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

Respiratory Research

Table 4 Primary outcomes on blood pressures using the modified intention-to-treat analysis

Modified intention-to-treat analysis
Mean (SE)^a	CPAP (n = 153)			Usual-care (n = 157)			Overall mean		Intergroup difference (95%CI)^c	p value	Adjusted intergroup difference (95%CI)^d	p value
Mean (SE)^a	18–20 weeks^b	24–28 weeks	32–34 weeks	18–20 weeks^b	24–28 weeks	32–34 weeks	CPAP vs control		Intergroup difference (95%CI)^c	p value	Adjusted intergroup difference (95%CI)^d	p value
SBP	114.7 (1.0)	112.5 (1.0)	115.2 (1.0)	116.7 (1.0)	114.4 (1.0)	117.2 (1.0)	114.1 (1.0)	116.1 (0.9)	− 1.9 (− 4.5, 0.6)	0.148	− 2.08 (− 4.41, 0.26)	0.082
DBP	70.4 (0.7)	69.3 (0.7)	71.3 (0.7)	72.6 (0.7)	71.5 (0.7)	73.8 (0.7)	70.4 (0.6)	72.5 (0.6)	− 2.2 (− 3.9, − 0.4)	0.014	− 2.22 (− 3.70, − 0.75)	0.003
MAP	85.2 (0.8)	83.7 (0.8)	86.0 (0.8)	87.3 (0.7)	85.8 (0.7)	88.0 (0.7)	85.0 (0.7)	87.0 (0.7)	− 2.1 (− 3.9, − 0.2)	0.034	− 2.17 (− 3.83, − 0.52)	0.010

CPAP continuous positive airway pressure; DBP diastolic blood pressure; MAP mean arterial pressure; SBP systolic blood pressure; SE standard error; 95%CI 95% confidence interval
^aPrimary outcome on systolic and diastolic blood pressures are shown as means and SE estimated at each time point from the mixed-effect linear regression
^bBlood pressure data during 18–20 weeks gestation from participants who were randomized during 2nd trimester in both CPAP (n = 6) and usual-care groups (n = 6) were not included in the analyses
^cIntergroup difference is calculated as difference of marginal means (overall mean) between CPAP compared to the usual-care groups using mixed-effect linear regression model after randomization presented as mean difference and 95% CI
^dAdjusted intergroup difference is calculated as difference of marginal mean between CPAP compared to the usual-care groups using a mixed-effect linear regression model after randomization presented as mean difference and 95%CI adjusted with underlying chronic hypertension status, anti-hypertensive medication use and gestational age

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