Clinical Trial: Diagnosis of Gestational Diabetes in Eldoret, Kenya

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Establishing the Prevalance and Accuracy of Different Diagnostic Techniques for Gestational Diabetes in the Resource-constrained Setting of Eldoret, Kenya

Brief Summary: The objective of this study is to determine the most appropriate and effective approach for the diagnosis of gestational diabetes mellitus (GDM) among pregnant women receiving focused antenatal care at Moi Teaching and Referral Hospital (MTRH). This will be done through performing a random blood sugar, fasting blood sugar, 1 hr/2hr glucose tolerance test, and HbA1c on all participants who meet eligibility criteria and provide written, informed consent. The specific research question is: what is the most appropriate screening and diagnostic strategy for patients receiving antenatal care at MTRH?

Detailed Summary:

1.0 Background

Worldwide, 70 million women in the reproductive age have diabetes or impaired glucose tolerance placing them at risk of complications of hyperglycemia in pregnancy. The global prevalence rates of gestational diabetes mellitus (GDM) vary from between 12% and 14% depending on the population studied.(1,2) The estimated prevalence of GDM has been reported in Western (11.6%) and South Africa (3.8% - 8.8%) but because of the lack of published results and consistency in diagnosis, treatment, and outcomes in Eastern Africa, the extent of the problem of GDM is unknown in Kenya.(2) Estimates from these studies in sub-Saharan Africa (SSA) reveal a widely variable prevalence ranging from 2.4% to 14% with different methodologies and populations of different risk categories. This lack of focused investigation on GDM in Kenya is of concern as preliminary,unpublished data from the Kenyan Global Network Study on birth outcomes suggests that 5.5 % of birth weights in Western Kenya are greater than 4000g, suggesting a substantial potential burden of diabetes mellitus (DM) or GDM in this population.(3) Maternal hyperglycemia during pregancy predisposes the offspring to glucose intolerance in the future by fetal programming. (1,4,5) This vicious cycle can influence and perpetuate the incidence and prevalence of diabetes in any population. Infants born to mothers with diabetes experience double the risk of serious injury at birth, triple the likelihood of caeserean delivery and quadruple the incidence of newborn intensive care unit admissions.(6-8) These maternal, fetal, and neonatal morbidities attributable to diabetes in pregnancy can be prevented with early diagnosis of DM and effective treatment. Within the landscape of care in Western Kenya, pregnancy may be the only time a woman presents for medical care. Therefore, pregnancy is an opportune time to have a receptive audien
Sponsor: Indiana University

Current Primary Outcome: 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.


Original Primary Outcome: 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


Current Secondary Outcome: 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.



Original Secondary Outcome:

  • 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 ]
    We compared the gold standard venous test against a mix of point of care glucose and HbA1c tests.
  • Association of gestational diabetes with potential risk factors [ Time Frame: Measured between 24-32 weeks of pregnancy ]
    We assessed risk factors for the development of gestational diabetes


Information By: Indiana University

Dates:
Date Received: November 29, 2016
Date Started: July 2012
Date Completion:
Last Updated: December 2, 2016
Last Verified: December 2016