Comparison of Point-Of-Care Testing and venous blood glucose samples at the oral glucose tolerance test in pregnancy: a prospective observational cohort study

Completed

Conditions: Gestational diabetes mellitus
10018424
10010273

Registration Number: NL-OMON51068

Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary: Trial is onging in other countries

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 353

Inclusion Criteria

Pregnant patients
12-40 weeks of gestation
Indication for OGTT:
- Based on the outcome of the EXPECT calculator. The calculator is a tool we
use in our regional midwifery collaboration to draft a risk profile for
pregnant women. The calculator is used to counsel patients and develop a
personal plan for obstetric care. This calculator uses a cut-off value of *
3.5% on the risk of GDM.
- Based on risk factors:
- GDM in previous pregnancy
- BMI > 30 (kg/m2) at the first prenatal check-up
- An earlier child with a birthweight > P95 or > 4500 grams
- First-degree family member with diabetes
- Certain ethnic groups in which diabetes is common (South Asians,
including Hindus, Afro-
Caribbean, Middle Eastern women, Morocco and Egypt)
- Unexplained intrauterine fetal death in de past
- Polycystic ovary syndrome (PCOS)
- Based on symptoms in the pregnancy, such as macrosomia and/or polyhydramnios

Exclusion Criteria

- Unable to read informed consent in Dutch or English
- Pre-gestational diabetes mellitus (type I or II)
- Using glucose lowering medication (for example Metformin or Glyburide)
- History of bariatric surgery with dumping in the past

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The difference in clinical decision between capillary glucose samples and<br /><br>venous glucose samples in diagnosing patients with gestational diabetes<br /><br>mellitus. The utility and diagnostic accuracy of capillary glucose samples<br /><br>(POCT; Roche Accu-Chek Inform II) will be compared to venous glucose samples<br /><br>with laboratory determinations as the gold standard. To determine the<br /><br>diagnostic accuracy the sensitivity, specificity, positive predictive value and<br /><br>negative predictive value of POCT will be compared to the laboratory<br /><br>determination.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* The difference between capillary and venous glucose values will be compared,<br /><br>for both fasting and one- and two-hour glucose values.<br /><br>* Investigate whether adjusted cut-offs can be found for the diagnosis of GDM<br /><br>based on POCT without compromising the diagnostic accuracy. Sensitivity,<br /><br>specificity, positive predictive value, negative predictive value and area<br /><br>under the curve will be measured for different cut-off values.</p><br>