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

Menendez 2008 MOZ.

Methods Trial design: RCT
Data collected: August 2003 to April 2005
Length of follow‐up: from recruitment until 8 weeks postpartum
Frequency of follow‐up: unclear. Mean number of outpatient visits during pregnancy 1.64 in the SP and 1.83 in the placebo group. Mean number of visits post‐partum 0.69 in the SP group and 0.68 in the placebo group
Participants Parity: all
Number: 1030
Inclusion criteria: permanent residents of the CISM trial area with gestational age ≤ 28 weeks
Excluded: allergic to sulpha drugs
Interventions
  1. Two doses of SP given at least one month apart

  2. Placebo ‐ same


Other: ITNs
Administration supervised: yes
Outcomes
  1. Maternal mortality

  2. Peripheral parasitaemia

  3. Any placental malaria infection (fever episode)

  4. Severe anaemia (PCV < 21%)

  5. Pregnancy outcomes

  6. Perinatal mortality

  7. Neonatal mortality

  8. Birthweight

  9. Pre‐term birth

  10. Cord blood parasitaemia

  11. Cord blood anaemia (PCV < 37%)

  12. Newborn gestational age

Notes Location: Mozambique
Urban/rural: urban
Malaria transmission: perennial malaria transmission with some seasonality
Drug resistance: evidence suggests that SP was highly effective in the area during the trial
HIV: In the SP group, 26.5% (117/441 women), and in the placebo group, 21.2% (91/429 women). Overall: 23.9%
Funding: Fondo de Investigaciones Sanitarias del Instituto de Salud Carlos III (grant number CM03/00125); Banco de Bilbao, Vizcaya, Argentaria Foundation (grant number BBVA 02‐0); Spanish Agency for International Cooperation (AECI)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "A computer‐generated sequential list contained the study numbers linked to treatment identification letters, randomly ordered in blocks of 10".
Allocation concealment (selection bias) Low risk "Tablets of SP or placebo... were stored in 10 bottles labelled only with a single treatment identification letter."
Blinding (performance bias and detection bias) 
 All outcomes Low risk SP and placebo tablets "identical in shape and colour".
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No details provided.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk In the SP group 35/515 (6.8%) did not receive 2 doses and birthweight was not measured for 7/501 (1.4%) live births. In the placebo group 29/515 (5.6%) did not receive 2 doses and birthweight was not measured for 7/503 (1.4%) live births.
Selective reporting (reporting bias) Low risk None identified (trial protocol available).
Other bias Unclear risk Data were analysed by ITT analysis whereby all randomized women were included regardless of whether or not they had received the intervention and the number of doses. Women with a multiple delivery (twins or triplets) as well as those who did not receive all three doses were also included in the analysis.