Transcript Technical Consultation to discuss the research to evaluate

Research to evaluate
components of AMTSL
POPPHI/USAID/WHO
Istanbul, Turkey, 4-5 December
2007
Objective
• To determine whether the effectiveness of
a simplified package is comparable to the
full AMTSL package
Working definition of AMTSL
• Oxytocin 10IU in uniject im immediately after the
birth of the baby (preferably within 1 minute)
• Palpate the uterus to see when uterus contracts
• Once the uterus contracts clamp and cut the
cord (at around 3 minutes)
• Apply controlled cord traction immediately after
cord clamping
• If the cord has been clamped early because of
newborn indication apply cord traction only after
uterus has contracted
• Uterine massage: FIGO/ICM
Interventions
• Full AMTSL package (according to the
working definition)
Versus
• Simplified package (uterotonic)
– Placental delivery with maternal effort
– Massage after delivery (if practiced at the
facility)
Cord management: clamp at around 3 minutes in all women
Primary endpoint
• 1000 ml or more @One hour
• Blood loss of 1000 ml or more for
minimum 1 hour and up to 2 hours for
women who continue to bleed
Design
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Individually randomized trial
Non-inferiority hypothesis
Target sample size: 25,000
Eight countries
– Argentina, Egypt, India, Kenya, Philippines,
South Africa, Thailand, Uganda