The Treatment Of BOoking Gestational diabetes Mellitus (TOBOGM) Pilot Study: Evaluating the impact on obstetric outcomes of immediate versus delayed care for gestational diabetes diagnosed at booking

Not Applicable

Completed

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

• Registration Number: ACTRN12615000974505
• Lead Sponsor: niversity of Western Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Pregnant women (aged >=18years) with a singleton pregnancy between 4 and 19+6 weeks’ gestation, attending the hospital Book in clinic, with a risk factor for GDM warranting an OGTT according to ADIPS/local guidelines. Ability to read and understand English for consent purposes.

Exclusion Criteria

Existing diabetes, inability to give consent, twins or triplets (or more), major active medical disorders (eg psychiatric disease requiring antipsychotic medication), women without a GDM risk factor, women >=20 weeks gestation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of study as assessed by the number of eligible participants recruited and lost to follow-up<br><br>[Birth];Maternal: Composite of pre-eclampsia/PIH <br><br>This will be collected from the notes<br>[Birth];Neonatal: 1-Pregnancy-Composite of 1 hour heelprick glucose =<2.2 mmol/l, respiratory distress, phototherapy, birth trauma, 5 min APGAR score <7, pre-term birth (<37 weeks), miscarriage/stillbirth/death, shoulder dystocia <br><br>These will be collected from the notes[Birth]