Table 2. Risk of negative pregnancy outcomes and malformations for fetuses exposed to OCV (primary analysis) and fetuses not exposed but born to vaccinated women (bias-indicator analysis).
Boffa prefecture, Guinea, 2013.
| Primary and secondary analyses | Bias-indicator analysis | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fetus exposed (n = 1312) | Fetus non-exposed (n = 272) | Unadjusted relative risk | Adjusted relative risk | Unadjusted relative risk | Adjusted relative risk | ||||||||||||
| N | CCI% [95%CI] | N | CCI% [95%CI] | uRR | [95%CI] | p-value | aRR | [95%CI] | p-value | uRR | [95%CI] | p-value | aRR | [95%CI] | p-value | ||
| Pregnancy loss | 49 | 3.7 [2.7–4.8] | 7 | 2.6 [0 7–4.5] | 1.45 | [0.66–3.17] | 0.350 | 1.13 a | [0.54–2.38] | 0.738 | 1.06 | [0.36–3.14] | 0.915 | 1.19 | [0.47–3.00] | 0.717 | |
| Miscarriage* | 12 | 1.4 [0.6–2.2] | 2 | 1.0 [<0 1–2.4] | 1.36 | [0.31–6.08] | 0.689 | 1.29 b | [0.29–5.79] | 0.736 | 0.80 | [0.16–3.91] | 0.779 | 0.92 | [0.19–4.38] | 0.915 | |
| Stillbirth** | 36 | 2.8 [1.9–3.7] | 5 | 1.9 [0 2–3.5] | 1.50 | [0.59–3.79] | 0.394 | 1.39 c | [0.57–3.38] | 0.464 | 1.32 | [0.29–5.99] | 0.716 | 1.36 | [0.34–5.42] | 0.658 | |
| Live birth | 1263 | / | 265 | / | / | / | / | / | |||||||||
| Death | 18 | 1.4 [0.7–2.1] | 5 | 1.9 [0.2–3.5] | / | / | / | / | |||||||||
| Illnessⱡ | 107 | / | 15 | / | / | / | / | / | |||||||||
| Malformationⱡ | 7 | 0.6 [0.1–1.0] | 3 | 1.2 [0.0–2.5] | 0.49 | [0.13–1.87] | 0.296 | 0.50 d | [0 13–1 91] | 0.314 | 0.45 | [0.11–1.86] | 0.269 | 0.51 | [0.13–2.02] | 0.341 | |
CCI: Crude Cumulative Incidence
CI: Confidence Interval
uRR/aRR: Unadjusted/adjusted Relative Risk
* Women who had been pregnant for more than 5 months on 18 April 2012 were excluded.
** Women who did not complete 5 months of pregnancy were excluded.
ⱡ According to pediatrician’s examination
a Adjusted for subprefecture, household size, antenatal care, multiple pregnancies, number of live babies delivered, number of previous stillbirths, whether they had cholera in 2012.
b Adjusted for age, level of education, household size, previous child alive or dead, whether they had cholera in 2012.
c Adjusted for profession, household size, antenatal care, multiple pregnancies, number of previous miscarriages, number of previous stillbirths, whether they had cholera in 2012.
d Adjusted for profession, radio owned by the household, consumption of coffee during the pregnancy.