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TITLE
DR.R.SAMBAVI LAKSHMI
PRINCIPLE INVESTIGATOR
DR.JAYA VIJAYARAGHAVAN
THESIS GUIDE
DEPARTMENT OF OBSTETRICS
CHECKLIST :
BACKGROUND :
• Globally the incidence and prevalence of diabetes is increasing worldwide.Further diabetes
mellitus occurs at an young age in the indian population. This is attributed to lifestyle changes ,
obesity , metabolic syndrome , PCOS etc. This has lead to an increase in GDM in pregnant
women.
• The overall prevalence of GDM in INDIA ranges from 15-20% with the prevalence of GDM in
tamilnadu is 17 %.
• This create a state of hyperglycemia and insulin resistance which has an adverse outcome both
on the mother and fetus. Metformin a biguanide drug helps in improving the glucose
intolerance by decreasing the hepatic gluconeogenesis and increased peripheral utilization of
glucose. Thereby the amount of glucose load to the fetus is decreased and preventing the fetus
from developing hyperinsulinemic state and macrosomia
PARENT ARTICLE :
• EFFECT OF METFORMIN ON MATERNAL AND FETAL OUTCOMES IN OBESE PREGNANT WOMEN (
EMPOWAR ) : A RANDOMISED DOUBLE BLIND, PLACEBO – CONTROLLED TRIAL
Carolyn chiswick,Rebecca M Reynolds,Fiona Denison,Amanda J Drake,Shareen Forbes,David E
Newby,Prof.Brian R Walker,Prof.Susan Wray ,Prof.Andrew weeks,Hany Lashen ,Aryelly
Rodriguez,Gordon murray,Sonia Whyte,Jane E Norman
Janet A. Rowan, M.B., Ch.B., William M. Hague, M.D., Wanzhen Gao, Ph.D., Malcolm R. Battin, M.B.,
Ch.B., and M. Peter Moore, M.B., Ch.B.
OBJECTIVES :
• To study the effect of metformin in pregnant women
• Study Population : All pregnant women on metformin during pregnancy for obesity /
PCOS / GDM / Overt DM /Type 2 DM diagnosed prior to pregnancy
• Inclusion criteria :
All pregnant women on metformin and planning to deliver in SRMC and willing
for a follow up for 6 weeks
• Questionanaire
-Biochemical tests : GTT 75 gm glucose -2 hr PPBS value done in First trimester , 24-28
wks , 30-34 wks
(GDM diagnosed based on DIPSI criteria)
• GROUP 2 : diagnosed to be overt DM and who are diagnosed to be GDM and started on
metformin
- Frequent monitoring of blood sugar for glycemic control (based on 6 value CBG or FBS ,
PPBS depending on the glycemic control)
• USG growth scan done at 28 weeks and 34 weeks for both the groups
• Considering the prevalence of GDM and adverse maternal outcomes with p = 20 % the
sample size is calculated as
N = (Z)(Z) p q / (L)(L)
N = 384
EXPECTED OUTCOMES :
• To assess whether metformin reduces the incidence of GDM in obese pregnant women
NAME
AGE / SEX
ADDRESS
CONTACT NO
HEIGHT
PRE PREGNANCY WEIGHT
BMI
PARITY – PRIMI / MULTIPARA / GRAND MULTIPARA
BLOOD PRESSURE AT THE TIME OF ENROLMENT
CONCEPTION – SPONTANEOUS / OVULATION INDUCTION / IVF
SINGLETON / MULTIPLE PREGNANCY
HBA1C
DATE VALUE
RFT
LFT
GROUP 1 :
GTT 75 gm glucose
PCOS , OBESE (BUT NOT A K/C/O TYPE 2 DM) ON METFORMIN
First trimester
24-28 wks
30-34 wks
GROUP 2
GROWTH SCAN
GESTATIONAL AGE AC EFW
28 WK
32-36 WK
UTI
VULVAL INFECTION
GESTATIONAL HYPERTENSION
PRE ECLAMPSIA
GDM
PPROM
PROM
POLYHYDRAMINOS
KETOACIDOSIS
GLYCEMIC CONTROL
ECG
FUNDUS EXAMINATION –
DIABETIC RETINOPATHY
INDUCED LABOUR
ASSISTED LABOUR
SHOULDER DYSTOCIA
0 HR 2 HR
FETAL OUTCOMES
VARIABLES YES NO
CONGENITAL ANOMALIES
PREMATURITY
MACROSOMIA
IUD
NEONATAL HYPOGLYCEMIA
HYPOCALCEMIA
RESPIRATORY DISTRESS
SYNDROME
BIRTH TRAUMA
NICU ADMISSION
HYPERBILIRUBINEMIA
NEONATAL DEATH
INFORMED CONSENT
MATERNAL AND FETAL OUTCOMES IN PREGNANT WOMEN ON METFORMIN – OBSERVATIONAL STUDY
hereby declare that I give voluntary consent in this prospective observational study - ‘ MATERNAL AND
FETAL OUTCOMES IN PREGNANT WOMEN ON METFORMIN ‘
I have ben explained in a language best understood by me about the nature of the study and that
participation is completely voluntary and no payment is involved.
I have been explained Tab.metformin would have been started prior to pregnancy for insulin resistance,
Polycystic ovarian syndrome or the drug would have been started once GDM has been diagnosed during
pregnancy.
I have been explained about the problems of metformin like gastritis and GDM like abortions , UTI,
vulval infection, big baby , pregnancy induced hypertension ,early induction of labour , cesarean section
in view of big babies and neonatal complications like hypoglycemia , hyperbilirubinemia , respiratory
distress syndrome , NICU admission.
I have been explained I will be followed up for a period of six weeks postpartum and that GTT will be
performed for those diagnosed to be DM during pregnancy.
I have been informed that the information obtained will be strictly confidential and I give full consent for
the enrolment in the study and I reserve my right to withdraw from the study whenever I wish without
prejudice of my right to undergo further treatment at Sri Ramachandra hospital.
I have read this consent form (or it has been read to me) and I fully understand the contents of this
document and voluntarily consent to participate in the study. All of my questions concerning this study
have been answered. If I have any questions in the future about this study they will be answered by the
investigators listed below. I understand that this consent ends at the conclusion of this study.
Dr.R.Sambavi Lakshmi
SRMC.
[In case of illiterate participant, the information is explained and thumb impression is obtained, in the
presence of an unrelated witness. Left hand thumb impression for male and right hand thumb
impression of female]
By signing this form, I agree to participate in this study. A copy of this form has been given to me.
Date: Name:
Participant’s signature
Thumb impression
Witness name
Witness signature
CERTIFICATION OF INFORMED CONSENT
I certify that I have explained the nature and purpose of this study to the above-named individual, and I
have discussed the potential benefits of this study participation. The questions the individual had about
this study have been answered, and we will always be available to address future questions.
Name:
Signature of PI
(forwarding letter from HOD )
From
To
The Ethics Committee
Sri Ramachandra University
Porur, Chennai-116.
This is to certify that Dr.R.Sambavi Lakshmi is doing her M.S thesis on the
“MATERNAL AND FETAL OUTCOMES IN PREGNANT WOMEN ON METFORMIN
– AN OBSERVATIONAL STUDY”.This study is done in Department of Obstetrics and
Gynecology and I am aware of the same.
Thanking you ,
Yours sincerely ,
Dr.Usha Rani
SRMC
CURRICULUM VITAE
Nationality : Indian
Mobile: 9840239891
EDUCATIONAL QUALIFICATION:
ADMINISTRATION:
1. Head of the Department of OBGYN. at Sri Ramachandra University from February 2000 to
August 2007.
2. Member of MSEC and Transfusion Committee
POSITION HELD:
Chennai.
3. Assoc. Prof. of SRMC & RI Nov. Aug. 2000
OBGYN. 1994
Chennai.
CLINICAL WORK:
ACADEMIC WORK:
I have delivered guest lectures in various state, zonal and national level conferences. I have also
had 70 scientific paper presentations. I have 12 workshops conducted.
SPECIAL TRAINING:
1. Worked in anaesthesiology for 3months at civil hospital, Ahmedabad, India during 2nd year
residency MD course.
2. Worked in cancer gynaecology for 3months in MP Shah Cancer Institute, Ahmedabad,
India during 2nd year residence MD course.
3. Trained in laporoscopy both diagnostic and operative (TL)
4. Underwent training in Trasn vaginal ultrasound at Apollo Hospitals
5. Underwent observership at Antenatal diagnositic centre, NUH Singapore
6. Training in Operative Laparoscopy
7. Trained in ICH-GCP guidelines for research
RESEARCH
Prof.T.K.Parthasarathy
Pro – Chancellor
EDUCATION
MADRAS MEDICAL
COLLEGE UG 2010 - 16
DR.MGR Medical University
SAMBAVI LAKSHMI . R
POST GRADUATE
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY,
SRU.
Address: 9 B 1 LAKSHMI COLONY ,
DHARMAPURI ,
Education:
MBBS: MADRAS MEDICAL COLLEGE , CHENNAI - 600003
Higher Secondary:
SRI VIDYA MANDIR MATRICULATION HIGHER SECONDARY SCHOOL , UTHANGARAI ,
KRISHNAGIRI .
Personal Profile:
Nationality: Indian
Age/Gender: 24/Female
DOB: 11/04/1993
PROFESSIONAL MEMBERSHIP
OGSSI
I hereby declare that the Information furnished above is true to the best of my knowledge and belief.
Place: Chennai
Date:
DR.R.SAMBAVI LAKSHMI
To
The Ethical Committee
SRMC.,
Porur
Chennai.
Respected Sir/Madam,
I herewith submit the topic of my thesis for the curriculum as MATERNALAND FETAL
OUTCOMES IN PREGNANT WOMEN ON METFORMIN – AN OBSERVATIONAL
STUDY . I shall be doing the research for the year 2017-2019, in the Department of Obstetrics
and Gynaecology under the guidance of Dr.Jaya Vijayaraghavan .
Thanking You,
Yours sincerely ,
Dr.R.Sambavi Lakshmi.