SRI RAMACHANDRA UNIVERSITY

Initial Review Submission Form for Research Proposal

TITLE

MATERNAL AND FETAL OUTCOMES IN PREGNANT

WOMEN ON METFORMIN – AN OBSERVATIONAL STUDY

DR.R.SAMBAVI LAKSHMI
PRINCIPLE INVESTIGATOR

FIRST YEAR POST GRADUATE

DEPARTMENT OF OBSTETRICS AND GYNECOLOGY

SRI RAMACHANDRA UNIVERSITY

DR.JAYA VIJAYARAGHAVAN
THESIS GUIDE

PROFESSOR OF OBSTETRICS AND GYNECOLOGY

DEPARTMENT OF OBSTETRICS AND GYNECOLOGY

SRI RAMACHANDRA UNIVERSITY

 DR.USHA RANI
HEAD OF DEPARTMENT

DEPARTMENT OF OBSTETRICS

SRI RAMACHANDRA UNIVERSITY

CHECKLIST :

1. Protocol is complete Yes

2. Objectives clearly defined Yes

3. Methodology is described in detail Yes

4. The proposed methods will answer the research question Yes

5. Statistical method for sample size estimation/analysis spelt out Yes

6. Informed consent Yes

Patient information sheet and informed consent forms are
attached (English and regional language)

7. If children <18 years consent from parent/guardian NA

(Assent form from children 12-18 years)

8. Forwarding letter from the HOD and the guide Yes

9. Consent letter from other departments, if applicable Yes

 10.Ethical issues addressed Yes

11.Relevant proforma/case record form attached Yes

12.Brief CV of the PI/Guide attached Yes

1. Brief CV of the Co-PI if applicable attached

Signature of the guide with date

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

• Metformin versus Insulin for the Treatment of Gestational Diabetes

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

• To study the maternal and fetal outcomes in pregnant women on metformin

• To assess the association of metformin intake and incidence of gestational diabetes

mellitus in non diabetic antenatal women

MATERIALS & METHODOLOGY :

• Study design : Prospective observational study

• Study period : October 2017 – October 2019

• Study place : Depatment of OBG , SRMC

• 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

• GROUP 1 : includes AN women with PCOS,obesity who are on metformin

preconceptionally.

-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

- Fetus AC > 90 th centile & Estimated fetal weight

• 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

• To assess whether metformin adequately control blood sugars.

• To assess the effect of metformin on adverse pregnancy outcomes like pregnancy

induced hypertension, postpartum hemorrhage,fetal macrosomia , cesarean section
,admission to ICU and neonatal complications like hyperbilirubinemia , hypoglycemia ,
NICU admission , respiratory distress syndrome.
 PROFORMA

MATERNAL AND FETAL OUTCOMES IN PREGNANTWOMEN ON METFORMIN

 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

 H/O GDM IN PREVIOUS PREGNANCY

 H/O LGA BABY IN PREVIOUS PREGNANCY
 H/O PCOD
 PREVIOUS H/O INTAKE OF METFORMIN
 H/O PIH IN PREVIOUS PREGNANCY
 H/O CHRONIC HYPERTENSION IN PREVIOUS PREGNANCY
 FAMILY HISTORY OF DIABETES

 GESTATIONAL AGE OF START OF TREATMENT WITH METFORMIN

 DURATION OF TREATMENTWITH METFORMIN
 ADDITIONAL USAGE OF INSULIN – YES / NO

 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

OVERT DM / GDM ON METFORMIN

 6 VALUE CBG
DATE B.B A.B B.L A.L B.D A.D

 FBS , PPBS VALUES

DATE FBS PPBS

 GROWTH SCAN
GESTATIONAL AGE AC EFW
28 WK
32-36 WK

MATERNAL OUTCOME VARIABLES

 VARIABLES YES NO
THREATENED ABORTION

UTI

VULVAL INFECTION

GESTATIONAL HYPERTENSION

PRE ECLAMPSIA

GDM

PPROM

PROM

POLYHYDRAMINOS

PRE TERM LABOUR

KETOACIDOSIS

GLYCEMIC CONTROL

ECG

FUNDUS EXAMINATION –
DIABETIC RETINOPATHY

INDUCED LABOUR

ASSISTED LABOUR

GENITAL TRACT INJURY

SHOULDER DYSTOCIA

POST PARTUM HEMORRHAGE

WEIGHT GAIN DURING ENTIRE PREGNANCY –

GTT AFTER 6 WEEKS -

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

APGAR SCORE <7 AT 5 MIN

NEONATAL DEATH
 INFORMED CONSENT
MATERNAL AND FETAL OUTCOMES IN PREGNANT WOMEN ON METFORMIN – OBSERVATIONAL STUDY

I Mrs.____________________________ w/o Mr._______________________________ residing at

_____________________________________________________________________________________
_____________________________________________________________________________________

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.

Contact Address with phone number:

 PI from SRMC Colloborator (if any ) from SRMC :

Dr.R.Sambavi Lakshmi

First year Post graduate

Department of obstetrics & gynecology

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.

Date: Signature of person obtaining consent :

Name:

Signature of PI
(forwarding letter from HOD )

From

Prof. Usha Rani. G

Professor& HOD
Department of Obstetrics and gynecology
Sri Ramachandra University
Porur, Chennai-116.

To
The Ethics Committee
Sri Ramachandra University
Porur, Chennai-116.

Subject: HOD forwarding letter

Respected Sir,

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

Professor & HOD

Department of Obstetrics & Gynecology

SRMC
 CURRICULUM VITAE

Name : Dr.Jaya Vijayaraghavan

MBBS., D.G.O., M.D., FICOG, FICS

Date of Birth : 10th February 1957

Nationality : Indian

Address for Communication : S2, Triple ‘C’ Majesty,

48/6, Muthukumarappa Street,

Saligramam, Chennai – 600 093.

Phone: 044 23760062

Mobile: 9840239891

Marital Status : Married

Languages Known : English, Hindi, Gujarati, Tamil, Kanada

EDUCATIONAL QUALIFICATION:

S.No Degree / University / Institution Year of joining

Certificate Board / passing
 1. MD (OBGYN.) Gujarat University B.J.Medical College, 1981 – 1983
Ahmedabad, India

2. D.G.O Gujarat University B.J.Medical College, 1981 – 1982

Ahmedabad, India

3. M.B.B.S Gujarat University B.J.Medical College, 1975 – 1979

Ahmedabad, India

4. FICOG India College of Obst & 2000

Gynaecologist

5. FICS Fellow of International 2007

College of Surgeon

PRESENT STATUS: Professor of OBGYN, Sri Ramachandra University, Chennai.

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:

S.No Position held Institute From To UG PG

teaching teaching

1. Prof. & HOD Dept. SRMC & RI Feb. Aug. 2007

of OBGYN. 2001
Chennai.

2. Prof. of OBGYN. SRMC & RI Aug.2000 Feb. 2001

Chennai.
 3. Assoc. Prof. of SRMC & RI Nov. Aug. 2000
OBGYN. 1994
Chennai.

4. Asst. Prof. of SRMC & RI Feb. Nov. Total

OBGYN. 1989 1994. 20years
Chennai.

5. Medical Officer HAL Bangalore Dec. Feb 1989 Teaching

HAL Bangalore 1985 DNB – OG
Students

6. Lecturer MS Ramaiah Aug. Dec. 1985

Bangalore 1985

7. Consultant /Obst. / Pvt. Nursing Feb. Aug. 1984 Total

Gynaec Home 1984 14years
Bangalore

8. Resident (OBGYN.) B.J.M.C Jan. Dec. 1981

Ahmedabad 1981

CLINICAL WORK:

 Have been Incharge of Unit since January 1994

 Doing all major Gynaec, Obstetrics, Emergency, Oncology and Laparoscopy work.

ACADEMIC WORK:

 Teaching & training of undergraduates and postgraduates

 Guiding one M.S. postgraduate / year on dissertation. Totally 16pgs guided so far.
 Guiding 4 PhD students
 Been undergraduates and postgraduates examiner for MBBS, MS and Dip. NB
 Been as undergraduate examiner to Gulf Medical College.
 Chaired session, delivered guest lectures in various conference
 Conducted revision courses and workshops.
BRIEF RESUME

I have published 17 national level and 2 international journals.

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.

MEMBERSHIP: (PROFESSIONAL BODIES) (Life Member)

Indian Medical Association

1. Obstetric and Gynaecology Society of Southern India (OGSSI)

2. Federation of Obstetric and Gynaecology Society of India (FOGSI)
3. Member of Indian Menopause society
4. Urogynaecology Society of India
5. Gynaecological oncology society of India

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

1. Use of progesterone gel in woman with previous history preterm labour

2. Use of progesterone gel in woman with short cervic two other trial on fibroid and
theraterned abortion have been approved and awaiting DCGI and Ethics committee
approval respectively.
ARTICLES IN MAGAZINES:

 Questconing the C Cut – Modern Medicare – Volume, 8th July 2005

 Health Today (Tamil) Emergency contraception January 2005.
 Given health talks in some of the famous Tamil channels
REFERENCES:

Prof.T.K.Parthasarathy
Pro – Chancellor

Sri Ramachandra Medical College & Research Institute

Sri Ramachandra University,

Porur, Chennai – 600 116.

Prof.Savitri Subramanyam, M.D., D.G.O.F.I.C.O.G

Sri Ramachandra Medical College & Research Institute

Sri Ramachandra University,

Porur, Chennai – 600 116.

BIOGRAPHICAL SKETCH

Name Title BIRTH DATE

(Month, Day, Year)
DR.R.SAMBAVI LAKSHMI MBBS APRIL,11,1993.

EDUCATION

INSTITUTION AND LOCATION DEGREE (UG/PG) YEAR FIELD OF STUDY

CONFERRED

MADRAS MEDICAL
COLLEGE UG 2010 - 16
DR.MGR Medical University

TEACHING & RESEARCH EXPERIENCE

Institute From To Designation

Principal investigator

SAMBAVI LAKSHMI . R

POST GRADUATE
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY,
SRU.
Address: 9 B 1 LAKSHMI COLONY ,

DHARMAPURI ,

TAMIL NADU - 636701

Mobile no.: 8903508906

Permanent Registration number:118018

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

Mother Tongue: Tamil

Languages Known: Tamil, English

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

I st year MS(OG) POSTGRADUATE

Department of Obstetrics and Gynaeocolgy.,
SRMC.

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.