Table 4.
Time of treatment initiation and pregnancy outcome.
| Intention-to-treat population |
Fisher's exact test |
|||||
|---|---|---|---|---|---|---|
| Time at the start of administration | Administration | Ongoing pregnancy at 22 weeks of gestation– no./total no. (%) | 95% CI | p-value | Odds ratio (95% CI) | |
| Ongoing pregnancy at 22 weeks of gestation | 4 or 5 weeks | Placebo | 9/36 (25·0) | 12·1–42·2 | <0·001 | 6·27 (2·21-17·78) |
| IVIG | 23/34 (67·6) | 49·5–82·6 | ||||
| 6 weeks | Placebo | 8/13 (61·5) | 31·6–86·1 | 0·71 | 0·63 (0·14-2·76) | |
| IVIG | 8/16 (50·0) | 24·7–75·3 | ||||
| Time at the start of administration | Administration | Live births– no./total no. (%) | 95% CI | p-value | Odds ratio (95% CI) | |
| Live birth | 4 or 5 weeks | Placebo | 9/36 (25·0) | 12·1–42·2 | 0·003 | 4·85 (1·74-13·49) |
| IVIG | 21/34 (61·8) | 43·6–77·8 | ||||
| 6 weeks | Placebo | 8/13 (61·5) | 31·6–86·1 | 0·71 | 0·66 (0·141-2·76) | |
| IVIG | 8/16 (50·0) | 24·7–75·3 | ||||
|
Modified intention-to-treat population |
Fisher's exact test |
|||||
| Time at the start of administration | Administration | Ongoing pregnancy at 22 weeks of gestation– no./total no. (%) | 95% CI | p-value | Odds ratio (95% CI) | |
| Ongoing pregnancy at 22 weeks of gestation | 4 or 5 weeks | Placebo | 9/28 (32·1) | 15·9–52·4 | 0·004 | 5·40 (1·79-16·30) |
| IVIG | 23/32 (71·9) | 53·3–86·3 | ||||
| 6 weeks | Placebo | 8/10 (80·0) | 44·4–97·5 | 0·23 | 0·29 (0·05-1·82) | |
| IVIG | 8/15 (53·3) | 26·6–78·7 | ||||
| Time at the start of administration | Administration | Live births– no./total no. (%) | 95% CI | p-value | Odds ratio (95% CI) | |
| Live birth | 4 or 5 weeks | Placebo | 9/28 (32·1) | 15·9–52·4 | 0·02 | 4·03 (1·37-11·84) |
| IVIG | 21/32 (65·6) | 46·8–81·4 | ||||
| 6 weeks | Placebo | 8/10 (80·0) | 44·4–97·5 | 0·23 | 0·26 (0·04-1·82) | |
| IVIG | 8/15 (53·3) | 26·6–78·7 | ||||