China 2001.
Study characteristics | ||
Methods | A double‐blind, randomised, placebo‐controlled four‐armed trial | |
Participants | 146 pregnant women, less than 12 weeks' gestation, who were living in southwest Shanghai, Maqiao countryside and were attending the prenatal clinic at Maqiao Primary Health Care Center were selected for the study The people living in this area were uneducated with nutritional knowledge, and took cereal‐based diet with a little or even no milk or milk products; they were therefore presumed to have mild‐to‐moderate zinc deficiency according to Chinese recommended dietary allowance. The zinc content of drinking water in this area was considered negligible and no women received folic acid, iron supplementation or any commercial nutrition products during this trial |
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Interventions | For the zinc treatment groups, zinc lactate in capsule were given daily.
All capsules were prepared by Laboratory, Second Military Medical University with indistinguishable appearance. Women were instructed to take a single capsule per day 1 hour before or 3 hours after the evening meal. The content of the capsules and the code of the capsule bottles were not known by the investigator or the pregnant women. Only 156 women were followed up under antenatal care |
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Outcomes | For the purposes of this review, Group A, B and C were combined as an intervention group and Group D served as a control group Maternal outcomes Caesarean section Weight gain Duration of labour Oxygen demand Forceps Neonatal outcomes Small‐for‐gestational age/Intrauterine growth restriction Gestational age at birth Neonatal sepsis Low birthweight Congenital malformation Stillbirth Preterm birth Apgar score Chest circumference Neck circumference Head circumference Crown‐heel length Ponderal index |
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Notes | Dates of study: September 1995 ‐ December 1997 Funding sources: not disclosed Declarations of interest: not disclosed |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No description other than the allocation was made randomly |
Allocation concealment (selection bias) | Low risk | All capsules were prepared by pharmacy and allocation was concealed for both investigators and women |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | All capsules were prepared by pharmacy and both investigators and enrolled pregnant women were concealed |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No description |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts for maternal and neonatal clinical outcomes reported |
Selective reporting (reporting bias) | Unclear risk | There is no information on protocol published prior to this trial and no information to make appropriate judgements on this |
Other bias | Unclear risk | It was reported that obstetric and physical background data between the groups were not significantly different, although actual data were not reported |