Table II.
Pregnancy loss by treatment arm overall and among women who became pregnant: the EAGeR trial.
| Outcomes: N (%)a | Total | LDA | Placebo | Overall RR (95% CI) | Among pregnanciesb RR (95% CI) |
|---|---|---|---|---|---|
| Women who completed the trial | N = 1088 | N = 537 | N = 551 | — | — |
| hCG detected pregnancy | N = 785 | N = 405 | N = 380 | — | — |
| Any pregnancy loss | 188 (17.3) | 96 (17.9) | 92 (16.7) | 1.07 (0.83, 1.39) | 0.99 (0.78, 1.27) |
| Implantation failure | 55 (5.1) | 28 (5.2) | 27 (4.9) | 1.06 (0.64, 1.78) | 0.97 (0.59, 1.60) |
| PPT, no confirmation | 34 (3.1) | 18 (3.4) | 16 (2.9) | 1.15 (0.59, 2.24) | 1.10 (0.57, 2.12) |
| hCG, no PPT | 21 (1.9) | 10 (1.9) | 11 (2.0) | 0.93 (0.40, 2.18) | 0.80 (0.35, 1.82) |
| Clinical loss | 133 (12.2) | 68 (12.7) | 65 (11.8) | 1.07 (0.78, 1.48) | 1.00 (0.73, 1.36) |
| Pre-embryonic | 36 (3.3) | 17 (3.2) | 19 (3.5) | 0.92 (0.48, 1.75) | 0.91 (0.48, 1.71) |
| Embryonic | 73 (6.7) | 39 (7.3) | 34 (6.2) | 1.18 (0.75, 1.84) | 1.07 (0.69, 1.65) |
| Fetal pregnancy loss (<20 weeks) | 10 (0.9) | 4 (0.7) | 6 (1.1) | 0.68 (0.19, 2.41) | 0.61 (0.17, 2.23) |
| Stillbirth | 4 (0.4) | 2 (0.4) | 2 (0.4) | 1.03 (0.15, 7.26) | 0.97 (0.14, 6.74) |
| Ectopic | 6 (0.6) | 3 (0.6) | 3 (0.5) | 1.03 (0.21, 5.06) | 1.00 (0.19, 5.23) |
| Unknown | 4 (0.4) | 3 (0.6) | 1 (0.2) | 3.08 (0.32, 29.50) | 2.54 (0.28, 23.41) |
aPercentages calculated out of women who completed the trial.
bInverse probability weights were used to account for different rates of confirmed pregnancies by intervention arm and were based on factors associated with becoming pregnant, including maternal age, parity, marital status, number of prior losses and treatment assignment. Weighted log-binomial regression was used to estimate RRs and 95% CIs.