The primary objective is to compare the glucose curve with the OGTT, as a screening test for GDM.The secondary objective is to see if GDM treated after screening either with the glucose curve or with the OGTT, can predict perinatal complications and…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to compare the glucose curve with the OGTT, as a
screening test for GDM, 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 outcome
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 insulin or diet only. 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. Due to increasing insulin resistance with gestation of
pregnancy and multiple testing later on in pregnancy we hypothesize that we
identify more GDM.
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.
Background summary
Gestational diabetes mellitus (GDM) is defined as any type of hyperglycaemia
during pregnancy. It is known that GDM can cause more risks for perinatal
complications. GDM is often asymptomatic and therefore the diagnosis is found
by screening. Screening of GDM takes place when there are certain risk factors
and is essential to reduce perinatal complications with treating GDM that is
found by screening.
At the moment, screening strategies for GDM are under discussion. In many
clinics, the oral glucose tolerance test (OGTT) is used for screening GDM. The
OGTT is burdensome for most pregnant patients, as it is a time-consuming
function test and can cause nausea and vomiting. A possible alternative for the
OGTT is the glucose curve, but there is no evidence about the standardisation
and the applicability in the diagnostic work-up of GDM. The WHO considers
screening strategies for GDM a priority area for research.
The main study endpoint is to objectivy whether the glucose curve is a good
alternative for the OGTT screening for GDM. Futhermore we are interested in the
sensitivity in the glucose curve and the OGTT and their differences. Thereby,
we study whether the glucose curve is a good alternative for the OGTT
predicting perinatal complications. In addition, the patients experience
regarding the glucose curve and the OGTT will be investigated.
Study objective
The primary objective is to compare the glucose curve with the OGTT, as a
screening test for GDM.
The secondary objective is to see if GDM treated after screening either with
the glucose curve or with the OGTT, can predict perinatal complications and if
there is a difference between these two groups. The breakfast screeningstest
(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.
Study design
This is a prospective observational single-blinded non-inferiority study.
Patients who need screening for GDM will be asked to do an additional test for
GDM screening. The glucose curve and the OGTT will be performed in the same
week, and the results of the capillary blood glucose will be compared.
Study burden and risks
The possible side effects of the OGTT are nausea and vomiting due to the high
doses of sugar. There will be more capillary blood tests during this study
compared to the routine screening.
Laan op Zuid 668
Rotterdam 3071AB
NL
Laan op Zuid 668
Rotterdam 3071AB
NL
Listed location countries
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76738.078.21 |