From: Misoprostol for treating postpartum haemorrhage: a randomized controlled trial [ISRCTN72263357]
Misoprostol (117) | Placebo (121) | |||||
---|---|---|---|---|---|---|
Baseline characteristics | n | n | ||||
Age (years) | 116 | 27.1 [6.0] | 119 | 26.2 [6.2] | ||
Ergometrine before enrolment | 106 | 36 (34%) | 104 | 34 (33%) | ||
Oxytocin ≥20 U before enrolment | 116 | 82 (71%) | 117 | 78 (67%) | ||
Primary outcomes: | RR/ MD | 95% Conf. interval | ||||
Blood loss ≥500 ml* | 117 | 6 (5.1%) | 120 | 11 (9.2%) | 0.56 | 0.21 to 1.46 |
Mean blood loss* [SD] (ml) | 117 | 168 [163] | 120 | 176 [173] | -8 | -51 to 35 |
24 hour Haemoglobin <6 g/dL or blood transfusion | 110 | 20 (18.2%) | 116 | 17 (14.7%) | 1.24 | 0.69 to 2.24 |
Pyrexia at 1 hour ≥38, 5°C | 114 | 11 (9.6%) | 118 | 2 (1.7%) | 5.69 | 1.29 to 25 |
Shivering at 1 hour ≥ moderate | 116 | 63 (54%) | 118 | 30 (25%) | 2.14 | 1.50 to 3.04 |
Secondary outcomes: | ||||||
Blood loss ≥ 1,000 ml* | 117 | 1 (0.85%) | 120 | 0 (0%) | ||
Blood transfusion | 115 | 19 (17%) | 119 | 15 (13%) | 1.31 | 0.70 to 2.45 |
24 hour haemoglobin <8 g/dL or blood transfusion | 110 | 43 (39%) | 116 | 37 (32%) | 1.23 | 0.86 to 1.75 |
Additional uterotonic after enrolment | 111 | 63 (57%) | 112 | 63 (56%) | 1.01 | 0.80 to 1.27 |
Manual removal of the placenta | 117 | 1 (0.85%) | 121 | 4 (3.3%) | 0.26 | 0.03 to 2.28 |
Evacuation of retained products of conception | 117 | 2 (1.7%) | 121 | 0 (0%) | ||
Hysterectomy** | 117 | 3 (2.6%) | 121 | 0 (0%) | ||
Maternal death** | 117 | 3 (2.6%) | 121 | 0 (0%) |