Stratification of Risk of Diabetes in Early Pregnancy
Stratification of Risk of Diabetes in Early Pregnancy
Hyperglycaemia in Pregnancy or Gestational Diabetes Mellitus (GDM) is one of the most common
 obstetric medical conditions which when undetected can cause significant adverse outcomes for
 the mother and the offspring. Diagnosis is typically made between 24-28 weeks of pregnancy
 using oral glucose tolerance test (OGTT). Therefore, some damage might have already happened
 prior to detection. Although universal screening is recommended by many guidelines, this is
 not uniformly followed across the world, partly because of doubts about cost-effectiveness.
 Only selective screening is followed based on presence of at least one of the high risk
 factors (age, BMI, previous history, etc). This strategy can miss up to 50% of GDM. In
 addition, no data exists in India and Kenya. In low and middle-income countries (LMICs),
 where majority live in rural settings, the major limitations are difficulty in conducting
 OGTT, which requires prompt access to laboratory facilities. Combining the clinical and
 easily analysable biochemical markers (composite risk score) could improve the prediction and
 if proven, could help to prevent the onset of GDM. Fasting glucose levels (at non-diabetes
 levels) in early pregnancy could predict future GDM. HbA1c in early pregnancy can be a better
 marker as it can be done point-of-care and does not require patients to be in a fasting
 state. The overall objective of the proposed project is to develop a composite risk score to
 predict GDM in early pregnancy using a combination of easily identifiable risk factors such
 as age, BMI, family history of Type 2 Diabetes along with HbA1c in Indians and Kenyans. The
 project will recruit pregnant women in early pregnancy from South India (n=3400) and Western
 Kenya (n=4000). Contribution of individual risk factors as well as the composite risk score
 on the risk of developing GDM will be assessed. Detailed health economic analyses will enable
 policy makers to make informed decision based on local data.
High glucose level in Pregnancy or Gestational Diabetes Mellitus (GDM) is one of the most
 common medical conditions during pregnancy. When undetected, it can cause significant harm
 for the pregnant women and her offspring. GDM can affect 5-25% of all pregnant women. It
 depends on the population and where the boundary is drawn between normal and abnormal glucose
 levels.

 Certain ethnic minority groups are considered at high-risk for developing GDM, including
 Indians. It is estimated >15% of pregnancies are affected by GDM in India. The immediate
 risks of untreated GDM are high rates of pre-eclampsia, higher caesarean section rates and
 psychological effects such as anxiety and depression. Women who develop GDM have a 7-8 times
 higher life-time risk of type 2 diabetes (T2D). Similarly, the immediate risks to the
 children are being too big or too small, shoulder damage during labour, low glucose levels or
 jaundice at birth, difficulty in breathing and in rare cases stillbirth. In the long term,
 the risk of obesity and T2D is also higher.

 The diagnosis of GDM is usually made between 24-28 weeks of pregnancy using a glucose drink
 test called oral glucose tolerance test (OGTT). Although treatment can improve the outcomes,
 some of the damage may have already been done before the detection of GDM. Therefore,
 screening to detect high glucose level in pregnancy seems beneficial. However, there can be
 harms as well as benefits in screening programmes. Therefore a balance should be achieved
 between identifying women whose blood glucose level is high enough to cause harm and those
 with glucose level that would not cause harm. Currently, it is recommended that all pregnant
 women should be screened for GDM if they belong to a high-risk ethnic population. However,
 conducting OGTT in India is challenging, as this test requires pregnant women present
 themselves to a laboratory facility in a fasting state.

 In many countries, women are selected for OGTT based on the presence of at least one of the
 high risk factors such as higher body weight, older age and family history of T2D. However,
 this selection method can miss up to 50% of women who may develop GDM. The aim of the study
 is to develop a risk score in early pregnancy based on a combination of these risk factors
 that can be collected easily along with a simple finger prick average blood glucose test
 (called HbA1c). The efficiency of different levels of this combined risk score will be tested
 against the risk of developing GDM in the later part of pregnancy.

 Cost effectiveness analysis will also be conducted to identify at what risk level screening
 can be recommended in India. An accurate score that can safely exclude women at low risk of
 developing GDM will have significant benefits to the pregnant women. They can be safely
 reassured. Avoiding the need for OGTT will have significant time and cost benefits. In
 contrast, if the score identifies them as at high-risk, healthy eating and appropriate life
 style advice can reduce their risk of developing GDM in later pregnancy.
Inclusion Criteria:

 -  All pregnant women between the age of 18 and 50 years of age

 Exclusion Criteria:

 -  Women presenting beyond 16 weeks of gestation Known Type 1 or Type 2 diabetes

 -  Severe anaemia defined as haemoglobin (Hb) <8g/L and

 -  Sickle cell traits, sickle cell anaemia and other genetic Hb variants

 -  Women on Metformin therapy for anovulation and/or infertility