Diabetes, Gestational Clinical Trial
Official title:
Establishing the Prevalance and Accuracy of Different Diagnostic Techniques for Gestational Diabetes in the Resource-constrained Setting of Eldoret, Kenya
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?
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investigation on GDM in Kenya is of concern as preliminary,unpublished data from the Kenyan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 audience to screen for possible pregestational diabetes, promote health
education, and diagnose glucose intolerance as the woman transitions beyond the postnatal
period.
MTRH is the second largest referral hospital in Kenya and serves as a referral center for
the whole of Western Kenya. Although access to healthcare is limited in rural areas of
Kenya, the Antenatal Clinic at the hospital serves up to 12,000 new mothers annually.
Screening for GDM in the antenatal clinic at MTRH is currently limited to a routine
urinalysis for glucosuria. Sutherland and colleagues found that 11% of an unselected
obstetric population of 1418 women had random glucosuria. However, only 1% of those with
glucosuria had an abnormal glucose tolerance test.9 Glucosuria is common in pregnancy and
has not been shown to correlate with the diagnosis of GDM.
2.0 Rationale and Specific Aims
The use of a routine urinalysis as a screening strategy for GDM is not consistent with any
national or international guidelines.(10-13) There is currently no consensus on the best
method to screen for GDM in rural settings lacking infrastructure for venous testing. There
are a variety of testing strategies which have been predominantly tested in resource-rich
settings and are now used as the standard of care worldwide. Unfortunately, these testing
strategies have not been validated or implemented in resource-constrained settings like
those existing in Western Kenya.(2) In the United Kingdom, there is a general lack of
consensus; most centers employ the 75g glucose tolerance test (Sensitivity 29% and
Specificity 96% - these values are for the 75g 2hr postprandial random blood sugar and not
the glucose tolerance test), others adopt a two-stage protocol, starting with 50g screen, to
be followed, if abnormal, with 75-g glucose tolerance test. Also, according to the WHO
criteria and ADA guidelines for GDM diagnosis, a random blood sugar >11mmol/L (198 mg/dL) or
a fasting blood sugar >7.0mmol/L (126 mg/dL) meets the threshold for diagnosis of GDM.(12)
Because of this uncertainty, the International Association of Diabetes and Pregnancy Study
Groups (IADPSG) has recently helped provide greater clarity to this issue by issuing
suggested guidelines for diagnosing both gestational diabetes and overt diabetes in
pregnancy. They recommend the 75gm oral glucose tolerance test and the cutpoints derived
from the Hyperglycemia and Adverse Pregnancy Outcomes (HAPO) study for all patients
receiving GDM screening.
As suggested in the IADPSG guidelines and an emerging body of literature, there is growing
support for the utilization of the glycosylated hemoglobin (HbA1c) in diagnosing diabetes.
(16) Lipska and colleagues report that women and people of African-American ethnicity are
more likely to be identified with dysglycemia using HgbA1c than by fasting blood glucose. A
notable weakness of this study is that it was performed in adults age 70-79 and thus it is
unlcear whether HbAIC can be used as a diagnostic tool in pregnancy. None of the currently
available studies evaluating the use of A1c's for GDM have included African women.(17-20)
Several studies have also raised concerns about the accuracy of HbA1c in African populations
as the HbA1c results tend to be higher than those seen in other populations.(21-23) Because
of the various approaches that are currently being proposed by the IADPSG guidelines, there
is still considerable debate over the appropriate test to employ as they recommend
performing a fasting blood sugar, HbA1c, or random plasma glucose on all women during their
first prenatal visit. If a diagnosis of diabetes is not made during this assessment, it is
recommended that a 75g oral glucose tolerance test is performed during the 24th to 28th week
of the pregnancy to test for GDM. By combining the results of several studies they have also
analyzed the additive benefits of combining different strategies. Through this investigation
they have concluded that analyzing fasting blood sugars alone enabled them to identify 8.3%
of the evaluable population, while the 1 hour glucose measurement identified another 5.7%,
and 2 hour glucose measurement identified an additional 2.1%. One major limitation of this
investigation, however, was that the cohort did not include patients reflective of the rural
SSA population the investigators on this trial serve in Western Kenya. This theme is
illustrated throughout this background as there is a deficiency of published results
regarding GDM in SSA populations.(10) The IADPSG diagnosis approach also assumes that the
vast majority of expectant mothers will have frequent contacts with the healthcare system
including early prenatal visits and subsequent visits throughout the pregnancy. This trend
is not commonly seen in SSA as a large proportion of expectant mothers deliver at home or
have only minimal contact with the healthcare system.(2) Because of these dynamics, there is
a clear need to simplify the diagnostic approach for GDM while also assessing the relative
utility of each of the testing strategies (ie. random blood sugar, fasting blood sugar, 1
hr/2hr glucose tolerance test, and HbA1c).
Through this proposal, the investigators hope to take the first step towards addressing GDM
in this setting by assessing the relative effectiveness of point of care testing strategies,
in comparison to the gold standard approach of using the 75gm oral glucose tolerance test in
a representative understudied population.
;
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