Table 2

Live-birth rate (primary outcome)

EnoxaparinPlaceboP
Intention-to-treat analysis, n 138 118  
Live birth, n (%) 92 (66.6) 86 (72.9) .34 
 Relative risk (95% CI) 0.91 (0.78 to 1.07)  
 Absolute difference in live-birth rate (95% CI) −6 (−17.1 to 5.1) 
Per-protocol analysis, n 116 101  
Live birth, n (%) 85 (73.3) 74 (73.3) 
 Relative risk (95% CI) 1 (0.85-1.17)  
 Absolute difference in live-birth rate (95% CI) 0 (−12 to 12) 
EnoxaparinPlaceboP
Intention-to-treat analysis, n 138 118  
Live birth, n (%) 92 (66.6) 86 (72.9) .34 
 Relative risk (95% CI) 0.91 (0.78 to 1.07)  
 Absolute difference in live-birth rate (95% CI) −6 (−17.1 to 5.1) 
Per-protocol analysis, n 116 101  
Live birth, n (%) 85 (73.3) 74 (73.3) 
 Relative risk (95% CI) 1 (0.85-1.17)  
 Absolute difference in live-birth rate (95% CI) 0 (−12 to 12) 

The women included in the per-protocol analysis were treated at least 7 days until loss or beyond 12 weeks’ gestation, and the injections were started before 6 weeks’ gestation or at least 1 week before the most advanced term reached before during previous pregnancies.

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