Transcript Slide 1
Misoprostol for the Prevention of Postpartum Hemorrhage Lisa J. Thomas, MD, FACOG Women’s Commission for Refugee Women and Children Misoprostol • Background – PGE1, heat stable, inexpensive – Indications, Dosage, and Routes • Abortion, Incomplete Abortion, Induction of Labor • Prevention and Treatment of PPH – Global Burden of PPH • • • • • 25% of Maternal Deaths Worldwide 34% of Maternal Deaths in Africa (hemorrhage) Impossible to predict based on risk factors Urgent BEMOC/CEmOC Prevention is critical – AMTSL • Oxytocin is drug of choice in hospital settings • Skilled care required Growing Evidence for Effectiveness • Oral Misoprostol in preventing postpartum haemorrhage in resource-poor communities: A Randomized Controlled Trial. Derman et al, The Lancet 2006… – DB, placebo-controlled* (1620 randomized) – Miso 600 mcg po within 5 mins cord clamp/cut – Expectant management* third stage of labor – Misoprostol • Less blood loss • Less blood transfusion • Increased shivering and fever WHO Recommendations for the Prevention of PPH • “In the absence of AMTSL, a uterotonic drug (oxytocin or misprostol) should be offered by a health worker trained in its use for prevention of PPH” • Includes auxiliary nurse-midwives, community midwives, village midwives, and health visitors if they have been specially trained FIGO/ICM Call to Action – National obstetric and midwifery associations to lead efforts to implement miso/PPH – Address legislative, regulatory, and policy barriers – Call upon national regulatory agencies and policy makers to approve miso for PPH prevention and treatment Misoprostol Registration (for Prevention of PPH) • Registration gives license to market a specific product for a specific indication • Legalizes drug import and sale • Registration dossier prepared/submitted by a manufacturer/distributor pair • Decision made by country’s drug regulatory authority • Currently registered – Nigeria, India, Nepal, Bangladesh • Registration underway* – Indonesia, Egypt, Ethiopia, Tanzania, Zambia *Dossier prepared and submitted or in process Next Steps • Community Based PPH Prevention – Distribution by CHVs with client education – Invest in training and supervision – SAFE (prevent misuse) • PPH prevention as an indication for use of misoprostol on WHO essential medicines list • More research on optimal dose/route (Lower dose) Websites • http://whqlibdoc.who.int/hq/2007/WHO_M PS_07.06_eng.pdf • www.accesstohealth.org • www.venturestrategies.org • http://www.pphprevention.org/publications. php#Technical_Briefs