News Release

Misoprostol plus oxytocin no better than oxytocin alone at preventing blood loss post-birth

WHO criticized for withdrawing support for misoprostol in low-income settings

Peer-Reviewed Publication

The Lancet_DELETED

An Article in this week's Lancet shows that in various middle-income (and low-income) countries, misoprostol plus standard uterotonics (mainly oxytocin) is no better than uterotonics alone at preventing post-birth (post-partum) blood loss. However, an accompanying Comment criticises WHO for withdrawing support for use of misoprostol in low-income countries where there are no other options, and says the issue needs to be urgently resolved. The Article is by Dr Mariana Widmer, Department of Reproductive Health and Research, WHO, Geneva, Switzerland; Dr Jennifer Blum, Gynuity Health Projects, New York, USA; and Dr G Justus Hofmeyr, Eastern Cape Department of Health and Universities of the Witwatersand and Fort Hare, South Africa, and colleagues.

Evidence for use of misoprostol for post-partum haemorrhage has so far been inconclusive. In this study, the authors aimed to establish whether further blood loss could be reduced with the addition of 600 μg misoprostol orally to standard uterotonic treatment (mostly oxytocin) in women with post-partum haemorrhage that was suspected to be caused by uterine atony (loss of muscle tone) in vaginal delivery. Normally contraction of the uterine muscle restricts blood flow and prevents bleeds, thus loss of muscle tone can lead to bleeds.

In this randomised study, women delivering vaginally who had clinically diagnosed post-partum haemorrhage due to uterine atony were enrolled from participating hospitals in Argentina, Egypt, South Africa, Thailand, and Vietnam between July, 2005, and August, 2008. Women were randomised to receive 600 μg misoprostol or matching placebo orally; both groups were also given routine injectable uterotonics (mainly oxytocin). The primary outcome was blood loss of 500 mL or more within 60 min after randomisation. 1422 women were assigned to receive misoprostol (n=705) or placebo (n=717). The proportion of women with blood loss of 500 mL or more within 60 min was similar between the misoprostol group (14%) and the placebo group (14%). In the first 60 min, an increased proportion of women on misoprostol versus placebo had shivering (65% vs 32%); and body temperature of 38°C or higher (43% vs 15%).

The authors say: "The results of this large trial show no benefit of misoprostol in addition to standard injectable uterotonics for the treatment of post-partum haemorrhage. Moreover, misoprostol use was associated with shivering, body temperature of 38°C or higher, and vomiting... Any further research on misoprostol should focus on the possible effectiveness of misoprostol in settings where standard uterotonics are not available."

In the companying Comment, Dr Malcolm Potts and Dr Ndola Prata, Bixby Center for Population, Health and Sustainability, University of California, Berkeley, Berkeley, CA and Dr Nuriye Nalan Sahin-Hodoglugi, Venture Strategies Innovations, Anaheim, CA, USA, discuss WHO's withdrawal of support of use of misoprostol use when there is no other option, namely in resource-limited settings. They highlight that in 2006, a WHO expert meeting recommended that "auxiliary nurse-midwives, community midwives, village midwives and health visitors…if they have beenspecially trained" can distribute misoprostol. However, in 2009, WHO's Department of Making Pregnancy Safer issued a statement saying "WHO does not recommend distribution of misoprostol to community level health workers or women and their families for routine or emergency use". However, the International Federation of Gynecology and Obstetrics (FIGO) and the International Confederation of Midwives agreed that "in home births without a skilled attendant, misoprostol may be the only technology available to control [post-partum haemorrhage]".

Potts and colleagues say: "WHO's policy reversal is causing confusion and the need for consensus is urgent... Without widespread community use of misoprostol, it is unlikely that Millennium Development Goal 5 will be achieved in sub-Saharan Africa... last year's WHO statement on the use of misoprostol in the community put the brake on what some consider potentially life-saving work."

They conclude: "We suggest that WHO and FIGO call a joint emergency meeting to explore whether that brake needs to be applied or released."

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Dr Mariana Widmer, Department of Reproductive Health and Research, WHO, Geneva, Switzerland. T) +41 227914323 E) widmerm@who.int

Dr Jennifer Blum, Gynuity Health Projects, New York, USA. T) +1 212-448-1230 E) jblum@gynuity.org

Dr G Justus Hofmeyr, Eastern Cape Department of Health and Universities of the Witwatersand and Fort Hare, South Africa. T) +27 83 2809402 E) justhof@gmail.com

Dr Malcolm Potts, Bixby Center for Population, Health and Sustainability, University of California, Berkeley, Berkeley, CA, USA. T) +1 510 524 4320 / +1 510 375 6226 E) potts@berkeley.edu

Dr Ndola Prata (alternative Comment author) , Bixby Center for Population, Health and Sustainability, University of California, Berkeley, Berkeley, CA, USA. T) +1 925 639 2842 E) ndola@berkeley.edu (note from Comment authors—Dr Prata is African and has conceptualised many studies on this issue)

For full Article and Comment see: http://press.thelancet.com/whomisoprost.pdf


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