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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_M
PS_07.06_eng.pdf
• www.accesstohealth.org
• www.venturestrategies.org
• http://www.pphprevention.org/publications.
php#Technical_Briefs