Screening gestational diabetes: glucose curve versus oral glucose tolerance test

Screening gestational diabetes: glucose curve versus oral glucose tolerance test - Screening gestational diabetes

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51070

Enrollment

473

Registered

2021-03-15

Start date

2022-03-07

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High suger levels in pregnancy

Interventions

Oral Glucose Tolerance Test (OGTT) versus glucose day curve (GDC) by using 'breakfast screeningstest' (BST)

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant woman and one of the following risk factors, whereas screening for GDM is necessary: o GDM in history; o Body Mass Index (BMI) above 30 kg/m2 before pregnancy; o An earlier child with a birth weight above 4500 gram or the 95th percentage; o A first-degree family member with diabetes or GDM; o Ethnic background: African, Turkish, Hindu, Asian, Latin-American; o Inta-uterine death in history without a medical explanation; o Polycystic ovarian syndrome.

Exclusion criteria

Exclusion criteria: All pregnant patients are screened for diabetes with random glucose at the beginning of the pregnancy before 16 weeks. Patients will be excluded if: - Diagnosed with diabetes mellitus type 1 or type 2; - Earlier diagnosed GDM during this pregnancy; - Age under 18 years; - Received bariatric surgery in their medical history, as this is a contra-indication for the OGTT. Patients will be excluded if they are unable to give written consent or when there is no proper understanding of Dutch or English.

Design outcomes

Primary

Measure	Time frame
The primary objective is to compare the glucose curve with the OGTT, as a screening test for GDM at 24-26 weeks of gestation, which gives the following questions: - Is there any difference in pre-prandial and postprandial capillary blood glucose values between the glucose curve and OGTT, and how are these glucose values related with the diagnosis of GDM? (paragraph 6.3.2) - What are the sensitivity and specificity of glucose curve in relation to the OGTT?	—

Measure

Time frame

The primary objective is to compare the glucose curve with the OGTT, as a screening test for GDM at 24-26 weeks of gestation, which gives the following questions: - Is there any difference in pre-prandial and postprandial capillary blood glucose values between the glucose curve and OGTT, and how are these glucose values related with the diagnosis of GDM? (paragraph 6.3.2) - What are the sensitivity and specificity of glucose curve in relation to the OGTT?

—

Secondary

Measure	Time frame
The secondary objective is to investigate if the predictive value of the glucose curve on perinatal outcomes after treating GDM is comparable with the predictive value of the OGTT. The hypothesis is that the glucose curve is not inferior to the OGTT in diagnosing GDM. All patients diagnosed with GDM will receive treatment, either only diet or if the women is not reaching normoglucous values diet and medical treatment. To verify this hypothesis, we investigate the perinatal outcomes. If the glucose curve is not inferior to the OGTT, it can be expected that the perinatal complications will be equally divided in both groups.  Another objective is to investigate how patients will experience the OGTT and the glucose curve, and if they have a preference. The breakfast screenings test (BST) consist of the first two glucoses of the glucose curve, another objective is to compare the BST and the OGTT just as mentioned above with the glucose curve.	—

Measure

Time frame

The secondary objective is to investigate if the predictive value of the glucose curve on perinatal outcomes after treating GDM is comparable with the predictive value of the OGTT. The hypothesis is that the glucose curve is not inferior to the OGTT in diagnosing GDM. All patients diagnosed with GDM will receive treatment, either only diet or if the women is not reaching normoglucous values diet and medical treatment. To verify this hypothesis, we investigate the perinatal outcomes. If the glucose curve is not inferior to the OGTT, it can be expected that the perinatal complications will be equally divided in both groups.  Another objective is to investigate how patients will experience the OGTT and the glucose curve, and if they have a preference. The breakfast screenings test (BST) consist of the first two glucoses of the glucose curve, another objective is to compare the BST and the OGTT just as mentioned above with the glucose curve.

—

Countries

Netherlands

Contacts

Public ContactG.M. Nieuwenhuyzen

Albert Schweitzer Ziekenhuis

g.m.boer@asz.nl0786523323

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)