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

This trial does not accept healthy volunteers

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 population

Pregnant patients over 18 years of age

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Glucose monitoring

    Procedure/Surgery

    Glucose monitoring

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Continuous glucose monitoring1 intervention

Trial outcomes

Primary outcomes

1

Value of CGM (Continuous glucose monitoring) at 12 and 28 weeks of gestation in the prediction of GDM (Gestational diabetes mellitus )

GDM is defined by abnormal results of 75mg OGTT(Oral Glucose Tolerance Test) at 28 weeks' gestation

Time frame
Up to 28 weeks

Secondary outcomes

1

Number of patients with Gestational hypertension

blood pressure readings are higher than 140/90 mm Hg in a woman who had normal blood pressure prior to 20 weeks and has no proteinuria (excess protein in the urine)

Time frame
Up to 28 weeks
2

Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks

Number of patients with Delivery by caesarean section

Time frame
Up to 28 weeks
3

Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks

Number of patients with Stillbirth, neonatal death, perinatal death

Time frame
Up to 28 weeks
4

Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks

Number of patients with Large for gestational age neonate (\>90th and 95th percentile for gestation)

Time frame
Up to 28 weeks

Other outcomes

Sponsors and contacts

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