Actively Recruiting
First Trimester Prediction of Gestational Diabetes Mellitus by Continuous Glucose Monitoring.
Led by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Updated on 2025-03-13
1000
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
Sponsors
F
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Lead Sponsor
K
King's College Hospital NHS Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 consequence of women delaying childbirth and increasing incidence of obesity, there is a corresponding increase in the rate of GDM. GDM is associated with an increased risk of maternal and perinatal short and long-term complications . These include macrosomia, shoulder dystocia, neonatal hypoglycaemia, neonatal hyperbilirubinemia, and perinatal mortality. Maternal complications include higher risks of hypertensive disorders, perineal trauma, and caesarean section. Additionally, both the mothers with GDM and their infants have an increased risk of developing type 2 diabetes mellitus and cardiovascular disease later in life . Screening and diagnosis of GDM is currently based on an oral glucose tolerance (OGTT), which is carried out at 26-28 weeks' gestation. In addition, an OGTT is carried out at 11-13 weeks in women considered to be at increased risk of GDM based on their demographic characteristics and medical history. Screening and diagnosis of GDM is traditionally delayed until the late second or early third trimester of pregnancy with the rationale that the diabetogenic effects of pregnancy increase with gestation and therefore delayed testing would maximize the detection rate.
CONDITIONS
Official Title
First Trimester Prediction of Gestational Diabetes Mellitus by Continuous Glucose Monitoring.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Maternal age 218 years
- Planned antenatal care at the same centre (i.e. not planning to move before delivery)
- Singleton pregnancy
- Informed and written consent
You will not qualify if you...
- Age under 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 within the past year
- Significant co-morbidity in the current pregnancy, nephropathy (estimated GFR under 60ml/min), or other physical or psychological conditions likely to interfere with the study or its 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
HCUVA
El Palmar, Murcia, Spain, 30120
Actively Recruiting
Research Team
C
Catalina de Paco Matallana, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here