Project

Title

TO STUDY PERINATAL OUTCOME IN THYROID DISORDER IN

PREGNANCY

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I
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1

IEC Agenda & Minutes of Meeting Noting Page 1

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Acknowledgment Form
Project
Title

TO STUDY PERINATAL OUTCOME IN THYROID DISORDER IN

PREGNANACY
4

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Names

THESIS
THYROID DISORDER IN PREGNANCY
TO STUDY PERINATAL OUTCOME IN THYROID
DISORDER IN PREGNANCY
DR.DEEPIKA SHARMA
DR. ARUN. H . NAYAK

Sponsor Name *

NA

Checked and Complete #

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Brief Curriculum Vitae of Principal Investigator

Name
First Name
Dr.DEEPIKA

Last Name
SHARMA
7

Present position with work address

Position
Post graduate Student
Dept. of OBGY
Name of institution or organization:
LokmanyaTilak Municipal Medical college
& General
Hospital
Start date (at least year):

Street address or postal address

RMO QTRS.
LTMGH
SION
City & postal/zip code:
Mumbai -400022
Country:
India

Main University Degree(s)

Name of university/institute:
MAHARASHTRA UNIVERSITY OF
HEALTH SCIENCES
City & country:
MUMBAI,INDIA

Degree awarded:
MBBS
Year of graduation:
2014

Professional Training- None

Registration/Medical License number (where applicable) MP15552

Previous Appointments
Position:
STUDENT
Institution/organization:
LokmanyaTilak Municipal Medical college
& General
Hospital

Dates:
City & country:
MUMBAI, INDIA

Covering Letter
To,
The Chairperson,
Institutional Ethics Committee (Human Research),
8

L.T.M.M.C. & L.T.M.G.H.,

Sion, Mumbai-400 022.
Subject: Submission of Clinical Study Documents for sponsored for your review and approval.
Sir/Madam,
I request you to kindly accept my application for the project TITLETO STUDY PERINATAL
OUTCOME IN THYROID DISORDER IN PREGNANCY which is single center study, so as to
enable me to conduct the referenced research project at Lokmanya Tilak Municipal Medical
College & General Hospital, Sion, Mumbai, if granted permission by the Institution Ethics
Committee. I will be responsible towards the co investigators for this project. The total number
of patients that is proposed to be enrolled is 50 over a period of 2 years which will be feasible at
the LokmanyaTilak Municipal Medical College & General Hospital, Sion, Mumbai in the above
period. The total number of patients planned to be enrolled for this center is 50
Please find enclosed herein following documents for your review and approval.
I would be happy to offer any other information or clarification as may be required by you
Thanking you.

Dr. DEEPIKA SHARMA

Post Graduate Student
Dept. of Obst&Gyn
Mobile No.7506587897
L.T.M.Medical &L.T.M.G. Hospital,
Sion, Mumbai 400 022

Joint Undertaking by Principal Investigator and Sponsor

To,
9

The Staff & Research Society

LTMG Hospital & Medical College,
Sion, Mumbai
Subject: Joint Undertaking to the Staff & Research Society
Sir / Madam,
I promise to collect the Project Clearance Letter within 7 working days once the project is
cleared by the Institutional Ethics Committee and promise to initiate the project within 1 month
of the receipt of the Project Clearance Letter
I also promise to pay the full dues with respect to the Staff & Research Society, LTMG
Hospital & Medical College as per the project estimate within 7 days of acceptance of Project
Clearance Letter issued by the Institutional Ethics Committee.
Thanking you.

DR.DEEPIKA SHARMA

Post Graduate
Dept. of Obst & gynae
Mobile No.7506587897
L.T.M.Medical College &
L.T.M.G. Hospital,
Sion, Mumbai 400 022.

10

Project Index Page

Project Index Page
Project
Title

TO STUDY PERINATAL OUTCOME IN THYROID DISORDER IN

PREGNANCY

Index

No Document Name
Page
( Please specify in Page Nos column NA if not Nos.
applicable )

Research Project Format *

Project Summary *

Research Protocol Application Format *

References *

Patient Information Sheet in 3 languages *

Patient Informed Consent Form in 3 languages *

Case Record Form / Questionnaire / Patient Diary

*

Additional Documents ( As may be required )

Investigator Brochure for Sponsored project

Clinical Trial Agreement

Insurance Policy with suitable validity

DGCI Approval Letter for Phase I/ II/ III study

Investigators undertaking to DCGI (for Phase I,

II, III, studies)

Ethics
Committee
Clearance
/status
( Multicentric / Multinational study only ) Letter
from Ethics Committee / Letter from Sponsor for
status

Food and Drug Administration (FDA)

marketing/manufacturing license for herbal drugs.

**Please specify if Clearance of other Bodies as

may be required ( Sample List enclosed below )

Project Completion Letter *

* Mandatory

PI
Check
Chk ( SRS
use )

Project Summary

11

Abbreviated Project Title: THYROID DISORDER IN PREGNANCY

Project title : TO STUDY PERINATAL OUTCOME IN THYROID DISORDER IN
PREGNANACY
Sponsored Study

Not Sponsored Study

Name & Address of Sponsor ( If sponsored )

Estimated Duration of the project

I / we understand that the sanction will be granted for one year only at a time and only on
submission of the Trial report along with communication of for extending the duration of
the project further as per the estimated Time of the project shall the project be allowed to
continue after 1 year.
1. Type of Study :

Prospective
Single center

Retrospective
Multicenter

Multinational
No. of centers________________
2.Does the study involve use of :

Drug NA

Any Other

NA

If other, please specify_________________________

Not Applicable
i) Is the test drug/device marketed in India
Is marketed in other countries:

Yes

No

Yes

No

Please Specify_________________
If not marketed in India, is DCG(I) permission attached . Yes
In Additional Documents Chapter On Page no ____
ii) Is the test drug an Investigational New Drug(IND)?
If yes, is the Investigators Brochure which contains
data of pre-clinical studies attached.
In Additional Documents Chapter On Page no ____
If IND, is attach DCG(I) permission.
In Additional Documents Chapter On Page no ____

Yes
Yes
Yes

No

No
No
No

12

iii) Does the test drug involve a change in use, dosage,

route of administration?
If yes, is copy of DCG(I) permission attached
In Additional Documents Chapter On Page no ____
3. Clinical Study is :
Phase IV

NA

Phase I

Phase II

Yes

No

Phase III

4. Subject Selection :
i) Number of subjects at this centre
ii) If multicentric,

50

Total number of subjects

iii) If multinationational , Total number of Subject In Indian Centres

__NA_____
__NA___

Total Number of patients in all centres

_______

iv) Vulnerable subjects:

Yes
No
(If yes, circle the correct options)
Pregnant women
Children
Elderly
Fetus
Illiterate
Handicapped
Seriously/terminally
Mentally challenged
Economically/socially backward
Any other
If other, please specify_________________________________________________
v) Special group subjects: Yes
No
(If yes, circle the correct
options)
Employees
Students
Nurses/dependent staff
Any other
If other, please specify ________________________________________________
5.Does the study involve use of
i) fetal tissue or abortus

Yes

No

ii) organs or body fluids

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

iii) recombinant/gene therapy

If yes, is copy of GEAC permission permission attached
In Additional Documents Chapter On Page no
____
iv) ionizing radiation/radioisotopes
If yes, is copy of BARC permission permission attached
In Additional Documents Chapter On Page no
____
v) Infectious/biohazardous specimens
vi)Will pre-existing/stored/left over sample be used?

13

vii)Will samples be collected for banking/future research

Yes

No

viii)Will any sample collected from patients be sent abroad?

Yes

No

If yes, is copy of DGFT approval /permission attached

In Additional Documents Chapter On Page no ____
ix)Is there any collaboration with any foreign lab., clinic or
hospital?

Yes

No

Yes

No

If yes, is copy of HMSC approval / permission attached

In Additional Documents Chapter On Page no
____
6. Will any advertising be done for recruitment of Subjects?
(Posters, flyers, brochures, etc.)
If yes, is a copy for IEC(HR) review

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

In Additional Documents Chapter On Page no

____
7. Data Monitoring
i)Is there a separate data & safety monitoring board (DSMB)?
ii)Is there a plan for interim analysis of data?
iii)For how long will the trial data be preserved?

_________years

8. Is there compensation for participation?

If yes,

Monetary

Yes

No

In kind

Specify amount/type:___________________________________
9. Is there any arrangement for compensation for trial related injury?
No

Yes

If yes, is copy of HMSC approval / permission attached

Additional Documents Chapter On Page no ____
We hereby declare the information given above to be true and that we do not have any
financial or non-financial conflict of interest.

Dr.DEEPIKA SHARMA

Post Graduate
Dept. of Obst&Gyn
14

L.T.M.M. College &

L.T.M.G. Hospital,
Sion, Mumbai 400 022

Research Protocol Application

Abbreviated Project TITLETHYROID DISORDER IN PREGNANCY

Project Title

TO STUDY PERINATAL OUTCOME IN THYROID DISORDER IN PREGNANCY

Principal Investigator Name

Dr.DEEPIKA SHARMA
Post Graduate
Dept. of Obstetrics & Gynaecology

15

Co Investigator Name / Co Investigators Names

DR.ARUN.H.NAYAK
PROFESSOR & HEAD OF UNIT
Dept. of Obstetrics and Gyanecology
LTMGH & LTMMC

Introduction and Background of the proposed project:

HYPOTHYROIDISM IN PREGNANCY

Maternal thyroid function changes during pregnancy and inadequate adaptation to these
changes results in thyroid dysfunction. Some of these alterations in thyroid function
occur due to increased thyroid hormone-binding globulin (TBG) concentration, increased
iodine clearance in the kidneys, and thyrotrophic effect of human chorionic gonadotropin
(HCG). In previous studies, the prevalence of overt hypothyroidism was 1% to 1.5%, and
prevalence of subclinical hypothyroidism was 5% to 8%
Hypothyroid women are more likely to experience infertility, and they have an increased
prevalence of abortion, anemia, gestational hypertension, placental abruption, and
postpartum haemorrhage low-birth weight (LBW), fetal distress in labor, fetal death, and
congenital hypothyroidism, and neurocognitive deficits in children. Subclinical
hypothyroidism might be associated with preterm delivery and low Apgar score .
Untreated maternal overt hypothyroidism is associated with adverse neonatal outcomes
including premature birth, low birth weight, and neonatal respiratory distress. There may
be more fetal and perinatal death, and gestational hypertension may also contribute to the
overall increase in neonatal risks. Women with gestational SCH were found in one study
to have more preterm deliveries , and the offspring have more admissions to neonatal
intensive care and an increased rate of respiratory distress syndrome ( Even maternal
16

TSH levels in the upper normal range are associated with increased fetal loss, as
compared with lower normal levels .
Universal screening of healthy women for thyroid dysfunction before pregnancy is not
recommended.
However, caregivers should identify individuals at high risk for thyroid illness on the
basis of their medical history, physical exam, or prior biochemical data. When such
individuals are identified, prenatal measurement of serum TSH is recommended. If it is
above 2.5 mIU/liter, the test should be confirmed by repeat assay. Although no
randomized controlled trials are available to guide a response, the committee believes it is
appropriate to give low-dose T4 treatment to bring TSH below 2.5 mIU/liter. This
treatment can be discontinued if the woman does not become pregnant or postpartum
If hypothyroidism has been diagnosed before pregnancy, we recommend adjustment of
the preconception T4 dose to reach before pregnancy a TSH level not higher than 2.5
mIU/liter.
The T4 dose usually needs to be incremented by 4 to 6 wk gestation and may require a
30% or more increase in dosage.
If overt hypothyroidism is diagnosed during pregnancy, thyroid function tests should be
normalized as rapidly as possible. T4 dosage should be titrated to rapidly reach and
thereafter maintain serum TSH concentrations of less than 2.5 mIU/liter (in an assay
using the International Standard) in the first trimester (or 3 mIU/liter in second and third
trimesters) or to trimester-specific TSH ranges. Thyroid function tests should be re
measured within 3040 d and then every 46 wk.
Women with thyroid autoimmunity who are euthyroid in the early stages of pregnancy
are at risk of developing hypothyroidism and should be monitored every 46 wk for
elevation of TSH above the normal range for pregnancy
HYPERTHYROIDISM IN PREGNANCY
For overt hyperthyroidism due to Graves' disease or thyroid nodules, antithyroid drug
(ATD) therapy should be either initiated (before pregnancy if possible, and for those with
new diagnoses) or adjusted (for those with a prior history) to maintain the maternal
thyroid hormone levels for free T4 at or just above the upper limit of the non pregnant
reference range, or to maintain total T4 at 1.5 times the upper limit of the normal
reference range or the free T4 index in the upper limit of the normal reference range.
thyroid function should be assessed after 2 wk and then at 2- to 4-wk intervals
Because thyroid receptor antibodies (thyroid receptor stimulating, binding, or inhibiting
antibodies) freely cross the placenta and can stimulate the fetal thyroid, these antibodies
should be measured by 22 wk gestational age in mothers with: 1) current Graves' disease;
or 2) a history of Graves' disease and treatment with 131I or thyroidectomy before
pregnancy; or a previous neonate with Graves' disease; or previously elevated TRAb.
17

Women who have a negative TRAb and do not require ATD have a very low risk of fetal
or neonatal thyroid dysfunction
Gestational hyperemesis and hyperthyroidism
Thyroid function tests (TSH, total T4, or free T4 index, or free T4) and TRAb should be
measured in patients with hyperemesis gravidarum (5% weight loss, dehydration, and
ketonuria) and clinical features of hyperemesis

Aims and Objectives of the Study

To study fetal outcome in pregnant women with thyroid disorder

Fetal outcome with respect to

Miscarriage

Thyroid disorder in baby

Low birth weight

Intrauterine growth retardation

Intra uterine fetal death

NICU admission

A).Design : Observational study

B) Place of the study: LokmanyaTilak Municipal Medical College; Dept of Obstetrics &
Gynaecology
C) Proposed Duration of the Study: 1 and yr
D) Sample size: 50
E) Sampling Method:). This study was conducted from June 2011 to March 2012. Informed
consent was obtained from each patient included in the study
In the first visit, individuals at high risk for thyroid illness according to their medical history,
physical examination, or prior biochemical information had been considered and the women were
excluded if they had known chronic diseases such as thyroid diseases, usage of thyroid drugs, diabetes
mellitus, and hypertension. Data about maternal age, parity, obstetric history, gestational age (determined
18

by last menstrual period), medical history of thyroid drug usage, and physical examination of the mother
were collected twice: in the second trimester of pregnancy and at delivery. Physical examination of the
neonate was done in delivery room to determine Apgar score, resuscitation at birth, weight, Head
circumference, and length in the hospital.

Recommendations for Testing for Thyroid Disease During Pregnancy

The new recommendations for TSH levels during pregnancy are the following:

First trimester: less than 2.5 with a range of 0.1-2.5

Second trimester: 0.2-3.0

Third trimester: 0.3-3.0.

If the TSH is greater than 2.5 at any time during pregnancy, T4 levels should be checked to
determine whether the hypothyroidism is overt or subclinical.
If T4 is low, the diagnosis is overt hypothyroidism, which can impair the infant's neurocognitive
development. There are also increased risks for premature birth, low birthweight, and
miscarriage. Overt hypothyroidism must be treated.
If TSH is high and the T4 is normal, the diagnosis is subclinical hypothyroidism. In this case, the
next step is to check for antithyroid peroxidase antibodies. Women who are antibody positive
should be treated. The effect of subclinical hypothyroidism on fetal neurocognitive development
is not clear. But one large study showed lower IQ tests in the children of untreated women.
Treatment is necessary when TSH is 10 or more, regardless of the T4 level. In addition, TSH
should be monitored every 4 weeks during the first 20 weeks of gestation, then once again
between 26 and 32 weeks
we categorized pregnant women into five groups:

Category 1 (clinical hypothyroidism) was defined as an elevated TSH (> 3 mIU/L) in conjunction
with a low FT4. In Women with TSH 10 mIU/L, irrespective of their FT4 level, were also
considered as clinical hypothyroidism.

Category 2 (subclinical hypothyroidism) was defined if serum TSH was between 3 to 10 mIU/L
with a normal FT4 concentration.

Category 3 (Normal), was those with TSH of 0.2 to 3 mIU/L and FT4 of 11.84 3.86 to.

Category 4 (Subclinical hyperthyroidism) was defined as suppressed TSH (range, 0.1-0.2 mIU/L)
with normal FT4.

Category 5 (Overt hyperthyroidism) was defined as any suppressed TSH (< 0.2 mIU/L) when
accompanied by high FT4 and anyone with TSH < 0.1 mIU/L irrespective of FT4 level. In addition, we
calculated the prevalence of isolated hypothyroxinemia according to ATA guideline in which TSH was in
normal range but had low FT4.

F) INCLUSION CRITERIA

19

All pregnant female with thyroid disorder

G) EXCLUSION CRITERIA

H/O Cardiac disease.

H/O Bronchial asthma.

H/O Hematological disorder

Diabetic

Liver disorders
Maternal heart rate <60 or >120 beats per minute..

Parameters to be Studied ,
At the initiation of the Study

Age

Weight

Height

Gravida

Parity

Gestational period

Pregnancy history-number of children

History regarding tolerance to heat ,dryness of skin, weight gain, constipation

General physical examination-

Vital signs

Pulse

Bp

Cvs

Rs

Fetal heart rate

Hb

CBC
20

Platelet count,

Clinical examination

Routine investigation

Usg findings

Parameters: APGAR SCORE in baby at 1min ,5min

,fetal weight
serum TSH(72hrs from heel blood)

21

Duration
Frequency of Follow up
Parameters to be observed
Clinical examination
Routine examination
Detailed previous obstetric history
USG findings
Organization of Work elements
Name of the Milestone

Starting
Date

Expected Date of Completion ( Proposed

)

Primary end point

Secondary end point
Etcetetra

Work already done in the Field ( If any ) :

Bibliography

Staff to be appointed on Contractual basis ( if applicable ) : N.A

Number of Staff

Designation of Staff with duration of appointment

Remuneration to Staff # for complete project '

Work expected / Job Description of appointed Staff as per category

Comments by Biostatistician : N.A

Sample size calculation : N.A

Proposed Expenditure: N.A

22

H) References: ATTACHED
1Abalovich, M, et al. "Management of thyroid dysfunction during pregnancy and
postpartum: An Endocrine society clinical practice guideline." J Clin Endocrinol
Metab 92, no. 8 (2007): S1-S47. 2Abalovich, M, et al. "The relationship of
preconception thyrotropin levels to requirements for increasing the levothyroxine
dose during pregnancy in women with primary hypothyroidism." Thyroid 20, no. 10
(2010): 1175-1178. Abalovich, M, S Gutierrez, G Alcarez, G Maccallini, A Garcia,
and O 3Levalle. "Overt and subclinical hypothyroidism complicating pregnancy."
Thyroid 12 (2002): 63-68. Alvarez-3Pedrerol, M, et al. "Iodine levels and thyroid
hormones in healthy pregnant women and birth weight of their offspring." Eur J
Endocrinol 160 (2009): 423-429.

I) Names and Signatures of all the Investigators :

Principal Investigator
Dr.DEEPIKA SHARMA
Resident, OBGY
Dept. of OBGY LTMMC & LTMGH

Co Investigator
Dr.ARUN.H.NAYAK
PROFESSOR & HOU
Dept. of OBGY LTMMC
&LTMGH

Remarks and Signature of Head Concerned Department :

Dr.Y.S.NANDANWAR
Head of Dept

SINGATURE OF DEAN

23

Dept. of OBGY
TO STUDY PERINATAL OUTCOME IN THYROID DISORDER IN PREGNANCY
LTMMC & LTMGH

Patient information sheet

This is a TO STUDY PERINATAL OUTCOME IN THYROID DISORDER IN PREGNANCY
Maternal thyroid function changes during pregnancy and inadequate adaptation to these changes results in
thyroid dysfunction. The main pregnancy complications of hypothyroidism were anemia, preeclampsia,
prematurity, low-birth weight (LBW), fetal distress in labor, fetal death, and congenital hypothyroidism,
and neurocognitive deficits in children. Subclinical hypothyroidism might be associated with preterm
delivery and low Apgar score. Overt hyperthyroidism and subclinical hyperthyroidism affects about 0.2%
to 0.8% and 0.4% to 1% of pregnancies, respectively. Maternal hyperthyroidism may cause preterm
delivery, intrauterine growth restriction (IUGR), and neonatal thyrotoxicosis

I will be doing a observational study over a period of 2 yrs on pregnant women of gestational age
of 20 weeks to full term gestation. In this study I will be examining the patient and detailed
history will be noted, serum TSH of the patients high risk for thyroid illness. Patient will be called
for further follow up with repeat thyroid profile. This follow up visits will not involve any form
of invasive procedure or exorbitant expenditure intrapartum course will be noted. After delivery
patient will have to follow up couple of times with newborn till 28 days.
The data will be confidential & your identity will not be disclosed at any correspondence related
to this study.
I will be thankful for your kind cooperation.
For any further clarification you can contact us at any stage of study.

24

Dr. Deepika Sharma

Dr. Arun. H. Nayak

PG Student

PROF & HEAD OF UNIT

Ph:7506587897

Ph:9821331251

TO STUDY PERINATAL OUTCOME IN THYROID DISORDER IN PREGNANCY

CONSENT FORM

I____________________________________________ and my relative _________________

By name ____________________________ by relation have been explained in the language I
best understand the need for the study.
TO STUDY PERINATAL OUTCOME IN THYROID DISORDER IN PREGNANCY
To be conducted in LTMGH DURING 2014-2017. The materials and methods to be used by the
investigator and the confidentiality to be maintained during this study have been explained to us
by the investigator. I/we have also been explained the positive and negative variables studies.
I/we state that, I/we are willing to participate in the study on our own free will and not under
influence of anybody. I/we assume that , I shall not hold the hospital/doctors/staff responsible for
any untoward consequences arising out of the study.

Doctors sign

Patients sign

Relative's sign
25

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DISORDER IN PREGNANCY
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TO STUDY PERINATAL OUTCOME IN THYROID DISORDER IN PREGNANCY

CASE RECORD FORM

PROFORMA
Name:
Reg.No:
Age:
Education:
Socio-economic group:
Duration of pregnancy (weeks):
Chief complaints:

Menstrual history:
Obstetric history:
Parity
History of abortions
Family history:

27

Personal history:
COMPLAIN
Weight gain
Heat tolerance
Dryness /sweating
constipation

YES

NO

Dietary History
Clinical examination:

GENERAL EXAMINATION
Built and nourishment
Height
Weight
BMI

VITAL DATA
Temperature
Pulse rate
Blood pressure
Respiratory rate

SYSTEMIC EXAMINATION
Respiratory system
28

Cardiovascular system
CNS

OBSTETRIC EXAMINATION
Per Abdomen:
1
Per vaginal examination:

INVESTIGATIONS:
Hb %, CBC
Plateletes
Serum TSH

ULTRASONOGRAPHY:
Weeks of gestation
AFI
Estimated Fetal weight
Congenital anomalies(if any)

29

INTRAPARTUM
Duration of Labour
Mode of delivery:
Maternal outcome:
Fetal outcome:
Birth weight
APGAR

Hours

Minutes

NICU admission
Indication
Course in NICU

POSTPARTUM

Yes/ No

PNC Follow up

Contraceptive used If yes, Choice of Contraceptive

30

REFERENCES:
1. Stagnaro-Green A, Abalovich M, Alexander E, Azizi F, Mestman J, Negro R, et al. Guidelines of the
American Thyroid Association for the diagnosis and management of thyroid disease during pregnancy
and postpartum. Thyroid. 2011;21(10):1081125. doi: 10.1089/thy.2011.0087. [PMC free
article] [PubMed] [Cross Ref]
2. De Groot L, Abalovich M, Alexander EK, Amino N, Barbour L, Cobin RH, et al. Management of
thyroid dysfunction during pregnancy and postpartum: an Endocrine Society clinical practice guideline. J
Clin Endocrinol Metab. 2012;97(8):254365. doi: 10.1210/jc.2011-2803. [PubMed] [Cross Ref]
3. Donnay S, Arena J, Lucas A, Velasco I, Ares S, Working Group on Disorders Related to Iodine D, et al.
Iodine supplementation during pregnancy and lactation. Position statement of the working group on
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Dissertation Application Form

To
The Chairperson/secretory,
Institutional Ethics Committee-Human research
L.T.M.M.C. & GENERAL HOSPITAL
Subject: Submission of Dissertation /Thesis for Institutional Ethics Committee Review For M.S. in
The subject of OBSTETRICS AND GYNECOLOGY
Respected Sir,
I, am Dr. DEEPIKA SHARMA, registered for MS Obstetrics and Gynaecology in the year 2014
Under guidance of
Name of Guide: Dr.ARUN.H.NAYAK
Designation: PROFESSOR& HEAD OF UNIT
Department: OBSTETRICS & GYNAECOLOGY
L.T.M.M.C. &L.T.M.G.Hospital
I am due to appear for MS Obstetrics and Gynaecology in May-2017.
I am submitting herewith following documents of the project for review to Institutional Ethics
Committee Human Research. The study shall be conducted at LTMMC & LTMGH.
1. Dissertation Application
2. Protocol of the Research Project
3. Case Record Form
4. Patient Information Sheet and Informed Consent Form in English, Hindi and Marathi
5. Letter from the Departmental Dissertation Review Committee regarding satisfactory
scientific scrutiny duly signed by Guide and Head of Department.
I shall make a brief presentation for 3 minutes in front of Institutional Ethics Committee.

Signature of Postgraduate Student

The Chairperson/Secretary,
Institutional Ethics Committee- Human Research,
L.T.M.Medical College & L.T.M. General Hospital
Sub: Submission of Dissertation/Thesis for Institutional Ethics Committee Review.
MS
Course

Signature of Guide
Dr.Arun.H.Nayak
Dr. Y.S. NANDANWAR
(PROFESSOR & HEAD OF UNIT)
HEAD OF DEPARTMENT)

Obstetrics and Gynaecology

Branch

Signature of HOD

(PROFESSOR &

32

REPORT OF DEPARTMENTAL DISSERTATION COMMITTEE

DEPARTMENT
NAME OF STUDENT
NAME OF TEACHER
CANDIDATE ADMITTED IN THE YEAR
COLLEGE NAME AND ADDRESS

OBSTETRICS AND GYNAECOLOGY

DR.DEEPIKA SHARMA
DR.ARUN.H.NAYAK
2014
LOKMANYA TILAK MUNICIPAL
MEDICAL COLLEGE, SION, MUMBAI400022

To
The Chairperson
Institutional Ethics Committee,
LTMMC
Sub: Report of Departmental Dissertation Committee regarding Dissertation
Sir,
DR DEEPIKA SHARMA is admitted as a post graduate student for MS-OBGY in MUHS
Nashik in June 2014 .His project for dissertation titled TO STUDY PERINATAL OUTCOME IN
THYROID DISORDER IN PREGNANC under the guidance of DR ARUN.H.NAYAK has been
scrutinized by the departmental review board on 21/11/13and has been reviewed scientifically
and is recommended to Institutional Ethics Committee for approval

DR. Y.S. NANDANWAR

Professor & Head of
Department of obstetrics & gynaecology
LTMMC &LTMGH, Sion

SINGATURE OF CHAIRPERSON
DEPARTMENTAL REVIEW COMMITTEE

33

NAME OF COLLEGE

LOKMANYA TILAK MEDICAL

COLLEGE

DEPARTMENT

OBSTRETICS & GYNAECOLOGY

NAME OF THE GUIDE &

DR.ARUN.H.NAYAK ,LTMGH SION

COLLEGE NAME
CONTACT NO. OF GUIDE
THROUGH PROPER CHANNEL ONLY

TO ,
The Registrar
MUHS
Nashik 422004.
Subject : Submission of title Synopsis.
Respected Madam/Sir,
I Dr. Deepika Sharma registered for OBGY in june 2014 batch under guidance of
Dr Arun.H.Nayak (Head of Unit).
I am due to appear for MS OBGY
I am submitting my title of synopsis as mentioned below as suggested by aforesaid
guide

Title of Synopsis: TO STUDY PERINATAL OUTCOME IN THYROID

DISORDER IN PREGNANCY
Kindly accept and register my title of synopsis.
The Qualification of the teacher is recognized by the central council.
Dr .Deepika Sharma.
(Candidate Name & Signature)
Dr. Arun.H.Nayak.
(Guide Name & Signature)

Dr. Y.S.Nandanwar
(HOD Name & Signature with Dept seal)
34