Table 4. Primary and Secondary Outcomes.
| Intervention Group | Control Group | ICC | Odds Ratio | P-value | ||
| (n = 405) | (n = 475) | (95% CI) | ||||
| n/N(%) | n/N(%) | |||||
| Primary Outcomes | Survived with severe morbiditya | 0/403 (0.0%) | 1/465 (0.2%) | – | – | |
| Mortality | 4/405 (1.0%) | 11/475 (2.3%) | 0.022 | 0.54 (0.14–2.05) | 0.37 | |
| Extreme adverse outcome | 4/403 (1.0%) | 12/465 (2.6%) | 0.019 | 0.46 (0.13–1.62) | 0.22 | |
| Secondary Outcomes | Blood loss in transit (mL)b,c | 205 (105–405) | 218 (95–461) | 1.04 (0.80–1.36)d | 0.75 | |
| Blood loss after arrivalc,e | 60 (30–280) | 50 (30–150) | 1.31 (0.79–2.16)d | 0.30 | ||
| Total blood lossc,f | 355 (160–655) | 336 (145–599) | 1.06 (0.76–1.49)d | 0.73 | ||
| Emergency hysterectomyg | 1/240 (0.4%) | 0/296 (0.0%) | – | – | ||
| Minutes to normal Shock Indexh | 170 (96–299) | 209 (114–386) | 1.25 (1.02–1.52)i | 0.03 |
Includes acute renal failure, acute respiratory distress syndrome, heart failure, cerebral impairment (seizures, unconsciousness, motor/cognitive loss) among women who survived.
The blood loss in transit was measured in 155 women in the Intervention Group and 175 women in the Control Group.
For each group the median and the interquartile range is reported.
For estimation of the effect the variable was transformed into the log metric for normality and the ratio of the mean is reported.
Blood loss after arrival was measured in 267 women in the Intervention Group and 269 women in the Control Group at post-randomization.
Total blood loss was measured in 125 women in the Intervention Group and 123 women in the Control Group at post-randomization.
Hysterectomy among women with diagnosis of uterine atony and complications of abortion.
Shock Index was calculated by (heart rate/systolic blood pressure). For each group the median and interquartile range and hazard ratio is reported. Shock Index was measured in 326 women in the Intervention Group and 358 women in the Control Group at post-randomization.
Hazard ratio.