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. 2023 Oct 10;2023(10):CD011624. doi: 10.1002/14651858.CD011624.pub3

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)
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.
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
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
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