NCT06874907 First Trimester Prediction of Gestational Diabetes Mellitus by Continuous Glucose Monitoring.
| NCT ID | NCT06874907 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia |
| Condition | Gestational Diabetes Mellitus in Pregnancy |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2025-03-01 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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:
Contact & Investigator
Catalina de Paco Matallana, MD
PRINCIPAL INVESTIGATOR
HCUVA
Frequently Asked Questions
Who can join the NCT06874907 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Gestational Diabetes Mellitus in Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06874907 currently recruiting?
Yes, NCT06874907 is actively recruiting participants. Contact the research team at katy.depaco@gmail.com for enrollment information.
Where is the NCT06874907 trial being conducted?
This trial is being conducted at El Palmar, Spain.
Who is sponsoring the NCT06874907 clinical trial?
NCT06874907 is sponsored by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia. The principal investigator is Catalina de Paco Matallana, MD at HCUVA. The trial plans to enroll 1,000 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.