Table 3.
Side effects and adverse events by study group*a
| Misoprostol (800mcg SL) n = 40 |
Placebo n = 39 |
RR 95% CI | P value | |
|---|---|---|---|---|
| Shivering | 33 (82.5) | 24 (61.5) | 1.34 (0.98, 1.74) | 0.05 |
| Fever | 4 (10.0) | 7 (17.9) | 0.56 (0.14, 1.97) | 0.35 |
| Vomiting | 6 (15.0) | 7 (17.9) | 0.84 (0.27, 2.58) | 0.72 |
| Fainting | 2 (5.0) | 1 (2.6) | 1.95 (0.14, 54.1) | 1.0 |
| Nausea | 6 (15.0) | 5 (12.8) | 1.17 (0.34, 4.19) | 0.78 |
| Side effects reported as acceptable b | 31/35 (88.6) | 34/35 (97.1) | 0.91 (0.86, 1.06) | 0.36 |
| Maternal death | 0 | 1 | ||
| Neonatal death | 0 | 1 |
Abbreviations: SL sublingual, RR relative risk, CI confidence interval
* Data are presented as n (%)
a Among those who received the study treatment, all received 600mcg oral misoprostol as prophylaxis with the exception of 4 women (1 in misoprostol arm; 3 in placebo arm)
b In nine cases participants did not report on acceptability of side effects (5 in misoprostol arm; 4 in placebo arm)