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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
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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_MPS_07.06_eng.pdf • www.accesstohealth.org • www.venturestrategies.org • http://www.pphprevention.org/publications.php#Technical_Briefs