定的招募率>20%参与睡眠研究被认为是可行的。使用完成率和睡眠研究前退出的原因来检查睡眠研究的可接受性。通过随机分组女性的完成率、对CPAP的依从性、退出原因以及孕期生活质量测量指标的回顾来评估CPAP随机分组的可接受性。
邀请了阳光海岸大学医院和卫生服务中心的96名妊娠26周前BMI≥35kg/m²的女性参与研究。总体而言，36名女性登记参与，招募率为37%。共有75%（n = 26）登记参与的女性完成了OSA筛查（临床病史、问卷调查和正式睡眠研究）。随后，6名（6%）受邀女性的呼吸暂停低通气指数（AHI）≥15/h，被诊断为中度至重度OSA，并随机分为接受CPAP治疗（n = 4）或不接受CPAP治疗（n = 1）直至分娩。一名女性在随机分组接受治疗后退出。9名女性在OSA筛查完全完成前退出，一名女性在睡眠研究结果不明确后退出。进行睡眠研究的女性认为该研究是可接受的，在随机分组接受CPAP治疗的女性中，平均每晚依从时间为4.86小时。在孕期的两个时间点测量时，生活质量测量指标相似。
对女性进行OSA筛查并随后随机分为接受治疗或不接受治疗的确定性试验可能是可行的。未来的试验应获得资源以扩大纳入标准、提高参与者的可及性、评估临床和成本效益，并研究部分治疗效果。
澳大利亚新西兰临床试验注册中心，ACTRN12621001523897。2021年9月9日注册——追溯注册，https://www.anzctr.org.au/Trial/Update/Step8_Update.aspx?id=382640。
