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

Menendez 1994 GMB.

Methods Trial design: Cluster‐RCT
Data collected: 1987 to 1990
Length of follow‐up: from first antenatal visit to third day after delivery
Frequency of follow‐up: unclear but administration by traditional birth attendants was on weekly basis
Participants Parity: 0
Number: 230
Inclusion criteria: primigravidae resident in trial area
Excluded: none stated
Interventions

  1. Pyrimethamine and dapsone: weekly (one tablet of Maloprim weekly: pyrimethamine 12.5 mg and dapsone 100 mg)

  2. Placebo


Given by village people employed by the project
Other: no information
Administration supervised: yes
Outcomes

  1. Placental malaria

  2. Pregnancy outcomes

  3. Birthweight

  4. Neonatal mortality
Notes Location: The Gambia
Urban/rural: rural (trial area: 15 villages and 3 hamlets, 12 to 35 km from the town of Farafenni)
Malaria transmission: seasonal
HIV: no information provided
Drug resistance: none reported
Funding: no information
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Described as "a randomized, double‐blind, placebo‐controlled community based trial" but no details of the way allocation sequence was generated are provided.
Allocation concealment (selection bias) Unclear risk "After consent had been obtained, women were randomized by compound of residence to receive weekly either one tablet of Maloprim or placebo."
Comment: insufficient detail.
Blinding (performance bias and detection bias) 
 All outcomes High risk Not blinded.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No information provided.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Unclear.
"Two hundred and thirty women were recruited into the study over a 3‐year period…"
Afterwards, only 82 women are mentioned as participants in the maloprim group and 89 women in the placebo group. Overall attrition rate 59/230 (25.7%)
The total number of women with incomplete outcome data 28/230 (12.2%). Four women had an abortion, 17 had stillbirths, five women died, and 2 other women (0.9%) were lost to follow‐up.
Selective reporting (reporting bias) Low risk No selective reporting observed.
Other bias Low risk No other source of bias identified.