Bulletin of the World Health Organization

Misoprostol to prevent and treat postpartum haemorrhage: a systematic review and meta-analysis of maternal deaths and dose-related effects

G Justus Hofmeyr, A Metin Gülmezoglu, Natalia Novikova, Verena Linder, Sandra Ferreira & Gilda Piaggio

Volume 87, Number 9, September 2009, 666-677

Table 2. Maternal deaths and severe morbidity reported in randomized controlled trials of misoprostol to prevent or treat postpartum haemorrhage

Studya Misoprostol group Control group
China 2001: 600 PO vs U31 No cases 1 hysterectomy in multiparous woman with PPH (5 L) due to uterine atony
China 2004a: 600 PO vs U32 PPH (4 L) due to uterine atony in primiparous woman No cases
Gambia 200437: 600 PO/SL vs P No cases 2 hysterectomies, no details reported
Gambia 200538: 600 PO vs P 1 maternal death from PPH (2.2 L) in gravida 7, para 6, delivered at home 1 hospital admission for PPH and clinical anaemia
1 maternal death from disseminated intravascular coagulation due to malaria 2 hospital admissions for severe postpartum anaemia
2 hospital admissions from severe postpartum anaemia
Guinea-Bissau 200514,41: 600 SL vs P 1 maternal death, PPH (1.4 L), cause of death not established on autopsy No cases
India 2006c46: 600 PO vs P 2 ICU admissions 2 ICU admissions
South Africa 2001a55: 600 PO vs P 1 case of fever > 40 °C No cases
South Africa 2001b57: 80 PO vs U 1 internal iliac artery ligation for severe PPH 1 hysterectomy for severe PPH
South Africa 200458: 1000 PO/SL/PR vs P 1 maternal death from severe PPH, coagulopathy, had hysterectomy, died on day 2 postpartum No cases
1 maternal death from severe PPH (3 L) secondary to cervical tear, coagulopathy
1 maternal death from PPH (1 L), hypotension and cardiac arrest, possibly had internal bleeding from dehisced Caesarean section scar
2 hysterectomies for PPH
WHO 200169,70: 600 PO vs U 2 maternal deaths 2 maternal deaths
4 hysterectomies 8 hysterectomies
4 ICU admissions 5 ICU admissions
5 cases of fever > 40 °C

ICU, intensive care unit; IV, intravascular; PPH, postpartum haemorrhage.
a The format used for study identifiers was as follows: country, year, misoprostol (M) dose in micrograms (µ), route of administration (IM = intramuscular; IV = intravenous; PO = oral; PR = rectal; SL = sublingual), misoprostol compared with (vs) placebo (P) or another uterotonic (U).