Comparison of iron status of normoglycaemic pregnant women with gestational diabetes mellitus: An observational study

Abstract

Objective: To evaluate/examine the influence of elevated serum ferritin and serum iron as a risk factor for Gestational Diabetes Mellitus Study Design: The study was designed as case control study Study Population: Study population includes pregnant females attending the OPD and IPD department of obstetrics and gynaecology in Maharaja Agrasen Hospital, New Delhi. Minimum of 60 women fulfilling the selection criteria were selected. Sample Size and Sample Technique: The primary objective of the study is to find the association between serum ferritin, iron and gestational diabetes mellitus. With reference to previous study 84, thus a sample size of 21 was calculated based on a difference of 100 in mean serum iron between control and study group, with a SD of 100, at two-sided alpha of 0.05, and a power of 90%. The formula for calculated sample size is given below n = (σ12 + σ22. [Z 1- α/2 + Z 1- β] 2 (M1 - M2)2 = (1002 + 1002) [1.96+1.282]2 / (100)2 = (20000) (10.51) / (10000) = 21 But we will be taking 30 patients per group. Where M1 = Mean of serum iron in control group. M2 = Mean of serum iron in study group. σ1 = SD of serum iron in control group. σ2 = SD of serum iron in study group. Z 1- α/2 and Z 1- β are probability of two errors So total 60 was taken sample size 30 as case and 30 as control. Statistical Methods Statistical testing will be conducted with the statistical package for the social science system version SPSS 17.0. Continuous variables will be presented as mean {plus minus} SD or median if the data is unevenly distributed. Categorical variables will be expressed as frequencies and percentages. The comparison of continuous variables between the groups will be performed using Students t test. Nominal categorical data between the groups will be compared using Chi-squared test or Fishers exact test as appropriate. Non-normal distribution continuous variables will be compared using Mann Whitney U test. For all statistical tests, a p value less than 0.05 will be taken to indicate a significant difference Main Outcome, Result and Conclusion: In our study level of serum ferritin was found elevated in case group with mean +SD of122.57 {plus minus} 17.92 and p value of