Table 2.
Pregnancy incidence and outcomes by study arm
| Placebo | Dapivirine | Overall | |||||
|---|---|---|---|---|---|---|---|
| Pregnancy incidence | |||||||
| Number of pregnancies | 93 | 86 | 179 | ||||
| Pregnancy incidence (95% CI)* | 4.3 | (3.4–5.5) | 4.0 | (3.1–5.1) | 4.1 | (3.5–4.9) | |
| Pregnancy outcomes | N=94** | N=87 | N=181** | ||||
| Full term birth | 53 | (56%) | 52 | (60%) | 105 | (58%) | |
| Preterm birth | 9 | (10%) | 0 | (0%) | 9 | (5%) | |
| Stillbirth/intrauterine fetal demise | 2 | (2%) | 2 | (2%) | 4 | (2%) | |
| Spontaneous abortion | 21 | (22%) | 18 | (21%) | 39 | (22%) | |
| Therapeutic/elective abortion | 8 | (9%) | 14 | (16%) | 22 | (12%) | |
| Ectopic pregnancy | 1 | (1%) | 1 | (1%) | 2 | (1%) | |
| Congenital anomalies | N=59 | N=48 | N=107 | ||||
| Any congenital anomaly | 4 | (7%) | 4 | (8%) | 8 | (7%) | |
*
Per 100 person-years
**
175 pregnancies resulted in a single outcome, 3 pregnancies resulted in two outcomes (twins), and 1 pregnancy had no outcome available, resulting in a total of 181 pregnancy outcomes.