Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 31, 2023
Date Accepted: Nov 17, 2024
The effect of CPAP or Positional Therapy compared to control for treatment of OSA on the development of gestational diabetes mellitus in pregnancy (POSA): a protocol for a feasibility randomized controlled trial.
ABSTRACT
Background:
Obstructive sleep apnoea (OSA) is a common sleep disorder and in pregnancy is associated with an increased risk of complications, including gestational diabetes mellitus and preeclampsia. Supine sleep may worsen OSA, and in pregnancy, it is associated with an increased risk of stillbirth due to effects on fetomaternal blood flow. Continuous positive airway pressure (CPAP) therapy is considered gold standard treatment for moderate to severe OSA, though compliance is frequently poor; positional therapy (PT) is generally less effective than CPAP in nonpregnant patients but may be better tolerated and more accessible during pregnancy. There is limited data on whether widespread, early screening for sleep disorders in pregnant women with symptoms of sleep-disordered breathing or at high risk of metabolic complications and subsequent early intervention with CPAP or PT attenuates fetomaternal risks.
Objective:
This pilot study aims to determine the feasibility of treatment of OSA in a high-risk pregnant population using CPAP or PT by the 16th week of gestation.
Methods:
This study is a randomized, controlled, open label feasibility study in which pregnant women with an apnoea hypopnea index or respiratory disturbance index ≥5 are treated with CPAP (automatic titrating/fixed pressure) or positional therapy from early gestation (<16 weeks) until delivery. The primary outcome is the development of gestational diabetes mellitus by 28 weeks gestation. Secondary outcomes include the development of hypertensive disorders of pregnancy, maternal weight gain, uterine artery blood flow, glycemic control during pregnancy (in participants who develop gestational diabetes), changes in maternal circulating biomarkers and neonatal birthweight and complications. Polysomnography at 28-32 weeks gestation, post-partum polysomnography, therapy compliance and patient acceptability are also assessed.
Results:
The first participant was recruited on September 30, 2019.
Conclusions:
This is the first trial to compare early initiation of CPAP (automatic titrating and fixed pressure) and positional therapy in pregnant women with OSA with signs or symptoms of OSA, or at high risk of metabolic complications in pregnancy, making the findings of this study relevant to women who may otherwise be overlooked for screening for OSA during pregnancy. Clinical Trial: ANZCTR, ANZCTRN12619001530112. Registered 06 November 2019 - Retrospectively registered, https://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12619001530112
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