Table 3.
Prevalence and relative risk of non‐defect adverse pregnancy outcomes: ZDV versus non‐ZDV ARV exposed, reported to the Antiretroviral Pregnancy Registry, prospective data through July 31, 2013
| Birth outcomes | Regimens containing ZDV | Regimens excluding ZDV | Relative riskg (95% CI) | P‐valueg | ||
|---|---|---|---|---|---|---|
| n (%) | Prevalence (%) (95% CI) | n (%) | Prevalence (%) (95% CI) | |||
| Live births | 12 278 (96.1) | – | 1633 (85.8) | – | – | |
| Spontaneous Abortions a | 171 (1.3) | 1.34 (1.15, 1.55) | 145 (7.6) | 7.62 (6.46, 8.90) | 0.18 (0.14, 0.22) | <0.0001 |
| Stillbirths a | 147 (1.2) | 1.15 (0.97, 1.35) | 29 (1.5) | 1.52 (1.02, 2.18) | 0.76 (0.51, 1.12) | 0.17 |
| Induced abortions a | 184 (1.4) | 1.44 (1.24, 1.66) | 97 (5.1) | 5.09 (4.15, 6.18) | 0.28 (0.22, 0.36) | <0.0001 |
| Total adverse birth outcomes b | 502 (3.9) | – | 271 (14.2) | – | – | – |
| Birth weight c | n e = 11044 | – | n e = 1508 | – | – | – |
| <2500 g | 1811 (16.4) | 16.40 (15.71, 17.10) | 212 (14.1) | 14.06 (12.34, 15.92) | 1.17 (1.02, 1.33) | 0.02 |
| <1500 g | 232 (2.1) | – | 28 (1.9) | – | – | – |
| Unknown | 881 | – | 89 | – | – | – |
| Gestational Age d | n f = 11907 | – | n f = 1587 | – | – | – |
| <37 weeks | 1467 (12.3) | 12.32 (11.74, 12.92) | 196 (12.4) | 12.35 (10.77, 14.07) | 1.00 (0.87, 1.15) | 0.97 |
| <32 weeks | 257 (2.2) | – | 34 (2.1) | – | – | – |
| Unknown | 18 | – | 10 | – | – | – |
Percentages are based on the total outcomes in the respective analysis.
Prevalence is based on the number of pregnancies. 95% CI is based on the exact binomial (Clopper‐Pearson) method.
Total adverse birth outcomes include still births, spontaneous or induced abortions, and exclude birth defects in live births
Prevalence is based on the number of live singleton births – excludes cases with defects and cases with unknown birth weight. 95% CI is based on the exact binomial (Clopper‐Pearson) method.
Prevalence is based on the number of live singleton births – excludes cases with defects and cases with unknown gestational age. 95% CI is based on the exact binomial (Clopper‐Pearson) method.
Excludes cases with unknown birth weight
Excludes cases with unknown gestational age.
Relative Risk – Regimens Containing ZDV versus Regimens Excluding ZDV. The 95% CI is based on the normal asymptotic method. P‐value is based on the Fisher's Exact test.