Popova 2018.
| Study characteristics | ||
| Methods | Randomised controlled trial | |
| Participants | Women were included if they were in the 8th to 31st week of gestation and met the World Health Organization criteria for GDM (WHO 2013). GDM1 n = 201, GDM2 n = 194 Exclusion criteria: nil reported Setting: Almazov National Medical Research Centre (Saint Petersburg, Russian Federation) |
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| Interventions | GDM1/very tight glycaemic targets: FBG < 5.1 mmol/L and < 7.0 mmol/L postprandial GDM2/less‐tight glycaemic targets: FBG < 5.3 mmol/L and < 7.8 mmol/L postprandial All participants were instructed on diet and lifestyle changes. In case of exceeding the target blood glucose levels (in 2 or more measurements per week in group 1 and in more than 1/3 of measurements per week in group 2), insulin therapy was started. |
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| Outcomes | Infant outcomes: large‐for‐gestational‐age infants, perinatal death, composite of neonatal death or severe morbidity (nerve palsy, bone fracture, and shoulder dystocia), gestational age at birth, birthweight, macrosomia (birthweight > 4000 g), small‐for gestational‐age, and hypoglycaemia Maternal outcomes: pre‐eclampsia, mode of birth, mean daily fasting and postprandial capillary glucose concentration during treatment, proportion of glucose values within target, proportion of women requiring insulin therapy Subanalyses outcomes: gestational weight gain (kg), blood glucose average (mmol/L), fasting BG (mmol/L), 1‐hour postprandial blood glucose (mmol/L), number of blood glucose measurements, percentage treated with insulin, gestational age at delivery (weeks), caesarean section, birthweight (g), height (cm), large‐for‐gestational‐age, small‐for‐gestational‐age, Apgar score 1 min, Apgar score 5 min, glucose (mmol/L), C‐peptide (ng/mL), leptin (ng/mL), adiponectin (ng/mL), leptin/adiponectin ratio, ANGPTL4 in cord serum (ng/mL), ANGPTL4 relative expression in HUVECS |
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| Notes | Abstract only. Subanalyses performed. Funding: partly funded by the Russian Science Foundation (project no. 1514‐30012) Dates of trial: start July 2015 Declaration of interest: none to disclose |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Participants were 'randomly assigned' but unclear as to how (materials and methods) |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not described |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No apparent incomplete data at preliminary results stage |
| Selective reporting (reporting bias) | Low risk | Outcomes pre‐specified in protocol match study outcomes |
| Other bias | Unclear risk | Primarily in abstract form so information is described about the study methods and processes |