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. 2014 Oct 10;2014(10):CD000169. doi: 10.1002/14651858.CD000169.pub3

Ndyomugyenyi 2011 UGA.

Methods Trial design: individually RCT
Data collected: 2004 to 2008
Length of follow‐up: from first antenatal visit to 28 days after delivery
Frequency of follow‐up: regularly through ANC clinics, and every seven days postnatally
Participants Parity: all parities
Number: 5775 randomized; 4715 singleton births followed up
Inclusion criteria: pregnant women < 27 weeks at first clinic visit
Excluded: > 26 weeks pregnant, non‐residents and temporary residents
Interventions
  1. ITNs + placebo

  2. ITNS + IPT

  3. IPT


Drugs given under direct observation. Two doses of SP.
Outcomes Prevalence of maternal anaemia (Hb < 11.0 g/L)
mean Hb at 36 to 40 weeks
Clinical malaria
Peripheral and placental parasitaemia
Abortions, preterm births, stillbirths, perinatal deaths, neonatal deaths
Low birthweight
Mean birthweight
Notes Location: Kabale Highlands, Uganda
Urban/rural: rural
Malaria transmission: low/unstable area
Drug resistance: SP thought to be effective
HIV: low
Funding: Gates Partnership
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "computer‐generated random number list".
Allocation concealment (selection bias) Low risk "individual sealed envelopes".
Blinding (performance bias and detection bias) 
 All outcomes Low risk "Tablets of SP or placebo, identical in shape and colour".
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk "All study participants, health staff and researchers were blind to drug assignment (SP or placebo)".
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Delivery follow‐up: 92%, 92%, and 93% to one month.
Selective reporting (reporting bias) Low risk No evidence of selective reporting.
Other bias Low risk None identified.