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

Shulman 1999 KEN.

Methods Trial design: RCT
Data collected: 1996 to 1997
Length of follow‐up: from first antenatal visit to one month post delivery (neonatal period)
Frequency of follow‐up: unclear (drug administered as follows: three doses for women recruited at 16 to 19 weeks of gestation; two for those recruited at 20 to 26 weeks; and one for those recruited at 27 to 30 weeks, followed by a visit at 34 weeks and a visit 4 weeks after delivery).
Participants Parity: 0
Number: 1264
Inclusion criteria: primigravidae attending antenatal clinics at a health centre (1) or hospital (1); singleton pregnancy; 16 to 30 weeks gestation
Excluded: severely anaemic and sick patients excluded
Interventions
  1. SP: recruited at 16 to 19 weeks (2 doses); 20 to 26 weeks (2 doses); 27 to 30 weeks (1 dose)

  2. Placebo


Other: ferrous sulphate; impregnated bed nets in use in the area
Administration supervised: yes
Outcomes
  1. Antenatal: parasitaemia and haemoglobin at 34 weeks

  2. Stillbirth

  3. Neonatal death

  4. Maternal death

  5. Morbidity

Notes Location: Kenya
Urban/rural: rural (Kilifi)
Malaria transmission: hyperendemic and mesoendemic areas
Drug resistance: present
Funding: UK Department for International Development and KEMRI
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Participants were assigned unique identification numbers sequentially… identification numbers had been randomly allocated to a number between zero and nine, in blocks of ten."
Comment: randomization method, using permuted blocks
Allocation concealment (selection bias) Low risk Drugs supplied in bottles.
"Questionnaires were premarked with this unique identification number and the bottle number. The code relating bottle numbers to their contents was retained by a statistician and clinician, not involved in the study."
Comment: allocation concealed.
Blinding (performance bias and detection bias) 
 All outcomes Low risk SP and placebo tablets, "identical in appearance and taste".
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not clear whether outcome assessors were blinded.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Attrition rate 11.41% (73/640) in the SP group and 9.5 % (59/624) in the placebo group, signifying the number of women with no blood test during third trimester.
Selective reporting (reporting bias) Low risk Trial protocol available; no apparent risk of selective reporting identified.
Other bias Unclear risk Protocol violation: 6 women from SP group and 8 from placebo group reported taking extra doses of SP (unclear whether women from the placebo group took placebo tablets, or real SP).
69 women from SP group reported taking chloroquine.
61 women from placebo group reported taking chloroquine.