Treatment of obstructive sleep apnea in high risk pregnancy: a multicenter randomized controlled trial.

Visasiri Tantrakul, Atiporn Ingsathit, Somprasong Liamsombut, Sasivimol Rattanasiri, Prapun Kittivoravitkul, Nutthaphon Imsom-Somboon, Siwaporn Lertpongpiroon, Surasak Jantarasaengaram, Werapath Somchit, Worakot Suwansathit, Janejira Pengjam, Sukanya Siriyotha, Panyu Panburana, Christian Guilleminault, Aroonwan Preutthipan, John Attia, Ammarin Thakkinstian

Journal: Respiratory research 2023;24(1):171

PMID: 37370135

Plain Language Summary

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Preeclampsia is a leading cause of maternal and foetal morbidity and mortality. Obstructive sleep apnoea (OSA) during pregnancy has been identified as a risk factor for preeclampsia and gestational hypertension. Although continuous positive airway pressure (CPAP) is a standard treatment for OSA in the general population, there is limited data regarding the efficacy and safety of CPAP treatment during pregnancy. The aim of this study was to evaluate the efficacy of CPAP treatment in high-risk pregnancy with mild-to-moderate OSA in reducing BP and hypertensive disorders in pregnancy. This study was a multicentre, open-label, parallel-group randomised controlled trial. Pregnant women attending antenatal care at all collaborating hospitals were recruited. Results showed that CPAP significantly reduced blood pressure (BP), with larger effects on diastolic BP and mean arterial pressure than systolic BP. Furthermore, it reduced the incidence of preeclampsia and hypertensive disorders in pregnancy. Authors conclude that their findings raise the need for early diagnosis and treatment of OSA in high-risk pregnancies.

Abstract

BACKGROUND

Obstructive sleep apnea (OSA) during pregnancy is a risk factor for preeclampsia possibly through a link to placental physiology. This study evaluates the efficacy of continuous positive airway pressure (CPAP) on the modulation of blood pressure and the reduction in preeclampsia in women with high-risk pregnancy and OSA.

METHODS

A multicenter open-label, randomized controlled trial comparing CPAP treatment versus usual antenatal care was conducted in three academic hospitals in Bangkok, Thailand. Participants included singleton pregnant women aged older than 18 years with any high-risk condition (i.e., chronic hypertension, obesity, history of preeclampsia or gestational diabetes in the previous pregnancy, or diabetes), and OSA (respiratory disturbance index 5-29.99 events/hour by polysomnography), who presented either in the first trimester (gestational age, GA 0-16 weeks) or subsequently developed OSA during the 2nd trimester (GA 24-28 weeks). The primary endpoint was blood pressure during antenatal care. Secondary endpoints included the incidence of preeclampsia. An intention-to-treat analysis was performed with additional per-protocol and counterfactual analyses for handling of nonadherence.

RESULTS

Of 340 participants, 96.5% were recruited during the first trimester. Thirty participants were later excluded leaving 153 and 157 participants in the CPAP and usual-care groups for the modified-intention-to-treat analysis. CPAP adherence rate was 32.7% with average use of 2.5 h/night. Overall, CPAP treatment significantly lowered diastolic blood pressure (DBP) by - 2.2 mmHg [95% CI (- 3.9, - 0.4), p = 0.014], representing approximately - 0.5 mmHg per hour of CPAP use [95%CI (- 0.89, - 0.10), p = 0.013]. CPAP treatment also altered the blood pressure trajectory by continuously lowering DBP throughout pregnancy with mean differences (95% CI) of - 3.09 (- 5.34, - 0.93), - 3.49 (- 5.67, - 1.31) and - 3.03 (- 5.20, - 0.85) mmHg at GA 18-20, 24-28, and 32-34 weeks, respectively compared to 0-16 weeks. Preeclampsia rate was 13.1% (20/153 participants) in the CPAP and 22.3% (35/157 participants) in the usual-care group with a risk difference (95% CI) of - 9% (- 18%, - 1%, p-value = 0.032) and a number-needed-to-treat (95% CI) of 11 (1, 21).

CONCLUSIONS

CPAP treatment in women with even mild-to-moderate OSA and high-risk pregnancy demonstrated reductions in both DBP and the incidence of preeclampsia. CPAP treatment also demonstrated a sustained reduction in DBP throughout gestation. Trial registration ClinicalTrial.GovNCT03356106, retrospectively registered November 29, 2017.

© 2023. The Author(s).

Address: Department of Clinical Epidemiology and Biostatistics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.; Division of Sleep Medicine, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.; Division of Pulmonary and Critical Care, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.; Ramathibodi Hospital Sleep Disorder Center, Mahidol University, Bangkok, Thailand.; Department of Clinical Epidemiology and Biostatistics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. [email protected].; Division of Pulmonary and Critical Care, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.; Ramathibodi Hospital Sleep Disorder Center, Mahidol University, Bangkok, Thailand.; Department of Clinical Epidemiology and Biostatistics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.; Division of Pulmonary and Critical Care, Department of Medicine, Phramongkutklao Hospital, Bangkok, Thailand.; Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Phramongkutklao Hospital, Bangkok, Thailand.; Chest Unit, Rajavithi Hospital, Bangkok, Thailand.; Department of Obstetrics and Gynecology, Rajavithi Hospital, College of Medicine, Rangsit University, Bangkok, Thailand.; Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.; Ramathibodi Hospital Sleep Disorder Center, Mahidol University, Bangkok, Thailand.; Sleep Medicine Division, Stanford University, Redwood City, CA, USA.; Ramathibodi Hospital Sleep Disorder Center, Mahidol University, Bangkok, Thailand.; Division of Pediatric Pulmonary, Department of Pediatrics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.; School of Medicine and Public Health, Faculty of Health and Medicine, The University of Newcastle, Callaghan, Australia.

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