Rethinking WHO Guidance

Abstract

I write due to concern that persons who wish to restrict misoprostol use, because of personal biases against termination of pregnancy, might attempt to use the article by Chu, Brhlikova, and Pollock to influence policy. The safety and efficacy of misoprostol has been demonstrated in hospital settings, and does not merit debate. The authors review only four studies of misoprostol use in community and home births. Studies of community and home births are difficult, comparison with placebo is deemed unethical by many, and blinding of misoprostol use is essentially impossible due to the shivering. The one study, by Hoj, which utilized a placebo found a significant difference in severe blood loss, the outcome (other than death) which is most critical. The authors attempt to discredit studies due to exclusion of high risk patients. The exclusion criteria listed for the Mobeen study include planning not to deliver at the birth center, previous Cesarean section, and ‘unlikely to deliver vaginally’, conditions which would appropriately and ethically mandate referral for hospital delivery. The excluded women would be at increased risk of uterine rupture, which is not primarily treated with uterotonics. They note that Mobeen's study shows that PPH rates in both groups decreased as the study progressed, and hypothesized this was due to later-recruited midwives being more skilled. This supports the use of misoprostol by less-skilled birth attendants, rather than not using it at all, if one wants to decrease PPH. Oxytocin alone does not always work, whether for induction of labor or prevention or treatment of hemorrhage. Those of us who attend births in the developed world often use misoprostol in addition to oxytocin. I would hate to have misoprostol withdrawn from my pharmacopeia in the USA. The issue is not whether WHO should keep misoprostol on the essential drug list, but rather who should be allowed access to misoprostol, which is an issue that each nation should decide, depending on its own national needs and priorities.