Methods | Randomised, parallel‐group, open‐label, 2‐armed, active controlled trial. Period of study: 1 October 1979 ‐ 1 October 1982. |
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Participants |
Number randomised: 100. Eligible were type 1 diabetes mellitus (IDDM) and type 2 diabetes mellitus (NIDDM) pregnant patients attending the from 5 hospitals in Stockholm during the period of study. Inclusion criteria:
Exclusion criteria:
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Interventions |
Intervention: Patients self‐monitored their blood glucose at home from the 32nd week until the 36th week of gestation. Weekly hospital visit from 32‐36 weeks and then hospitalised during the 37th week until delivery (n = 54). Control: Patients were hospitalised from 32nd week until delivery (n = 46). |
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Outcomes |
Outcomes used in this review: 1) Mean blood glucose. 2) HbA1c. 3) Antenatal hospital stay (% requiring admission, length of stay). 4) Caesarean section rates. 5) Preterm birth. 6) Neonatal hypoglycaemia. 7) Perinatal death. 8) Neonatal hospital stay. Outcomes not used in this review: Maternal complications
Neonatal outcomes
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Notes |
Setting: 5 hospitals in Stockholm. Country: Sweden. Funding: Expressens Perinatal forskningsfond, AIImanna Barnbordshusets Minnesfond, Svenska Diabetesstiftelsen, Nordisk Insulinfond, Swedish Medical Research Council (Project No. 3787), and Tielman's Fund for Pediatric Research. Comments:
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment ‐ Not mentioned. |
Allocation concealment (selection bias) | Unclear risk | Comment ‐ Not mentioned. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Comment ‐ No blinding of participants and personnel. However, this may not affect the results as all outcomes were objectively measured. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment ‐ No blinding of outcome assessment. Objective measurements used. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment ‐ 1 excluded for severe drug addiction, 8 spontaneous abortions and 1 mother died. |
Selective reporting (reporting bias) | Low risk | No obvious risk to selective reporting. |
Other bias | Low risk | No obvious risk to other bias. |