UK 1991b.
Methods | A double‐blind, RCT. | |
Participants | 152 women resident in Scunthorpe Health District who booked for care before the 18th week of gestation, and who were booked for delivery at either Scunthorpe Maternity Home or at Scunthorpe General Hospital, were recruited for the study. 134 women completed the trial. | |
Interventions | Women were randomly assigned to 2 groups, X and Y. The the supplements were prepared by Smith Kline and French. The spansules contained 150 mg of FeSO4 and 0‐5 mg of folic acid for Group X. For Group Y, 62 mg of zinc sulphide was added to the 150 mg of FeSO4 and 0‐5 mg of folic acid . Participants were asked to take 1 spansule per day. Haematological tests were undertaken on entering the study and at the 28th week of gestation. Group X: iron + folic acid (n = 62). Group Y: iron + folic and zinc: (n = 72). | |
Outcomes | Low birthweight < 2500 g;
birthweight > 3500 g; congenital malformations; stillbirth/neonatal death. |
|
Notes | Adherence was not reported. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "double blind." |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Losses to follow‐up: 18/152 (12%) due to GI effects, aborted or woman moved, leaving 72 in the zinc group and 62 in the control group. |
Selective reporting (reporting bias) | High risk | No maternal outcomes reported. |
Other bias | Low risk | No apparent risk of other bias. |