Table 2.
Live-birth rate (primary outcome)
| Enoxaparin | Placebo | P | |
|---|---|---|---|
| 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) | 1 |
| 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.