First Trimester Prediction of Gestational Diabetes Mellitus by Continuous Glucose Monitoring.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorFundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

About this trial

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

Qualifiers

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.

Disqualifiers

Age <18 years;

Multiple pregnancy in current pregnancy;

Unconscious or very ill; · Serious mental illness;

Learning difficulties;

Trial design

Treatments tested in this trial

  • Glucose monitoring

Treatment groups

1,000 Participants
are divided into 1 treatment group

Locations

1
HCUVA30120, El PalmarMurcia, Spain

Sponsors and collaborators

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Lead sponsor

King's College Hospital NHS Trust

Collaborator