Hamer 2007.
| Methods | Design: RCT | |
| Participants | Number: 456 were enrolled Inclusion Criteria: HIV positive women of any gravidity Exclusion criteria: prior adverse reaction to sulfa‐containing drugs and women aged <18 years |
|
| Interventions | 1. Monthly intermittent preventive treatment using sulphadoxine‐pyrimethamine 2. Control: 2 doses of sulphadoxine‐pyrimethamine, one in 2nd trimester and the other in 3rd trimester |
|
| Outcomes | 1. Placental malaria (by histology)
2. Placental parasitaemia
3. Peripheral parasitaemia
4. Placental malaria
5. Maternal anaemia at delivery
6. LBW
7. ADR Not included in this review 1. Gestational age 2. Uncomplicated malaria 3. Cord blood parasitaemia |
|
| Notes | Location: Zambia Date: 2003 ‐ 4 Funding: Cooperative Agreement No. S1954‐21/21 |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Generation of allocation sequence: randomization was done in blocks of 20 |
| Allocation concealment (selection bias) | Low risk | Allocation concealment: participants were assigned sequential ID numbers corresponding to a sealed package of trial drugs whilst randomization codes were retained in the USA |
| Blinding (performance bias and detection bias) Clinicians | Low risk | Investigators were blinded. |
| Blinding (performance bias and detection bias) Patients | Low risk | Trial participants were blinded. |
| Blinding (performance bias and detection bias) Technicians | Low risk | Laboratory/ pathologists were all blinded |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Inclusion of randomized participants in the analysis: participants with data available were analyzed and not everyone randomised |
| Selective reporting (reporting bias) | Low risk | All outcomes are included in the results section. |
| Other bias | Low risk | No other biases suspected. |
RCT = Randomized Controlled Trial HIV = Human Immonodeficiency Virus ADR = Adverse Drug Reactions CDC = Centers for Disease Control WHO = World Health Organization LBW = Low Birth Weight