Status:
TERMINATED
The Use of Early Pregnancy HbA1c in Predicting Excessive Fetal Growth in Women at Risk of Glucose Intolerance
Lead Sponsor:
Belfast Health and Social Care Trust
Collaborating Sponsors:
Queen's University, Belfast
Conditions:
Gestational Diabetes
Eligibility:
FEMALE
18+ years
Brief Summary
The association of hyperglycaemia in pregnancy (gestational diabetes mellitus; GDM) with adverse maternal and fetal outcomes is clearly recognised. Traditionally the diagnosis is made at 28 weeks gest...
Detailed Description
Study Aim: The overall aim of this study is to identify a feasible, easily adopted, early screening method for excessive fetal weight gain; a known risk factor for childhood obesity and type 2 diabete...
Eligibility Criteria
Inclusion
- \-
- Age ≥ 18yrs, and at least one of the following NICE risk factors for glucose intolerance:
- body mass index ≥ 30kg/m2 a family history of diabetes (first-degree relative) previous macrosomic baby (\>4.5kg) minority ethnic family origin with a high prevalence of diabetes
Exclusion
- \- pre-existing type 1 or type 2 diabetes mellitus, a previous history of GDM, booking HbA1c ≥ 48mmol/mol (6.5%), anaemia diagnosed on booking full blood count, booking diagnosis of a multiple pregnancy, use of corticosteroids or metformin within 12 weeks of booking
Key Trial Info
Start Date :
November 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 4 2020
Estimated Enrollment :
1314 Patients enrolled
Trial Details
Trial ID
NCT04858386
Start Date
November 1 2017
End Date
August 4 2020
Last Update
April 26 2021
Active Locations (1)
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1
Royal Jubilee Maternity Service
Belfast, Northern Ireland, United Kingdom, BT12 6BA