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. 2019 May 23;2019(5):CD009613. doi: 10.1002/14651858.CD009613.pub4

Manderson 2003.

Methods Randomised, parallel‐group, open‐label, 2‐armed, active controlled trial.
Period of study: not mentioned.
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: type 1 DM pregnant women at 16 weeks' gestation.
Exclusion criteria: women without results due to reasons such as: stillbirth, abortions, major congenital abnormalities.
Interventions Intervention: pre‐prandial glucose monitoring (n = 31).
Control: post‐prandial glucose monitoring (n = 30).
Outcomes Outcomes used in this review

  1. Caesarean section.

  2. Large‐for‐gestational age.

  3. Perinatal mortality (stillbirth and neonatal mortality).

  4. Pre‐eclampsia.

  5. Weight gain during pregnancy.

  6. Insulin dose.

  7. Maternal glycaemic control (HbA1c, fasting blood glucose, post‐prandial blood glucose, fructosamine).  

  8. Stillbirth.

  9. Gestational age (at birth).

  10. Preterm birth < 37 weeks.

  11. Macrosomia.

  12. Birthweight (kg).

  13. Respiratory distress syndrome.

  14. Neonatal hypoglycaemia.

  15. Neonatal jaundice.

  16. Cord IGF.

  17. Neonatal glucose at age 1 hour.

  18. Transient tachypnoea.

  19. Neonatal intensive care admissions.
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.
Declarations of interest: not reported.
Comments

  1. No sample size estimation reported.

  2. No type 2 DM pregnant patients included.

  3. Only white women were included.

  4. Patients were reviewed fortnightly or more frequently if clinically indicated.

  5. Insulin doses were adjusted to achieve fasting glucose values between 60 mg/dL and 90 mg/dL (3.3 mmol/L and 5.0 mmol/L), pre‐prandial values between 60 mg/dL and 105 mg/dL (3.3 mmol/L and 5.9 mmol/L), and post‐prandial values less than 140 mg/dL (7.8 mmol/L).

  6. Post‐prandial glucose monitoring may significantly reduce the incidence of pre‐eclampsia and neonatal triceps skinfold thickness compared with pre‐prandial monitoring.
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.