Research to evaluate components of AMTSL

1
Research to evaluate components of AMTSL

• POPPHI/USAID/WHO
• Istanbul, Turkey, 4-5 December 2007

2
Objective

• To determine whether the effectiveness of a
  simplified package is comparable to the full
  AMTSL package

3
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

4
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
5
Primary endpoint

• 1000 ml or more _at_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