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. 2015 Oct 19;2015(10):CD009997. doi: 10.1002/14651858.CD009997.pub2

Robinson 1999.

Methods RCT. 3 arms.
Participants 580 pregnant women served by 11 health centres from 5 sub‐districts on or near the western end of the island of Seram in the Province of Maluku, Indonesia between October 1996 and September 1997.
Interventions Participants were assigned to 1 of 3 interventions: group 1 (n = 200) received 60 mg of elemental iron (as ferrous sulphate) with 250 μg (0.25 mg) of folic acid daily by a traditional birth attendant; group 2 (n = 199) received 120 mg of elemental iron (as ferrous sulphate) with 500 μg (0.5 mg) of folic acid once a wk (two tablets) by the traditional home visiting birth attendants group 3 (n = 181) control group was formed by participants receiving traditional iron supplements (60 mg elemental iron) with folic acid from health centres in a usual manner, self‐administered without incentive.
Each of the group was further assigned alternatively by registration number to receive 500 mg of mebendazole or a placebo at the second trimester of pregnancy.
Setting and health worker cadre: the intervention was performed by traditional birth attendants in villages greater than 10 km from a health centre in Maluku, Indonesia.
Outcomes Maternal: Hb concentration at baseline and after 12 and 20 wks of supplementation; serum ferritin at baseline and after 12 wks of supplementation; compliance.
Laboratory method for ferritin concentration: not reported.
Notes Daily group and control unsupervised. Weekly group supervised.
 Only groups 1 and 2 are used in this analysis. Compliance was 69.6%, 96.2% and 46.9% for groups 1, 2 and control respectively. The study area is endemic to malaria.
1. By gestational age at start of supplementation: unspecified gestational age or mixed gestational ages at the start of supplementation.
2. By anaemia status at baseline: unspecified/mixed anaemia status at start of supplementation.
3. By weekly iron dose in the group receiving intermittent supplementation: low weekly dose of iron in the intermittent group (120 mg elemental iron or less per wk).
4. By release speed of iron supplements: not specified/unreported/unknown.
5. By bioavailability of the iron compound relative to ferrous sulphate: equivalent or lower: ferrous sulphate.
6. By intermittent iron supplementation regimen: once a wk.
7. By malaria endemicity of the area in which the trial was conducted: not specified/unreported/unknown. As of 2011: malaria risk exists throughout the year in all areas of the 5 eastern provinces of East Nusa Tenggara, Maluku, North Maluku, Papua and West Papua. In other parts of the country, there is malaria risk in some districts, except in Jakarta Municipality and in big cities.
Source of funding: World Health Organization, Geneva, Switzerland.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described.
Allocation concealment (selection bias) Unclear risk Not described.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Different regimens compared. Women and staff would be aware of treatment allocation. Supplements distributed by traditional birth attendants.
Blinding of outcome assessment (detection bias) 
 Laboratory outcomes Low risk Laboratory outcomes were unlikely to have been affected by lack of blinding.
Blinding of outcome assessment (detection bias) 
 Side effects and compliance High risk Compliance may have been affected by lack of blinding.
Incomplete outcome data (attrition bias) 
 All outcomes High risk More than 20% lost to follow‐up and missing data for some outcomes. "Women with missing or bizarre data were not included in the analysis. In addition, women who did not carry their pregnancy the whole study period... were not included."
Selective reporting (reporting bias) Unclear risk There is insufficient information to permit judgement.
Other bias High risk The study was a follow‐up of a previous study that included 200 women who were either receiving daily iron supplements distributed by traditional birth attendants and 100 women receiving usual care as of Ministry of Health provides in this country. Several months after the study was initiated, the daily group was further divided into daily or weekly regimens. The methodologies for assessing Hb and ferritin were also changed during the course of the study. The sample size also increased after the study design was changed.