| Abstract |
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 1-25% 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 and Afro-Caribbeans. It is estimated >15% of pregnancies are affected by GDM in India but there are no published data from Kenya. The immediate risks of untreated GDM are high rates of pre-eclampsia (very high in Africa), 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 rarely death (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 an oral glucose tolerance test (OGTT). Although treatment can improve the outcomes, some of the damage may have already been done to the unborn baby 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. As a recent BMJ article said, "a label of gestational diabetes brings with it an intervention package that includes glucose monitoring, extra clinic visits, more obstetric monitoring with greater likelihood of labour induction, operative delivery and admission of the baby to special care, and finally for the mother a label of high risk for diabetes". We therefore need to try and achieve a balance 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 rural India and Kenya is challenging, as this test requires pregnant women present themselves to a laboratory facility in a fasting state. In many countries, including the UK, 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 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 and Kenya. An accurate score that can safely exclude women at low risk of developing GDM and will have significant benefits to the pregnant women. They can be 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. In addition to the direct benefit for the pregnant women and their offspring, the proposed study will also benefit policy makers, governmental and non-governmental organisations both in India and Kenya. The detailed clinical efficiency and health economic evaluations will enable these organisations to allocate the scarce resources to be focused on the high-risk women living in the low and middle-income countries like India and Kenya |
