Glucose Targets in gestational diabetes Pilot

Phase 2

Withdrawn

• Conditions: Gestational Diabetes Mellitus; Reproductive Health and Childbirth - Antenatal care; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12614001250628
• Lead Sponsor: Women's and Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-01
• Last Update Posted: 21 June 2021

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Pregnant women with gestational diabetes diagnosed on 75g OGTT: fasting glucose >=5.5 mmol/L and 2h glucose >=8.5 mmol/L, between 12 and 30 weeks gestation, with a singleton or twin pregnancy, not previously diagnosed as diabetic, attending antenatal care at collaborating hospitals, and giving informed written consent

Exclusion Criteria

>30+0 weeks gestation, or with triplets or higher order gravidity, or with major active medical disorders (including psychiatric disease requiring antipsychotic medication and inflammatory disorders requiring corticosteroid therapy, but not including chronic hypertension)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
maternal hypoglycaemia: self monitoring capillary blood glucose <3.0 mmol/L - number of episodes, symptomatic or not.<br>[following initiation of diet and lifestyle changes and hypoglycaemic therapy as required until delivery];severe maternal hypoglycaemia: self monitoring capillary blood glucose <2.5 mmol/L - number of episodes.[following initiation of diet and lifestyle changes and hypoglycaemic therapy as required until delivery]

Secondary Outcome Measures

Name	Time	Method
Birthweight[At delivery];neonatal hypoglycaemia in whole blood from heel prick <2.6 mmol/L<br>[4 hours of age];severe neonatal hypoglycaemia in whole blood from heel prick <2.0 mmol/L[at 4 hours of age]