Diagnosis of Gestational Diabetes in Eldoret, Kenya
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|ClinicalTrials.gov Identifier: NCT02978807|
Recruitment Status : Completed
First Posted : December 1, 2016
Last Update Posted : December 5, 2016
|Condition or disease||Intervention/treatment|
|Diabetes, Gestational||Procedure: Point of care and venous screening|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||935 participants|
|Official Title:||Establishing the Prevalance and Accuracy of Different Diagnostic Techniques for Gestational Diabetes in the Resource-constrained Setting of Eldoret, Kenya|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||April 2016|
Pregnant women between 24 to 32 weeks
Pregnant women with a singleton pregnancy who presented to care between 24 -32 weeks of their pregnancy were included in this study.
All patients enrolled in the study will receive a random point of care blood sugar, point of care and venous fasting blood sugar, point of care and venous 1 hr/2hr glucose tolerance test, and point of care and venous HbA1c.
Procedure: Point of care and venous screening
- Prevalence of Gestational Diabetes via venous 75 gm oral glucose tolerance test [ Time Frame: Measured between 24-32 weeks of pregnancy ]We determined prevalence of gestational diabetes by utilizing the gold standard testing strategy recommended by IADPSG. This includes the completion of a venous fasting blood sugar, provision of a 75 gm glucose, 1 hr post prandial venous glucose assessment, 2 hour post prandial venous glucose assessment. We recruited 935 patients of which 616 patients returned for the venous testing and completed these tests.
- Specificity, Sensitivity, positive predictive value, and negative predictive value of alternative point of care screening strategies [ Time Frame: Measured between 24-32 weeks of pregnancy ]
On day 1, a capillary blood sample was obtained to perform a point of care (POC) random blood glucose test and glycated hemoglobin. A 50gm glucose load was then administered capillary blood samples were collected after 1-hr All participants were then expected to return the next day (or within 1 week for those unable to follow-up immediately) after having fasted overnight for ≥ 8 hours.
Day 2 testing procedures included recommended IADPSG testing alongside the analogous POC tests. Capillary and venous blood samples for measurement of POC and plasma fasting glucose, venous HbA1c and a complete blood count with differential was performed. A 75gm glucose load was then administered with capillary and venous blood samples collected at 1-hr and 2-hrs for measurement of POC and plasma glucose levels.
The sensitivity, specificity, NPV and PPV of each screening strategy was determined using 2 by 2 matrices with the IADPSG criteria for the venous 75gm OGTT as the gold standard reference.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02978807
|Principal Investigator:||Sonak D Pastakia, PharmD, MPH||Purdue University, Moi University, Indiana University|