Treatment of obstructive sleep apnea in high risk pregnancy: a multicenter randomized controlled trial.
Blood pressure
Continuous positive airway pressure (CPAP)
Obstructive sleep apnea
Preeclampsia
Pregnancy
Journal
Respiratory research
ISSN: 1465-993X
Titre abrégé: Respir Res
Pays: England
ID NLM: 101090633
Informations de publication
Date de publication:
27 Jun 2023
27 Jun 2023
Historique:
received:
19
10
2022
accepted:
07
05
2023
medline:
29
6
2023
pubmed:
28
6
2023
entrez:
27
6
2023
Statut:
epublish
Résumé
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. 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. 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). 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.
Sections du résumé
BACKGROUND
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
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
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
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.
Identifiants
pubmed: 37370135
doi: 10.1186/s12931-023-02445-y
pii: 10.1186/s12931-023-02445-y
pmc: PMC10294320
doi:
Banques de données
ClinicalTrials.gov
['NCT03356106']
Types de publication
Randomized Controlled Trial
Multicenter Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
171Informations de copyright
© 2023. The Author(s).
Références
J Clin Sleep Med. 2015 Jan 15;11(2):157-63
pubmed: 25406273
J Clin Sleep Med. 2012 Aug 15;8(4):389-94
pubmed: 22893769
J Clin Sleep Med. 2012 Oct 15;8(5):597-619
pubmed: 23066376
Sleep Med. 2000 Jul 1;1(3):215-220
pubmed: 10828432
Am J Respir Crit Care Med. 2003 Jan 15;167(2):137-40
pubmed: 12411285
Best Pract Res Clin Obstet Gynaecol. 2011 Aug;25(4):391-403
pubmed: 21333604
Obstet Gynecol. 2019 Jan;133(1):1
pubmed: 30575668
Am J Obstet Gynecol. 2018 Dec;219(6):613.e1-613.e10
pubmed: 30217579
JAMA Pediatr. 2018 Jan 2;172(1):e174064
pubmed: 29131887
Sleep Breath. 2023 May;27(2):621-629
pubmed: 35750926
Eur Respir J. 2010 Oct;36(4):849-55
pubmed: 20525714
J Clin Sleep Med. 2013 Apr 15;9(4):311-7
pubmed: 23585744
Sleep Med. 2004 Jan;5(1):43-51
pubmed: 14725826
Chest. 2014 Apr;145(4):762-771
pubmed: 24077181
J Clin Sleep Med. 2019 Feb 04;15(2):335-343
pubmed: 30736887
J Clin Sleep Med. 2022 Feb 01;18(2):423-432
pubmed: 34351847
J Clin Epidemiol. 2019 Apr;108:121-131
pubmed: 30528792
JAMA. 2018 Mar 6;319(9):883-895
pubmed: 29509864
Lancet. 2004 Mar 27;363(9414):1077
pubmed: 15051297
Can Respir J. 2016;2016:9816494
pubmed: 27974870
J Clin Sleep Med. 2018 Mar 15;14(3):327-336
pubmed: 29458699
Am J Obstet Gynecol. 2018 May;218(5):521.e1-521.e12
pubmed: 29523262
JAMA Netw Open. 2019 Jan 4;2(1):e186861
pubmed: 30646198
Am J Obstet Gynecol. 2012 Dec;207(6):487.e1-9
pubmed: 22999158
Pediatr Dev Pathol. 2015 Sep-Oct;18(5):380-6
pubmed: 26186234
Sleep Med. 2007 Dec;9(1):9-14
pubmed: 17644420
Obstet Gynecol. 2017 Jan;129(1):31-41
pubmed: 27926645
Clin Exp Hypertens. 2018;40(6):539-546
pubmed: 29172803
Obstet Med. 2018 Mar;11(1):32-34
pubmed: 29636812
Front Neurol. 2018 May 28;9:91
pubmed: 29892255
Eur Respir J. 2001 Oct;18(4):672-6
pubmed: 11716173
Am J Respir Crit Care Med. 2000 Jul;162(1):252-7
pubmed: 10903250
WMJ. 2021 Apr;120(1):34-40
pubmed: 33974763
J Obstet Gynaecol. 2021 Aug;41(6):915-919
pubmed: 33232186
J Reprod Immunol. 2019 Sep;134-135:1-10
pubmed: 31301487
Diabetes Res Clin Pract. 2018 Apr;138:229-237
pubmed: 29475019
Sleep Breath. 2022 Mar;26(1):297-305
pubmed: 34021466
Hypertension. 2012 Jun;59(6):1241-8
pubmed: 22526257
Sleep. 2019 May 1;42(5):
pubmed: 30753641
J Clin Sleep Med. 2016 Aug 15;12(8):1153-8
pubmed: 27166303
Eur Heart J. 2011 Dec;32(24):3088-97
pubmed: 21821845
Am Rev Respir Dis. 1991 Aug;144(2):461-3
pubmed: 1859076
BMJ. 2019 Jul 15;366:l2381
pubmed: 31307997
Obstet Gynecol. 2013 Nov;122(5):1122-1131
pubmed: 24150027
J Hypertens. 2012 Feb;30(2):342-50
pubmed: 22179091
Expert Rev Respir Med. 2019 Apr;13(4):317-326
pubmed: 30689957
Semin Nephrol. 2011 Jan;31(1):33-46
pubmed: 21266263
BMC Pregnancy Childbirth. 2019 May 28;19(1):186
pubmed: 31138157
BMC Pulm Med. 2014 Sep 26;14:153
pubmed: 25257571
Am J Obstet Gynecol MFM. 2023 Mar;5(3):100840
pubmed: 36563879
J Perinat Med. 2015 Jan;43(1):81-7
pubmed: 24846956
J Clin Invest. 1995 Oct;96(4):1897-904
pubmed: 7560081
Eur Respir J. 2006 Feb;27(2):328-33
pubmed: 16452588
Arch Gynecol Obstet. 2015 Apr;291(4):819-23
pubmed: 25241271
Sleep Med. 2014 May;15(5):550-5
pubmed: 24726569
BMJ. 2017 Dec 22;359:j5542
pubmed: 29273586
Sleep. 2019 Jun 11;42(6):
pubmed: 30903184
Sleep Med. 2007 Dec;9(1):15-21
pubmed: 17644475
Am J Hypertens. 2001 Nov;14(11 Pt 1):1090-5
pubmed: 11724205