Bevier 1999.
Methods | Randomised controlled trial. | |
Participants | 103 women with a positive 50 g 1‐hour GCT (> 140 mg/dl) but a negative 100 g 3‐hour OGTT according to the National Diabetes Data Group (NDDG) criteria (see notes). Exclusion criteria: women with evidence of hypertension, collagen disease, chronic renal disease, cardiac or pulmonary disease, Rh sensitisation, or a history of preterm labor or SGA infants. Setting: Santa Barbara, California, USA. |
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Interventions |
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Outcomes | Maternal HbA1c level, pre‐eclampsia, mode of birth, delivery complications (shoulder dystocia, tight nuchal cord, meconium, prolonged labor phase, abnormal fetal heart rate), gestational age at birth, Apgar score at 1 min and 5 min, birthweight, infant haemoglobin, glucose, haematocrit, morbidities, and congenital anomalies. | |
Notes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as women were randomly assigned to either experimental or control groups. |
Allocation concealment (selection bias) | Unclear risk | No information was given on allocation concealment. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Prenatal care and deliveries were performed by six obstetricians who were not blinded to the mothers treatment group. Participants were unlikely to be blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information on whether outcome assessors were blinded or not. |
Incomplete outcome data (attrition bias) All outcomes | High risk |
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Selective reporting (reporting bias) | High risk | There was no clear definition on macrosomia. Published data on macrosomia was unclear, and cannot be included in the meta‐analysis of macrosomia. |
Other bias | Low risk | No obvious risk of other bias. |