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