Table 1.
Previous trials investigating health outcomes of prophylactic iron supplementation during pregnancy, endemic malaria areas and non‐malarial areas, developing countries
| Author, year of publication (Reference number) | Country | Allocation | Intervention* (n) ‡‡‡ | Control † (n) ‡‡‡ | N ‡ | Start | Population | Results §¶ | Potential problems |
|---|---|---|---|---|---|---|---|---|---|
| Malarial area | |||||||||
| Fleming et al. 1986, ** | Nigeria | RCT | 60 mg iron; 60 mg + 1 mg folate (40) | Placebo; 600 mg chloroquine + 100 mg proguanil (42) | 200 | <24 weeks | 1st pregnancy | No significant effect of iron found. | Compliance was poor; high dropout rates, and exclusions by outcomes |
| Menendez et al. 1994, †† | The Gambia | RCT | 60 mg iron + 1 mg folate (273) | Placebo + 1 mg folate (277) | 757 | <34th week | More than 1 pregnancy | ▴BW | Outcome‐related exclusions 27% (e.g. preterm births, women developing anaemia) |
| Preziosi et al. 1997, ‡‡ | Niger | RCT | 100 mg iron (99) | Placebo (98) | 197 | Mean 28 week (SD 3 weeks) | Healthy women, 66% anemic | ▴BL; ▴AS | Small trial |
| Ndyomugyenyi & Magnussen 2000, §§ | Uganda | RCT | 120 mg iron + 5 mg folate (174) | Placebo (168) | 576 | <28 week | 1st pregnancy, Hb ≥80 g L−1 | ▴BW | Outcome‐related exclusions (women developing anaemia, late baby weighing); many lost to follow‐up |
| APHA, Atlanta, 2001 (T. Juncker et al., unpublished observations) ¶¶ | Bangladesh | Alternative | 66 mg Iron + 250 μg folate (772) | Vitamin B (812) | 2007 | ≥24 week | ≥9.0 g/dL Hb at recruitment | ▴PD; ▾BW | Only extended abstract available |
| Non‐malarial area | |||||||||
| Zeng et al. 2008, *** | China | Cluster RCT | 60 mg iron + 400 μg folate (1565) | 400 μg folate (1705) | 3929 | <28 week | Early pregnancy <28 weeks | ▴GA; ▾PD; ▾MA; ▴BL | Outcome‐related exclusions 20–26% (withdrawal due to nausea and vomiting, foetal loss, and other medical conditions) |
| Christian et al. 2003a,2003b, 2008, 2009a,b, 2010 ††† | Nepal | Cluster RCT | 60 mg iron + 400 μg folate (635) | Vitamin A, 1000 μg (628) | 2008 | Mean 11 week (SD 5.1 weeks) | Recent pregnancy | ▾IH; ▾PS; ▾LBW; ▾IM; ▾CM; ▴BW; ▴ IF; ▴MF | >90% of births happened at home; large numbers of dropouts for most outcomes and reduced number at follow‐ups |
A, abortion; AH, antepartum haemorrhage; ALRI, acute lower respiratory infections; AS, Apgar score; B, bacteriuria; BA, birth asphyxia; BW, birthweight; BL, birth length; CC, chest circumference; CM, child mortality; D, diarrhoea; DL, dysfunctional labour; E, pre‐/eclampsia; FL, foetal loss; GA, gestational age; HC, head circumference; IF, intellectual functioning; IH, intrapartum haemorrhage; IM, 3‐month infant mortality; LBW, low birthweight; M, malaria; MD, mode of delivery; MF, motor functioning; MH, maternal hypertension; MI, maternal infection; ND, neonatal death; O, ophathalmia; P, pyrexia; PD, preterm delivery; PH, post‐partum haemorrhage; PS, puerperal sepsis; PVT, positive venereal disease research laboratory test; PW, placenta weight; RM, preterm premature rupture of membrane; SA, skin abscess; SB, stillbirth; SGA, small‐for‐gestational age; SS, skin sepsis; UCN, umbilical cord around the neck. *If several intervention groups, only the iron or iron‐folate group is presented. †The control group is a placebo or control alternative that excludes iron. ‡Total number of subjects randomised in both iron and control groups. §Comparing the intervention group with the control group. Only results that achieved statistical significance (as reported by the authors) are presented. ¶Symbols: (▴) increase; (▾) decrease. **Outcome assessed: A, ALRI, AS, B, BA, BW, CM, D, E, FL, GA, IH, MD, MH, ND, P, PH, PVT, SA and UCN. ††Outcome assessed: BW, LBW and M. ‡‡Outcome assessed: AS, BW, BL and PW. §§Outcome assessed: BW. ¶¶Outcome assessed: AH, BW, LBW, MH, MI, ND PD and SB. ***Outcome assessed: BW, BL, GA, HC, LBW, PD and SGA. †††Outcome assessed: ALRI, BA, BL, BW, CC, CM, DL, FL, H, HC, IF, IH, IM, LBW, MF, PD, PS, RM and SGA. ‡‡‡Number analysed.