Status:
RECRUITING
First Trimester Prediction of Gestational Diabetes Mellitus by Continuous Glucose Monitoring.
Lead Sponsor:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Collaborating Sponsors:
King's College Hospital NHS Trust
Conditions:
Gestational Diabetes Mellitus in Pregnancy
Eligibility:
FEMALE
18+ years
Brief Summary
Gestational diabetes mellitus (GDM) is the most common complication of pregnancy, with an incidence rate of 10-15% \[1\]. Common risk factors for GDM are increased maternal age and weight and as a con...
Eligibility Criteria
Inclusion
- Maternal age ≥ 18 years
- Planned antenatal care at the same centre (i.e. not planning to move before delivery).
- Singleton pregnancy.
- Informed and written consent.
Exclusion
- Age \<18 years;
- Multiple pregnancy in current pregnancy;
- Unconscious or very ill; · Serious mental illness;
- Learning difficulties;
- Not fluent in local language and absence of interpreter;
- Severe congenital anomaly on ultrasound;
- Pre-existing diabetes mellitus type 1 or 2;
- Patients undergoing metformin therapy for infertility.
- Significant pre-pregnancy comorbidities that increase risk in pregnancy, for example renal failure, severe liver disease, transplantation, cardiac failure, psychiatric conditions requiring in-patient admission (\<1 year);
- Significant co-morbidity in the current pregnancy, nephropathy (estimated GFR \<60ml/min), other physical or psychological conditions likely to interfere with the conduct of the study and/or interpretation of the trial results;
- Participating in another intervention study that influences outcomes of this study;
- Allergy to adhesive materials;
- Allergy to any of the components of the glucose test:
Key Trial Info
Start Date :
March 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06874907
Start Date
March 1 2025
End Date
July 1 2026
Last Update
March 13 2025
Active Locations (1)
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1
HCUVA
El Palmar, Murcia, Spain, 30120