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

Mbaye 2006 GMB.

Methods Trial design: RCT
Data collected: 2002 to 2004
Length of follow‐up: From the 1st antenatal visit to 1 year after delivery
Frequency of follow‐up: twice per week before delivery; 6 weeks and 1 year after delivery
Participants Parity: multigravidae only
Number: 2688
Inclusion criteria: pregnancy of more than 15 weeks duration
Excluded: Hb concentration of < 7 g/dL; allergy to sulphonamides; severe or chronic disease
Interventions

  1. 3 tablets of SP (up to 4 drug administrations; mean gap 29 days)

  2. 3 tablets of placebo (up to 4 administrations; mean gap 28 days)


Other: iron and folic acid for all
Administration supervised: yes
Outcomes

  1. Maternal mortality

  2. Prevalence of peripheral parasitaemia after delivery

  3. Anaemia/Hb

  4. Birth outcomes

  5. Infant death (death by 6 weeks)
Notes Location: The Gambia
Urban/rural: urban (around the town Farafenni)
Malaria transmission: seasonal
Drug resistance: unknown
HIV: HIV negative women; prevalence of HIV infection among antenatal clinic attenders < 1%
Funding: The Medical Research Council and the Gates Malaria Partnership, funded by the Bill and Melinda Gates foundation
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Women were individually randomized in blocks of 12".
Allocation concealment (selection bias) Low risk "Tablets were pre‐packed in envelopes…pre‐labelled with the same packet number and placed in a wallet bearing the subject’s number and packet number."
Blinding (performance bias and detection bias) 
 All outcomes Low risk Identical SP and placebo tablets used.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No information provided.
Incomplete outcome data (attrition bias) 
 All outcomes High risk Attrition rate quite high: 459/2688 (17.1 %): Loss to follow‐up in SP group 223/1346 (16.6%) and in the placebo group 236/1342 (17.6%).
Selective reporting (reporting bias) Low risk No apparent risk.
Other bias Unclear risk Limited information obtained on bednet use (an important variable in determining the efficacy of IPT). Actual birthweights obtained from only 5% of women (87% of the newborn babies were weighed between 3 and 5 days after birth).