The Clinical Utility of Glycated Albumin as an Index of Glycaemic Control in Type 1 Diabetic Pregnancy and its ability to predict Neonatal Outcome

Not Applicable

Completed

• Conditions: Type 1 Diabetes; Pregnancy; Metabolic and Endocrine - Diabetes; Reproductive Health and Childbirth - Normal pregnancy

• Registration Number: ACTRN12614001295639
• Lead Sponsor: orthern Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

Type 1 diabetes mellitus
- 11-18 weeks of gestation
- Aged > 18 years

Exclusion Criteria

- Severe renal impairment - > stage 3 chronic kidney disease
- Severe hepatic derangement - AST > 3 times upper limit of normal and/or ALT > 3 times upper limit of normal

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The correlation of measures of glycaemic control (as assessed by glycated albumin, HbA1c, fructosamine and 1,5-anhydroglucitol values) obtained throughout pregnancy with maternal and neonatal outcomes, particularly the incidence of macrosomia. Maternal and neonatal outcomes will be assessed by reviewing medical records and routine clinical data following delivery.<br>Maternal outcomes to be assessed include:<br>- Method of delivery (e.g. induction of labour, caesarean section)<br>- Perineal lacerations<br>- Postpartum haemorrhage<br>- Complications in labour<br>Neonatal outcomes to be assessed include:<br>- Birth weight<br>- Gestational age at birth<br>- Incidence of neonatal death<br>- Shoulder dystocia<br>- Bone fracture<br>- Nerve palsy<br>- Admission to neonatal intensive care unit (NICU)<br>- Hypoglycaemia<br>- Jaundice and/or jaundice requiring phototherapy<br>- Respiratory distress<br>[Post-pregnancy/delivery date]