CTRI

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Any degree of glucose intolerance that begins or is first noticed during pregnancy is known as gestational diabetes (gestational diabetes mellitus): When examined between 24 and 28 weeks of pregnancy, women who satisfy the criteria for diagnosis are often given the diagnosis

GDM is a disorder that affects up to 5 million women annually in India, raising concerns about world health. According to recent studies, the prevalence of G.D. has risen over the past ten years, and rates may be higher in particular racial or ethnic communities. GDM puts the mother and fetus in danger

G.D.M. raises the possibility of obstetrical problems and unfavorable fetal outcomes. Preeclampsia, Caesarean section, stillbirth, macrosomia and hypoglycemia are a few of these. Additionally, a history of G.DM. is connected with a greater risk of G.D.M in future pregnancies and the development of type 2 diabetes and cardiovascular disease in later l

In 2010, the American Diabetes Association (A.D.A.) included an HbA1c test as a diagnostic criterion for diabetes (D.M.) in the general population.14 The cut-off of HbA1c â‰¥48 mmol/mol (6.5%) was established for the diagnosis and was endorsed by the World Health Organization (WHO) in 2011. In pregnancy, glycosylated hemoglobin of more than 6.5% is considered overt diabetes mellitus and 5.7-6.4 as G.D.M.

It has long been known that high levels of glycosylated hemoglobin during the periconceptional stage lead to poor neonatal outcomes. The rate of fetal malformations is positively correlated with higher maternal HbA1c levels, and the rate of significant abnormalities was shown to be three to five times higher in the group of women with poor metabolic control (early maternal HbA1c concentration >7%). Also, their research revealed that ultrasound exams were able to identify seven (41.2%) of the 58.8% of malformations that were cardiovascular and genitourinary in nature. When compared to the group with adequate control, the total pregnancy loss rate in the poor control group increased by approximately.

Recent results from the Hyperglycaemia and Adverse Pregnancy Outcomes (HAPO) Study showed that HbA1c measurements, similar to glycemia levels, were significantly associated with all adverse outcomes and higher levels of maternal HbA1c were related to a greater frequency of adverse outcomes It also showed that increasing glucose concentration less severe than diabetes is associated with fetal overgrowth, specifically adiposity.

There are studies conducted that showed that glycosylated hemoglobin measurement in the late trimester could be used as a screening test for fetal outcomes in normal patients.18 However, associations of the obstetric outcomes with glycosylated hemoglobin in the subgroup of the population at risk of developing G.D.M. whose glycemic values remained normal throughout pregnancy were studied less frequently. This Study will be conducted to evaluate the association between glycosylated hemoglobin and obstetric outcomes in patients at risk of GDM

For the 2013 who diagnostic criteria , diagnosis of GDM was made using 75gm OGTT when one or more of the following results are recorded

Fasting plasma glucose >5.1-6.9mmol/L

1 hour post 75gm oral glucose load >10mml/L

2 hour post 75 g oral glucose load >, 8.5-11.0mmol/L