Methods | Randomised, parallel‐group, open‐label, 2‐armed, active controlled trial. Period of study: not mentioned. |
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Participants |
Number randomised: 61 Eligible were type 1 diabetes mellitus (IDDM) pregnant patients attending or referred to the Regional Joint Metabolic/Antenatal Clinic at the Royal Maternity Hospital, Belfast during the period of study. Inclusion criteria:
Exclusion criteria:
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Interventions |
Intervention: Pre‐prandial glucose monitoring (n = 31). Control: Post‐prandial glucose monitoring (n = 30). |
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Outcomes |
Outcomes used in this review: 1) Maternal glycaemic control (HbA1c, fasting blood glucose, post‐prandial blood glucose, fructosamine). 2) Birthweight. 3) Caesarean section rates. 4) Gestational age (at birth). 5) Frequency of neonatal hypoglycaemia. 6) Neonatal intensive care admissions. 7) Stillbirth. Outcomes not used in this review: 1) Insulin dosage. 2) Pre‐eclampsia. 3) Success in glycaemic control. 4) Compliance with schedule. 5) Birth trauma. 6) Cord Insulin. 7) Cord IGF‐1. 8) Neonatal glucose at age 1 hour. 9) Triceps skinfold thickness. 10) Subscapula skinfold thickness. |
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Notes |
Setting: Regional Joint Metabolic/Antenatal Clinic at the Royal Maternity Hospital, Belfast. Country: UK. Funding: Department of Health and Social Sevices, Northern lreland, the Northern Ireland Mother and Baby Appeal, the Metabolic Unit Research Fund, Royal Victoria Hospital, Belfast, the Royal Maternity Hospital, Royal Victoria Hospital, Belfast, and the Irish Perinatal Society. Comments:
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote ‐ "Women were randomly assigned at 16 weeks' gestation to 1 of 2 blood glucose monitoring protocols". Comment ‐ method not mentioned. |
Allocation concealment (selection bias) | Low risk | Quote ‐ "allocations were via a sealed envelope system, which the patient selected from a box at the clinic visit". |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Comment ‐ No blinding of participants and personnel. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment ‐ No blinding of outcome assessment. However, all outcomes were objectively measured. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote ‐ "74 patients were recruited. 13 were excluded because they did not have results for analysis. This left 61 diabetic women (31 pre‐prandial and 30 post‐prandial monitoring) with results suitable for analysis". |
Selective reporting (reporting bias) | Low risk | No obvious risk to selective reporting. |
Other bias | Low risk | No obvious risk to other bias. |