To compare the burden for pregnant women and diagnostic capabilities of the oral glucose tolerance test (75g and 50g) and blood glucose samples during the day.
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
Blood glucose samples in venous plasma.
The burden of the diagnostic tests, measured by a questionnaire for pregnant
women.
Secondary outcome
None.
Background summary
According to the Dutch societies of Obstetrics and Gynaecology and Internal
Medicine, the oral glucose tolerance test (75 g) is the most accurate
diagnostic test for gestational diabetes. Pregnant women who are at risk to
acquire gestational diabetes must recieve this test at 24-28 weeks of
gestation. Because of its practical limitations including time and unpleasant
side effects from drinking the glucose solution gynaecologists are reluctant to
use this test. We compare the side effects and diagnostic capabilities of the
two oral glucose tolerance tests (75g and 50g) and blood glucose samples during
the day.
Study objective
To compare the burden for pregnant women and diagnostic capabilities of the
oral glucose tolerance test (75g and 50g) and blood glucose samples during the
day.
Study design
Observational study with invasive measurements partly randomized.
Study burden and risks
The oral glucose tolerance test (50g) and blood glucose samples during one day.
postbus 888
8901 BR Leeuwarden
NL
postbus 888
8901 BR Leeuwarden
NL
Listed location countries
Age
Inclusion criteria
large for gestational age (> p95), Polyhydramnion (AFI> 24 cm), Diabetes mellitus in the family, history of gestational diabetes, macrosomia (>p97,5) and/of unexplained intra-uterine death. body mass index> 27 kg/m2, mediterrane or hindoestane ethnicity.
Exclusion criteria
History of diabetes mellitus,
random glucose > 7.8mmol/l before 20 weeks of pregnancy.
Design
Recruitment
Medical products/devices used
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 | NL26812.099.09 |