SYNOPSIS
Rajiv Gandhi University of Health Sciences, Karnataka,
Bangalore.
OFFSPRING BIRTH WEIGHT AND MATERNAL FASTING LIPIDS IN WOMEN SCREENED FOR GESTATIONAL DIABETES MELLITUS
Name of the candidate : DR. JANAKI MENON C.M
Guide : DR. NAGARATHNA .G
Co Guide : DR.SUDEEP .K
Course and Subject : M.S (Obstetrics and Gynaecology)
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY
Father Muller Medical College,
Kankanady, Mangalore – 575002.
August – 2013
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE
ANNEXURE – II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1. / NAME OF THE CANDIDATE AND ADDRESS / Dr. JANAKI MENON C.Mpost Graduate Resident
Dept of OBSTETRICS and GYNaECOLOGY
Father muller medical college
Kankanady
Mangalore – 575002
2 / NAME OF THE INSTITUTION / Father muller medical college
Kankanady
Mangalore – 575002
3. / COURSE OF STUDY AND SUBJECT / MS (OBSTETRICS and GYNaECOLOGY)
4. / DATE OF ADMISSION TO COURSE / 27-05-2013
5. / TITLE OF THE TOPIC
OFFSPRING BIRTH WEIGHT AND MATERNAL FASTING LIPIDS IN WOMEN SCREENED FOR GESTATIONAL DIABETES MELLITUS
6. / BRIEF RESUME OF THE INTENDED WORK:
6.1 NEED FOR THE STUDY:
The most common neonatal complication of gestational DM is macrosomia. During early pregnancy an accumulation of maternal fat depots occurs followed by increased adipose tissue lipolysis and subsequent hyperlipidemia which mainly corresponds to increased triglycerides in all circulating lipoproteins. In GDM women the enhanced insulin resistance and altered oestrogen progesterone ratio are responsible for the reported wide range of dyslipidemic conditions.1 Association of high maternal glucose levels and fetus macrosomia have been documented. We have undertaken this study to understand the relationship of hyperlipidemia in GDM pregnancy and the relationship between triglyceride levels and fetal macrosomia.
6.2 REVIEW OF LITERATURE:
The prospective Amsterdam Born children and development cohort study, reported that high maternal TG levels in early pregnancy were associated with higher BWs and subsequently a higher occurrence of LGA births, whereas low TG levels were associated with accelerated postnatal growth. 5
GDM induces a state of dyslipidemia consistent with insulin resistance. During pregnancy women with GDM do have higher serum triacylglycerol concentrations but lower LDL cholesterol concentrations than do normal pregnant women. Total cholesterol,HDL and lipoprotein concentrations are not significantly different between GDM patients and control subjects. 6
Women with GDM had higher mean fasting triglycerides than those women who did not have GDM(p<0.001).Of women with GDM,91% had a triglyceride level > 30.6 mg/dl compared with 49% in women who did not have GDM(p< 0.05).
On univariate analysis, increased maternal triglycerides were associated with increased birth weight (p<0.03).When modeled triglyceride levels increased by 4.464mg/dl for each 1.0 kg increase in birth weight.2
In a german study of 150 women with GDM ,maternal triglycerides correlated positively with fetal abdominal circumference at 28 weeks, birth weight and neonatal fat mass. 3
In a Korean study of 104 women diagnosed with GDM,maternal hypertriglyceridemia at 24-32 weeks gestation was an independent parameter for identifying term for large for gestational age newborns. 4
In their study, Knopp et al reported a significant association between maternal triglyceride levels and neonatal weight both in normal and in GDM complicated pregnancy. 7
Kitijama et al reported maternal triglyceridemia as a significant predictor of LGA. 8
Both maternal triglycerides and non esterified fatty acids levels but not glucose in pregnancies with well controlled gestational diabetes mellitus have been shown to correlate positively with both neonatal weight and fat mass. 9
The catabolic condition of maternal adipose tissue during late gestation is associated with hyperlipidemia mainly corresponding to plasma rise in TG, with smaller rise in phospholipids and cholesterol. 10
Significantly elevated triglyceride levels in cord blood of obese GDM patients with macrosomic fetus suggests that TG may be important in the pathogenesis in fetal macrosomia. 11
6.3 OBJECTIVES OF THE STUDY:
1. To correlate the relationship between fasting cholesterol and Triglycerides and offspring birthweight in women screened for GDM
2. To correlate the relationship between fasting maternal cholesterol, Triglycerides and perinatal outcome.
7. / MATERIAL AND METHODS
SOURCE OF DATA :
Antenatal mothers with positive OGCT coming to the department of OBG, Father Muller Medical College and Hospital
STUDY TYPE: Prospective observational study
7.2 METHOD OF COLLECTION OF DATA:
Duration of study: Two years
Sample size: Minimum 50 patients selected using purposive sampling technique,
All Antenatal mothers are advised to undergo OGCT test as part of universal screening for GDM according to their convenience. Venous Plasma glucose levels after one hour of intake of 50g glucose is calculated. Minimum of 50 Patients with positive OGCT (> 140mg/dl) are selected. Detailed clinical evaluation including relevant history and physical examination will be undertaken. They are asked to undergo OGTT test. Fasting plasma venous blood glucose value, followed by 1, 2 and 3 hr plasma glucose values following 75 gm glucose intake are calculated. At the time of collection of fasting glucose sample, fasting lipid profile is also done. Height and weight of the antenatal mother at this point of time also recorded using standard scale and BMI is calculated. Those patients with negative OGTT are advised routine antenatal care. Those patients with positive OGTT are referred to endocrinologist and dietician for multidisciplinary management. They are further classified into those on diet control, insulin, OHA s and both insulin and OHA. When the patient gets admitted for delivery, the mode of delivery, Gestational age, gestational weight gain, offspring birth weight and maternal and perinatal outcome will be analysed.
MATERIALS:
All biochemical tests will be analyzed with COBAS 6000 Rocha analyzer.
OGCT and OGTT: Plasma venous blood is used and analyzed by hexokinase method.
Total cholesterol: Serum sample is taken and analyzed by oxidase / peroxidase method.
Triglycerides: Serum sample is taken and analyzed by Glycerol phosphate method
PLAN FOR DATA ANALYSIS – Collected data will be revised by mean, standard deviation, frequency, percentage, Karl Pearson coefficient, ‘t’ test and by Chi square test. Software :
INCLUSION CRITERIA:
Antenatal mothers with positive OGCT in any period of gestation.
EXCLUSION CRITERIA:
· Women with pre gestational diabetes mellitus or on treatment of DM.
· Women with hypertensive disorder and pre eclampsia at the time of registration.
· Women with thyroid disorders, lupus and APLA
· Subjects who delivered < 37 wks, fetal or congenital malformations and multifoetal gestations.
7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTIONS TO BE CONDUCTED ON PATIENT OR OTHER HUMAN OR ANIMALS?
Yes
Oral glucose challenge test to be done to antenatal mothers as universal screening. Those with elevated OGCT values have to undergo OGTT test. At the time of collection of fasting glucose sample, Serum triglycerides and total cholesterol samples also collected. BMI of mothers also calculated.
7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3?
Yes
8 / LIST OF REFERENCES:
1. Emilio Herrera Ph.D, Henar Ortega-senovilla, Ph.D Disturbances in lipid metabolism in diabetic pregnancy-are these the cause of the problem?;Best practice and research clinical endocrinology and metabolism 24(2010) 515-525.
2. Kathy white, Hannah Kelly, Vicky O’ Dwyer, Michelle gibbs, Amy O’Higgins, Michael J. Turner; Offspring birth weight and maternal fasting lipids in women screened for GDM; European journal of obstetrics and gynecology 2013;8077.
3. Schaefer-Graf UM, Graf K, Kulbacka et al. Maternal lipids as strong determinants of fetal environment and growth in pregnancies with gestational diabetes mellitus, Diabetes care 2008;31:1858-63 .
4. Hyun Son GA, Young Kwon JA, Young Han K, Yong Won P. Maternal serum triglycerides as predictive factors for large for gestational age infants with gestational diabetes mellitus. Acta Obstet Gynecol 2010;89:700-4.
5. Vrijikotte TGM, Algera SJ, Brouwer IA, van Ejisden M , Twickler MB. Maternal triglyceride levels during early pregnancy are associated with birth weight and postnatal growth. J Pediatr 2011;159:736-742.
6. Koukkou E, Watts GF, Lowy C. Serum lipid, lipoprotein and apolipoprotein changes in gestational diabetes mellitus: a cross sectional and prospective study. J Clin Pathol 1996;49: 634-7.
7. Knopp RH, Magee MS, Walden CE, Bonet B, Benedetti T.J Prediction of infant birth weight by GDM screening tests. Importance of plasma triglyceride. Diab care 1992;15: 1605-1613.
8. Kitajima M et al , Maternal serum triglyceride at 24-32 wks and gestational and newborn weight in nondiabetic women with positive diabetic screens. Obstet gynecol 2001;97:776-780.
9. Schwartz R et al, Hyperinsulinemia and macrosomia in fetus of diabetic mother. Diabetes care 1994; 17: 640-648.
10. Knopp RH et al. Lipoprotein metabolism in pregnancy Perinatal biochemistry. Boca raton: CRC press,1992,pp 19-51.
11. Diamant Y Z et al 1982.Placental glycogen and lipid content in human and experimental diabetes mellitus .AM . J Obstet and Gynecol 144:5-11
9. / SIGNATURE OF THE CANDIDATE:
10. / REMARKS OF THE GUIDE:
11. / NAME AND DESIGNATION OF THE
11.1 GUIDE: / DR.NAGARATHNA.G
MS (OBG)
PROFESSOR
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY,
FATHERMULLER MEDICAL COLLEGE
KANKANADY,
MANGALORE-575002
11.2 SIGNATURE :
11.3 CO-GUIDE: / DR SUDEEP K, ENDOCRINOLOGIST, DEPARTMENT OF MEDICINE, FATHER MULLER MEDICAL COLLEGE.
11.4 SIGNATURE:
11.5 HEAD OF THE DEPARTMENT: / DR PREMA D’CUNHA
MS (OBG)
PROFESSOR AND HOD,
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY,
FATHERMULLER MEDICAL COLLEGE
KANKANADY,
MANGALORE-575002
11.6 SIGNATURE:
12. / 12.1REMARKS OF THE CHAIRMAN & PRINCIPAL:
12.2SIGNATURE;
COST OF THE PROJECT
For All Antenatal mothers GCT is done as a routine screening test. For all GCT positive mothers should undergo GTT, which also is routine.
For GTT positive mothers, Serum Triglycerides and Serum Cholesterol have to be done for this study, the cost for which is:
Serum triglycerides: Rs. 65
Serum Cholesterol: Rs. 65
The sample size for this study is a Minimum of 50 subjects; hence the total expenditure will amount to minimum of Rs. 6500.
I have applied for RGUHS funding which provides 50% of the amount for Laboratory test and is under process.
WRITTEN INFORMED CONSENT
I …………………………………….(name) of age………. consent to be a part of the study “OFFSPRING BIRTH WEIGHT AND MATERNAL FASTING LIPIDS IN WOMEN SCREENED FOR GESTATIONAL DIABETES MELLITUS” conducted by Dr Janaki Menon C.M under the guidance of Dr Nagarathna .G and Dr.Sudeep.K in Father Muller Medical College.
I have been explained that the study is only of diagnostic significance and has no therapeutic implications. The risks involved in the study are explained to me. I hereby consent to be a part of the study.
Consenter’s signature.
Date:
Place:
Witness signature.
Date:
Place:
Name of the guide: Dr.Nagarathna .G
Name of the Co-guide: Dr.Sudeep.K
Name of the investigator: Dr. Janaki Menon C.M
Address: Post Graduate Resident,
Dept. of Obstetrics and Gynaecology,
Father Muller Medical College,
Kankanady ,Mangalore - 575002
9