Farren 2017.
Study characteristics | ||
Methods | Study type: single‐centre, parallel RCT | |
Participants | 240 pregnant women from Ireland Inclusion criteria: women were 10 to 16 weeks' gestation at trial entry. Pregnant women with a family history in a first‐degree relative of diabetes, either type 1 or type 2, were eligible for inclusion. Exclusion criteria: age younger than 18 years, multiple pregnancies, limited comprehension of English, and any pre‐existing liver or kidney disease or diabetes. Timeframe: January 2014 to January 2016 |
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Interventions |
Intervention: combination of myo‐inositol 1,100mg, C‐chiro‐inositol 27.6mg, and 400 microgram folic acid daily (N = 120) Duration of myo‐inositol supplementation; not stated Comparison: 400 microgram folic acid daily (N = 120) |
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Outcomes |
Maternal: occurrence of gestational diabetes, gestational hypertension, induction of labour, the mode of delivery, perineal trauma Criteria used to diagnose GDM: IADPSG Infant: birth weight, shoulder dystocia, brachial plexus palsy, neonatal intensive care unit (NICU) admission, neonatal hypoglycaemia, respiratory distress syndrome Further information was received following email contact with the authors. |
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Notes |
Sample size calculation: yes Intention‐to‐treat analysis: yes Induction of labour was not reported in the study. Funding source: supported by the Coombe Women & Infants University Hospital. The food supplement was provided at no cost from Lo.Li. Pharma. Conflicts of interest: none reported Ethical approval was granted by the Hospital Research Ethics Committee in June 2013. The trial was registered with the ISRCTN registry and assigned the trial number ISRCTN92466608. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was carried out by an independent statistician. |
Allocation concealment (selection bias) | Low risk | The author confirmed that they used sealed opaque and sequentially numbered envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The Investigators knew which supplement was dispensed and the women knew which supplement they were taking, but the clinicians managing the pregnancy and delivery were blinded. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Trial was open label, investigators were aware of which supplement was dispensed. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The authors provide a list of the flow of participants through their trial. |
Selective reporting (reporting bias) | Low risk | All collected outcomes have been reported. |
Other bias | Low risk | Authors had no potential conflicts of interest related to the article. |