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Published byArchibald Webb Modified over 9 years ago
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Research to evaluate components of AMTSL POPPHI/USAID/WHO Istanbul, Turkey, 4-5 December 2007
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Objective To determine whether the effectiveness of a simplified package is comparable to the full AMTSL package
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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
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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
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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
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Design Individually randomized trial Non-inferiority hypothesis Target sample size: 25,000 Eight countries –Argentina, Egypt, India, Kenya, Philippines, South Africa, Thailand, Uganda
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