Misoprostol for the Prevention of Postpartum Hemorrhage Lisa J. Thomas, MD, FACOG Women’s...

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