ANNEXURE II

1.    Name of the Candidate and           Dr. NILOFER A.R.
      Address                             D/O Dr. RAJASAB. A.H.
      (in block letters)                  PLOT NO -98,
                                          GULBARGA – 585105
2.    Name of the Institution             J.J.M. MEDICAL COLLEGE,
3.    Course of Study and Subject         MEDICAL
                                          M.S. IN OBSTETRICS AND
4.    Date of admission to Course         23- April 2008.
5.    Title of the Topic                  “SCREENING IN HIGH RISK GROUP OF
                                           GESTATIONAL DIABETES MELLITUS
                                             WITH ITS MATERAL AND FETAL

6.    Brief resume of the intended work

      6.1 Need for the study:
           Gestational Diabetes Mellitus (GDM) complicates 3.4% of all pregnancies
      globally and 90% of these cases are definitely associated with a significantly
      increased maternal and perinatal morbidity. However with early diagnosis and
      treatment, perinatal morbidity and mortality due to this disease can be decreased.

           Traditionally obstetricians have used Glucose Tolerance test (GTT) for the
      pregnant women who manifest certain risk factors like family history of diabetes,
      previous birth of large babies, previous adverse obstetric outcome etc. since GTT
      is a very time consuming method and Glucose challenge test (GCT) can be used as
      other alternative in patients with high risk factors. Hence the present study is
      undertaken to find out efficacy of GCT in detection of gestational diabetes in high
      risk group.
6.2 Review of Literature :
    A study of screening for gestational diabetes mellitus was carried out in 480
      high risk women attending Suvidha Mother and child Nursing home. The
      patients underwent GCT with 50gm Glucose (GCT) using Glucometer,
      between 18-20 wks and if negative, the test was again done after 28 wks. All
      120 patients with abnormal GCT were subjected to 3 hours 100 gm Oral
      Glucose tolerance test and 49 were found to have abnormal GTT. 3.05% of
      women were found to have Gestational Diabetes. Sensitivity of Glucose
      challenge test in detection of Gestational diabetes in high risk group is
      40.5%. GCT is hence reliable method to detect gestational diabetes mellitus
      in high risk group.1

    Universal screening for GDM was performed on 300 pregnant women with
      50gm 1 hour Oral Glucose challenge test (OGCT). Those with abnormal
      results were subjected to 100gm 3 hour oral glucose challenge test (OGTT).
      All women were followed till delivery and maternal and fetal outcomes were
      noted. A higher incidence of LSCS and preterm delivery was found amongst
      the positively screened and GDM cases. Adverse fetal outcome was found in
      gestational diabetes. The increased morbidity in GDM is preventable by
      meticulous antenatal care.2

    This study was conducted to investigate the effects of pregestational, as
      opposed to gestational diabetes on infant malformations. All women
      delivering infants at Parkland Hospital between Jan 1 1991 and Dec 31 2000
      were ascertained. Screening for gestational diabetes was methodically
      employed throughout the study period using National Diabetes Data Group
      Criteria for diagnosis of pregestational and gestational diabetes. It was
      concluded that women with pregestational diabetes or gestational diabetes
      plus fasting hyperglycemia have a three to four fold increased risk of infant
      malformations. Whereas women with mild gestational diabetes have
      malformation rates no different than     the general non diabetic obstetric
    This study was carried out in 800 consecutive women registering in
      antenatal clinic prior to 28 wks of gestation using 50 gm Glucose challenge
      test (GCT). The women were divided into two groups. Group 1 – with
      historical and clinical risk factors and group 2 – those without such risk
      factors. All patients with positive GCT were subjected to 3 hrs 100 gm oral
      glucose tolerance test (OGTT). Due to simplicity, acceptability, sensitivity
      and cost effectiveness of the procedure, GCT is recommended as a universal
      screening produce for all pregnant patients at 24-28 weeks of pregnancy.4

    Study was carried out on 3131 pregnant women who underwent both the
      screening and the diagnostic tests.. Study categorized each women’s risk of
      gestational diabetes mellitus on the basis of her age, body – mass index
      before pregnancy and race. Strategies were entailed as no screening for low-
      risk women, usual care for intermediate risk women, and universal
      screening with lower threshold plasma glucose values of 130mg per
      decilitre or 128 mg per decilitre for high risk women. It was hypothesized
      that, that the efficacy of screening would be enhanced by considering
      women’s risks of gestational diabetes on the basis of their clinical

6.3 Objectives of the study:

   1. To screen the high risk group for GDM using 50 gm, one hour Oral Glucose
       challenge test.

   2. To find the prevalence of GDM in the high risk group attending three
       hospitals attached to JJMC

   3. To study the maternal and fetal outcome in high risk group of GDM.
7.   Materials and methods:
     7.1 Source of data:
               Cases of High Risk pregnancy group of Gestational Diabetes attending the
     hospitals attached to JJM Medical college.
            Bapuji Hospital, DVG
            Chigeteri Hospital, DVG
            Women and children hospital, DVG

     7.2 Method of collection of data (including sampling procedure if any).

     Inclusion criteria :
           -   150 pregnant women with two or more High risk factors
           a) Age > 30 yrs
           b) Family h/o type 2DM
           c) Obesity (BMI > 27.5 kg/m2)
           d) h/o GDM in previous pregnancy
           e) h/o Macrosomia in previous pregnancy
           f) h/o fetal loss after 20 wks of gestation in previous pregnancy.
           g) h/o prematurity, congenital anomalies or unexplained fetal loss in precious
       -       Singleton or Multiple pregnancies
       -       Gestational age between 24 – 28 wks of gestation.

     Exclusion criteria :
               1) History of pregestational diabetes (overt diabetes)
               2) History of cardiac / respiratory / hepatic and other medical disease
               3) History of intake of drugs that effect glucose metabolism like
                   corticosteroids or progesterones
               4) Patients who refused to undergo screening and diagnostic test for GDM.
      High risk group pregnant women were screened for GDM by 50 gm one
hour Oral Glucose challenge test (OGCT). If OGCT was positive, the respective
patient will be subjected to 3 hr, 100gm oral Glucose, tolerance test. If OGTT was
positive, patient is labelled to have GDM.

Method of performing OGCT :
    Fasting is not a prerequisite
    50 gm glucose was dissolved in 200 ml of water and the patient was asked
      to drink it within 5 min.
    Time noted
    Precisely one hour after oral glucose administration a capillary blood
      specimen obtained and tested for sugar level by Glucometre
    If the blood value was > 140 mg/dl, then screening was considered as

Method of performing OGTT
    Initial blood sample was taken after 10-16 hrs of fasting.
    Within 5 min, patient was asked to drink 100 gm of Glucose dissolved in
      200-400 ml of water.
    2 ml blood samples were taken at an interval of 60 min, 120 min and at 180
    Blood sugar levels are read (as fasting, 1 hr, 2 hr, 3 hr values).
    Values obtained were compared with the values given by National Diabetes
      Data group.
      Fasting – 105 mg/dl
      1 hr – 190 mg/dl
      2 hr – 165 mg/dl
      3 hr – 145 mg/dl
    Patients were diagnosed as positive for GDM if at least two out of four
      values were met or exceeded.
    The prevalence of GDM in high risk group population is evaluated
    All the high risk group population in the study will be followed up till
      delivery to know Maternal and fetal outcome.
    The incidence of Neonatal morbidity is evaluated in high risk group like
      Macrosmia, Respiratory distress, Hyper bilirubinaemia, Hypoglycemia,
      Congenital malformations, still birth.

7.3 Does the study require any investigations or interventions to be conducted
on patients or other humans or animals? If so, please describe briefly:
        Blood : Hb%, Blood grouping and Rh typing
        HIV, HBSAG
        Glucose challenge test
        Oral Glucose tolerence test.
       The study involves only humans.

7.4 Has ethical clearance been obtained from your institution in case of 7.3?

     1. Gupta A, Gupta YV, Kumar S, Kotwal R. Screening of Gestational Diabetes
        Mellitus with Glucose Challenge Test in High Risk Group. “JK SCIENCE” J
        Med Edu Rese. April – 2006;8(2):89-91.

     2. Das V, Kamra S, Mishra A, Agarwal A, Agarwal CG. Screening for
        Gestational Diabetes and Maternal and fetal outcome. J Obstet Gynaec India
        Sep 2004;54(5):449-451.

     3. Sheffield JS, Butler-Koster EL, Carey BM, McIntire DD, Leveno KJ. Maternal
        Diabetes Mellitus and Infant malformations. Obstet Gynaec 2002;100:925-930.

     4. Bhattacharya C, Awasthi RT, Kumar S, Lumba PS. Routine screening for
        Gestational Diabetes Mellitus with Glucose challenge test in Antenatal
        patients. J Obstet Gynecol India. May/June 2001;51(3):75-78.

     5. Naylor CD, Servner M, Chen E, Farine D. Selective Screening for Gestational
        Diabetes Mellitus. The New England J Med Nov 1997;337:1591-1596.
9.   Signature of the Candidate

10. Remarks of the Guide           Efficient selective screening for GDM helps in
                                   preventing maternal and foetal morbidity. Thereby
                                   it improves the pregnancy outcome.
11. Name & Designation of
    (in block letters)
     11.1 Guide                    Dr. V.S. RAJU. M.D.
                                   DEPARTMENT OF OBSTETRICS AND
                                   J.J.M. MEDICAL COLLEGE,
                                   DAVANGERE - 577004.

     11.2 Signature

     11.3 Co-Guide (if any)

     11.4 Signature

     11.5 Head of the Department   Dr. DAKSHAYINI B.R., M.D. D.G.O
                                   PROFESSOR AND HEAD OF THE
                                   DEPARTMENT OF OBSTETRICS AND
                                   J.J.M. MEDICAL COLLEGE,
                                   DAVANGERE - 577004.

     11.6 Signature

12. 12.1 Remarks of the
    Chairman & The Principal

     12. 2 Signature

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