Deepika Thesis Final

Project Title

TO STUDY PERINATAL OUTCOME IN THYROID DISORDER IN PREGNANCY

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• Communications and Amendments Dispatch Noting Page ( 1 blank page with heading ) *

• IEC Agenda & Minutes of Meeting Noting Page ( 2 blank Pages with heading ) *

• Acknowledgement Form in given SRS format *

• Xerox copy of Research Project Application Fee Receipt *

• Title Page in given SRS format *

• Brief Curriculum vitae of Principal Investigator( maximum 2 pages) *

• Covering Letter in given SRS format *

• Joint Undertaking by Principal Investigator & Sponsor ( if applicable ) in given SRS format *

• Project Index Page in given SRS format *

I Project Format• Project Summary in given SRS format• Research Project Application Form in given

SRS format• References• Project specific Patient Information Sheet ( 3

languages )• Project Specific Informed Consent Form ( 3

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Questionnaire / Patient DiaryII Additional Documents ( as applicable ) see Index Page

format• Insurance Cover * ( compulsory for sponsored

Projects )III Project Closure Letter in given format *

• Entire Document submission ( except Documents submitted under “ Additional Documents”) on a CD – Word Format 2003 with Year, Project Title & PI Name written on the CD by a permanent marker pen.

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Communications and Amendments Dispatch Noting Page

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IEC Agenda & Minutes of Meeting Noting Page 1

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IEC Agenda & Minutes of Meeting Noting Page 2

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Acknowledgment Form

Project Title

TO STUDY PERINATAL OUTCOME IN THYROID DISORDER IN PREGNANACY

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ACKNOWLEDGEMENT( SRS ) Inward Dispatch No. IEC Inward No. Received in SRS Office on Date<YYYYMMDD> at Time<hh: mm>Stamp

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Title Page

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Project Type * THESISAbbreviated Project Title (maximum 25 characters)

THYROID DISORDER IN PREGNANCY

Project Title ( Full )TO STUDY PERINATAL OUTCOME IN THYROID DISORDER IN PREGNANCY

Principal Investigator Name DR.DEEPIKA SHARMACo – Investigator Name / Names

DR. ARUN. H . NAYAK

Sponsor Name * NA

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Brief Curriculum Vitae of Principal Investigator

• Name

First NameDr.DEEPIKA

Last NameSHARMA

• Present position with work address

PositionPost graduate StudentDept. of OBGY

Street address or postal addressRMO QTRS.LTMGHSION

Name of institution or organization:LokmanyaTilak Municipal Medical college & GeneralHospital

City & postal/zip code:Mumbai -400022

Start date (at least year): Country:India

• Main University Degree(s)

Name of university/institute:MAHARASHTRA UNIVERSITY OF HEALTH SCIENCES

Degree awarded:MBBS

City & country:MUMBAI,INDIA

Year of graduation:2014

• Professional Training- None

• Registration/Medical License number (where applicable) MP15552

• Previous Appointments

Position:STUDENT

Dates:

Institution/organization: City & country:

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LokmanyaTilak Municipal Medical college & GeneralHospital

MUMBAI, INDIA

Covering Letter

To,The Chairperson,Institutional Ethics Committee (Human Research),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 TITLE—TO 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

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Joint Undertaking by Principal Investigator and Sponsor

To, The Staff & Research SocietyLTMG 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.

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• Project Index Page

Project Index Page

Project Title


Index

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

Page Nos.

PI Chk

Check ( SRS use )

• 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• Investigator’s 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

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may be required ( Sample List enclosed below )• Project Completion Letter *

• * Mandatory

Project Summary

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 Retrospective

Single center 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 Yes No

Is marketed in other countries: Yes No

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Please Specify_________________

If not marketed in India, is DCG(I) permission attached . Yes No In Additional Documents Chapter On Page no ____

ii) Is the test drug an Investigational New Drug(IND)? Yes No If yes, is the Investigator’s Brochure which containsdata of pre-clinical studies attached. Yes No In Additional Documents Chapter On Page no ____

If IND, is attach DCG(I) permission. Yes No In Additional Documents Chapter On Page no ____

iii) Does the test drug involve a change in use, dosage,route of administration? Yes No If yes, is copy of DCG(I) permission attached In Additional Documents Chapter On Page no ____

3. Clinical Study is : NA Phase I Phase II Phase III Phase IV

4. Subject Selection :

i) Number of subjects at this centre 50

ii) If multicentric, Total number of subjects __NA_____

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

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iii) recombinant/gene therapy

If yes, is copy of GEAC permission permission attached In Additional Documents Chapter On Page no ____

Yes

Yes

No

No

iv) ionizing radiation/radioisotopes

If yes, is copy of BARC permission permission attached In Additional Documents Chapter On Page no ____

Yes

Yes

No

No

v) Infectious/biohazardous specimens Yes No

vi)Will pre-existing/stored/left over sample be used? Yes No

vii)Will samples be collected for banking/future research Yes No

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

If yes, is copy of DGFT approval /permission attached In Additional Documents Chapter On Page no ____

Yes

Yes

No

No

ix)Is there any collaboration with any foreign lab., clinic or hospital?

If yes, is copy of HMSC approval / permission attached In Additional Documents Chapter On Page no ____

Yes

Yes

No

No

6. Will any advertising be done for recruitment of Subjects? (Posters, flyers, brochures, etc.) If yes, is a copy for IEC(HR) review

In Additional Documents Chapter On Page no ____

Yes

Yes

No

No

7. Data Monitoring

i)Is there a separate data & safety monitoring board (DSMB)? Yes No

ii)Is there a plan for interim analysis of data? Yes No

iii)For how long will the trial data be preserved? _________years

8. Is there compensation for participation?

If yes, Monetary In kind

Specify amount/type:___________________________________

Yes No

9. Is there any arrangement for compensation for trial related injury? Yes No

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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 SHARMAPost GraduateDept. of Obst&GynL.T.M.M. College &L.T.M.G. Hospital,Sion, Mumbai 400 022

Research Protocol Application

• Abbreviated Project TITLE—THYROID DISORDER IN PREGNANCY

• Project Title


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• Principal Investigator Name

Dr.DEEPIKA SHARMAPost Graduate Dept. of Obstetrics & Gynaecology

• 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 PREGNANCYMaternal 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

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(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 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 30–40 d and then every 4–6 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 4–6 wk for elevation of TSH above the normal range for pregnancy

HYPERTHYROIDISM IN PREGNANCY

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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. 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

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B) Place of the study: LokmanyaTilak Municipal Medical College; Dept of Obstetrics & Gynaecology

C) Proposed Duration of the Study: 1 and ½ 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

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.

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• 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

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

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• 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

• Platelet count,

• Clinical examination

• Routine investigation

• Usg findings

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

•

,fetal weight

serum TSH(72hrs from heel blood)

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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 pointSecondary end pointEtcetetra

• 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

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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 Co InvestigatorDr.DEEPIKA SHARMA Dr.ARUN.H.NAYAKResident, OBGY PROFESSOR & HOUDept. of OBGY LTMMC & LTMGH Dept. of OBGY LTMMC &LTMGH

Remarks and Signature of Head Concerned Department :

Dr.Y.S.NANDANWAR SINGATURE OF DEAN Head of Dept Dept. of OBGY LTMMC & LTMGH

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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.

Dr. Deepika Sharma Dr. Arun. H. Nayak

PG Student PROF & HEAD OF UNIT

Ph:7506587897 Ph:9821331251

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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 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.

Doctor’s sign Patient’s sign Relative's sign

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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:

Personal history:

COMPLAIN YES NO

Weight gain

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Heat tolerance

Dryness /sweating

constipation

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

Cardiovascular system

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CNS

OBSTETRIC EXAMINATION

Per Abdomen:

Per vaginal examination:

INVESTIGATIONS:

Hb %, CBC

Plateletes

Serum TSH

ULTRASONOGRAPHY:

Weeks of gestation

AFI

Estimated Fetal weight

Congenital anomalies(if any)

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INTRAPARTUM

Duration of Labour Hours Minutes

Mode of delivery:

Maternal outcome:

Fetal outcome:

Birth weight

APGAR

NICU admission

Indication

Course in NICU

POSTPARTUM Yes/ No

PNC Follow up

Contraceptive used If yes, Choice of Contraceptive

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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):1081–125. 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):2543–65. 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 disorders related to iodine deficiency and thyroid dysfunction of the Spanish Society of Endocrinology and Nutrition. Endocrinol Nutr. 2014;61(1):27–34. doi: 10.1016/j.endonu.2013.05.004. [PubMed] [Cross Ref]

4. Taylor PN, Okosieme OE, Murphy R, Hales C, Chiusano E, Maina A, et al. Maternal perchlorate levels in women with borderline thyroid function during pregnancy and the cognitive development of their offspring: data from the controlled antenatal thyroid study. J Clin Endocrinol Metab. 2014;99(11):4291–8. doi: 10.1210/jc.2014-1901. [PubMed] [Cross Ref]

5. Webster GM, Venners SA, Mattman A, Martin JW. Associations between perfluoroalkyl acids (PFASs) and maternal thyroid hormones in early pregnancy: a population-based cohort study. Environ Res. 2014;133:338–47. doi: 10.1016/j.envres.2014.06.012. [PubMed][Cross Ref]

6. Amouzegar A, Ainy E, Khazan M, Mehran L, Hedayati M, Azizi F. Local versus international r

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Dissertation Application Form

ToThe Chairperson/secretory,Institutional Ethics Committee-Human researchL.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 2014Under guidance ofName of Guide: Dr.ARUN.H.NAYAKDesignation: PROFESSOR& HEAD OF UNITDepartment: OBSTETRICS & GYNAECOLOGY

L.T.M.M.C. &L.T.M.G.HospitalI 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 Application2. Protocol of the Research Project3. Case Record Form4. Patient Information Sheet and Informed Consent Form in English, Hindi and Marathi5. 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 StudentThe 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 Obstetrics and GynaecologyCourse Branch

Signature of Guide Signature of HODDr.Arun.H.Nayak Dr. Y.S. NANDANWAR

(PROFESSOR & HEAD OF UNIT) (PROFESSOR & HEAD OF DEPARTMENT)

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REPORT OF DEPARTMENTAL DISSERTATION COMMITTEE

DEPARTMENT OBSTETRICS AND GYNAECOLOGYNAME OF STUDENT DR.DEEPIKA SHARMANAME OF TEACHER DR.ARUN.H.NAYAKCANDIDATE ADMITTED IN THE YEAR 2014COLLEGE NAME AND ADDRESS LOKMANYA TILAK MUNICIPAL

MEDICAL COLLEGE, SION, MUMBAI-400022

ToThe ChairpersonInstitutional 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 SINGATURE OF CHAIRPERSON Professor & Head of DEPARTMENTAL REVIEW COMMITTEE Department of obstetrics & gynaecologyLTMMC &LTMGH, Sion

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NAME OF COLLEGE LOKMANYA TILAK MEDICAL COLLEGE

DEPARTMENT OBSTRETICS & GYNAECOLOGY

NAME OF THE GUIDE &

COLLEGE NAME

DR.ARUN.H.NAYAK ,LTMGH SION

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. Dr. Y.S.Nandanwar

(Guide Name & Signature) (HOD Name & Signature with Dept seal)

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Deepika Thesis Final

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