PSG IMS R IHEC Student Project Review Application Form

PSG Institute of Medical Sciences & Research, Coimbatore 641 004, India De artment of Clinical Research & !
ioethics
" lication for Re#ie$ of Pro%ect Pro osal b& the Institutional 'uman (thics Committee
)his #ersion is for the e*clusi#e use b& students doin+ ro%ects ,e*ce t radiothera & and de#ice studies..................................................................................................
/ote0 Read this APPLICATION FORMAT completely before you start filling it !o not lea"e any items blan# If any item is not applicable to your study$ %rite &Not Applicable' or &NA' against that item (e encourage you to use the soft copy of this format and submit the printout of a %ord)processed application
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!ac2+round Information 3rite the title of &our ro osed research ro%ect in the bo* belo$0
" C4MP"R")I5( S)6D7 48 S"8()7 "/D (88IC"C7 48 I/)R"C(R5IC"9 849(7S C")'()(R 3I)' DI/4PR4S)4/( G(9 84R C(R5IC"9 RIP(/I/G "/D I/D6C)I4/ 48 9"!46R
:1
Sl1 /o1 * / 6 7 5 8 9
!rief rofile of those in#ol#ed in the ro%ect

/ame,s- of the Student,s& Guide,s- in 8699 $ith initials ,as it appears in their University MarksSheet/Institutional ID!R T + C,ITRA !R -,0+AN12(ARI 2 P Institutional ID /o1 of the Students & Guides 7ear of Stud& of Students and "cademic )itle;Desi+nation of the Guides M! !N-$!.O P.)M! O. /334)/3*/ "cademic <ualifications of the Guide,s-
34MM3/5
For office use only:
I'(C " lication /o1 21AL<
!ate of Receipt of application in the !CR- :Primary Re"ie%er;< !ate for%arded to I,1C< !ate for%arded by I,1C to Re"ie%ers< !ate of I,1C Panel Re"ie%$ if appliable< !ate of despatch of appro"al letter by I,1C<
II1
8urther articulars about the ro osed ro%ect

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PSG Institute of Medical Sciences & Research, Coimbatore 641 004, India De artment of Clinical Research & !ioethics
" =1 lication for Re#ie$ of Pro%ect Pro osal b& the Institutional 'uman (thics Committee
Introduction ; !ac2+round ,definition of the roblem, $h& do &ou consider the chosen to ic as a health roblem ; im ortant> and conse?uences leadin+ to the rationale of the stud&1 Include latest official statistics$ %here"er applicable; Sometimes it is essential to inter#ene re+nanc& for safet& of mother,fetus or both1 Planned reinduction cer#ical ri enin+ & induction of labour is a art of modern obstetric ractice 4ne of the main factors that influence the successful induction of labour is the state of uterine cer#i* " cer#i* that is closed & firm,difficult to distend increases the chance of failed induction lon+er duration of labour & caesarean section )herefore it is necessar& to use o timum techni?ue for cer#ical ri enin+ and safe confinement 4ne of the common method includes use of PG(: Gel for cer#ical ri enin+1in this method there is chance of uterine h& erstimulation & fetal heart chan+es Mechanical ri enin+ de#ices a l& ressure on internal os of the cer#i*,o#erstretchin+ lo$er uterine se+ment & indirectl& increases local secretion of rosta+landins1 8ole&s catheter is a mechanical ri enin+ de#ice1it is eas& to insert,relati#el& lo$ cost &fe$ ad#erse effects " number of randomised controlled trials ha#e in#esti+ated the efficac& of 8ole&s catheter Ris2 of caesarean section is reduced $ith 8ole&s catheter in these studies than con#entional methods ,PG(: Gel,o*&tocin)his stud& aims to find out $hether 8ole&s catheter can safel&&effecti#el& re lace PG(:+el in induction of labour in our o ulation1 8oles catheters main ad#anta+es are, it is ine* ensi#e,eas& to insert , atient satisfaction & fe$ ad#erse effects
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41
Pro#ide a brief Re#ie$ of 9iterature ,Ro9- on the to ic of &our chosen stud& here0
The RoL should not e=ceed one page >uote references adhering to the Vancouver Style of referencing The RoL should address the follo%ing three ?uestions< :i; (hat is already #no%n on this topic@ :ii; (hat are the gaps in e=isting #no%ledge@ and :iii; ho% do you propose to fill these gaps in #no%ledge through your study$ if applicable Critically re"ie% international$ national and regional literature on this topic Include t%o most recent references Aou are encouraged to rely on$ among other sources$ online sources such as PubMed and IndMED as other%ise you are li#ely to miss literature from Belectronic onlyC Dournals %ith no print "ersion
8ole&s catheter induction is su erior to PG (: +el induction in #arious randomised controlled studies1
Stud& conducted b& C(1P(//(99@ ublished in !A4G ,549 116,ISS6( 11 concludes Bsin+le balloon catheter offers best combination of safet& & atient comfort than double balloon catheter & PG(: G(91 Stud& b& /IR4M"/(S'@ ublished in int % +&naecolo+& obstetrics :00= a ril, ubmed-Bsho$ed there is no difference in efficac& bet$een 8ole&s & PG(:G(9 but 8ole&s ri ens cer#i* in short time & therefore short time duration of induction to deli#er&1 "n article ublished in "mA 4!S)()RICS &G7/"(C494G7 %an 1CCCBsho$ed reinduction time& total induction time are shorter,+reater bisho score chan+e ,lo$ atient char+es in 8ole&s than PG(: G(9 induction
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" stud& conducted in D(M '4SPI)"9 Mumbai sho$ed e?ual efficac& , but 8ole&s is better alternati#e because of lo$ cost&absent side effects1
E1
Rationale ; Austification for the stud&0
)o find better & safer alternati#e for induction than PG(: G(9 )o a#oid side effects )o ha#e a cost effecti#e method for the benefit of the atient 8or better atient satisfaction )o a#oid com lications
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61
'& othesis0 849(7S !69! C")'()(R IS " !())(R &S"8(R "9)(R/")I5( 84R PR(I/DD6C)I4/ C(R5IC"9 RIP(/I/G
F1 G1
Research <uestion0
Is 8ole&s catheter safe&better alternati#e for reinduction cer#ical ri enin+>
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"
C1
lication for Re#ie$ of Pro%ect Pro osal b& the Institutional 'uman (thics Committee
4b%ecti#es of the stud&0
C11 !road 4b%ecti#e,s-0)4 C4MP"R( S"8()7 & (88IC"C7 48 849(7S C")'()(R 3I)' PG(: G(9
C1: S ecific 4b%ecti#es
E/* COMPAR1 1FFICACA OF -OT, M1T,O!2
E// TO COMPAR1 2PONTAN1O02 !1LI+1RA RAT1 TO CA12AR1AN RAT1 (IT, FOL1A2 FP.1/.1L
E/6 TO COMPAR1 !0RATION INT1R+AL FROM IN!0CTION TO !1LI+1RA TO COMPAR1 N1ONATAL O0TCOM1 E/7
)4 C4MP"R( SID( (88(C)S )4 C4MP"R( P")I(/) S")IS8"C)I4/ 101 Methodolo+& of the stud&0 R"/D4MIS(D C4/)R499(D )RI"9 *3 * Type of !ata :Primary G 2econdary;<Primary *3 / 2tudy Population<Term pregnant %omen
*3 6 2tudy Locale :geographic area;<P2. ,O2PITAL$O. !1PARTM1NT *3 7 2tudy !esign :you are encouraged to attach a Flow-Diagram;< Randomised controlled trial selecting patients randomly %ho come for safe confinement and needs to be induced into t%o groups one group comprising 53 term patients for induction %ith P. 1/ gel and another 53 patients for Foleys bulb catheter induction Page 6 of 11
*3 5 2ample 2iHe<*33 *3 8 2ampling Method <Term pregnant %omen in need of induction selected randomly into t%o groups F 53 In FOL1A2 group F53 in P.1/ .1L .RO0P *3 9 !uration of the study :in months;< */ months *3 E Proposed dates of commencement of the study<May /3*3 *3 4 Proposed dates of conclusion of the study<May /3**
111 'o$ the stud& $ill be carried out> :e=plain the steps e g $ pre)inter"ention sur"ey$ health education Inumber and duration of each sessionJ$ post)inter"ention sur"ey$ etc ;
1011 101: 101= 1014
Ste 10 atients selected for induction Ste :0E0 Patients induced $ith 8ole&s catheter,E0 $ith PG(: G(9 Ste =0outcome of both induction methods obtained Ste 40outcome of both methods anal&sed
1:1 (#aluation Plan0 :describe as to ho% the obDecti"es of the study %ill be measured G %hat %ill be considered as success or other%ise$ of the study; 46)C4M( M("S6R(S 11C'"/G( I/ !IS'4P SC4R( :1M4D( 48 D(9I5(R7 =1C"(S"R("/ R")( 41I/D6C)I4/ )4 D(9I5(R7 I/)(R5"9 E1/((D 84R "6GM(/)")I4/ 616)(RI/( '7P(RS)IM69")I4/ F1P")I(/) S")IS8"C)I4/,I/ P"I/G1P(RI/")"9 46)C4M(
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1=1 Information Dissemination0 :tic# all that are applicable; *6 * *6 / *6 6 *6 7 *6 5 K Conferences :specify; K Publication in Dournal :gi"e details; K Clinical Meeting at P2. ,ospitals K CRRI Re"ie% Meeting in the !epartment K Other :specify; / No / No
141 Does the stud& in#ol#e collection of data from secondar& sources> * Aes 1E1 Does the stud& in#ol#e collection of biolo+ical sam les> 161 If &ou are collectin+ biolo+ical sam les, tic2 all that are a licable0 )& e of biolo+ical sam le ,e1+1, blood<uantit& of sam le ,$rite in unit e1+1, mlPur ose ,e1+1, estimation of 'b8rom all stud& #olunteers 4R from a sub@ sam le> * Aes
Sl1 /o1 1 : = 4
3rite number of sam les here
1F1 "re &ou informin+ the stud& artici ants that the biolo+ical sam les collected $ill be used for the stated ur ose onl&> * Aes / No 6 Not Applicable 1G1 3hat are the ris2s to human stud& #olunteers, if an&, that &ou antici ate in this stud&> 1C1 3hat are the benefits from this stud&, if an&, to the stud& #olunteers> :01 3ho $ill fund &our ro%ect e* enses> ,(nclose rele#ant documents* 2elf)funded / P2. IM2FR 6 P2., 7 Others :specify; LLLLLLLLLL
:11 Conflict of Interest, if an&0
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::1 References ,to be formatted b& adherin+ to the ancouver Style of referencin+-
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:=1 "ttach a co & each of the follo$in+ $ith this a lication0 ,items ::11 & ::1: are mandator&, $hile ::1= is o tional/6 * /6 / /6 6 /6 7 ProDect TimelineG .antt Chart sho%ing %ee#)%ise acti"ities for the %hole study period Template of HInformed ConsentI in the prescribed format M in 1nglish :and in TAMIL$ if applicable; !ocument sho%ing financial support$ if any Flo%)!iagram describing the study design :this is optional$ but you are strongly encouraged to dra% one and enclose it %ith this application; :Refer item No C14 on Page 5 of this format;
D(C9"R")I4/
IG(e hereby declare that IG(e ha"e completed all sections of this application and attached all the re?uired documents IG(e further declare that all the information pro"ided in this application and its attachments are true to the best of myGour #no%ledge and belief IG(e understand that the appro"al to this study %ill be cancelled if IG%e ha"e pro"ided any %rong information or %ithheld rele"ant information from this proforma IG(e assure that myGour proDect entitled :%rite the title of your proDect;LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL$ if appro"ed by the Institutional ,uman 1thics Committee of P2. IM2FR %ill be carried out by adhering to the plan described in this application$ and that de"iation from the same %ithout informing the I,1C shall result in cancellation of the appro"al IG(e understand that I amG%e are liable to inform the I,1C about any change made in the methodology of the study /ame,s- and Si+nature,s- of the Students in#ol#ed in this ro%ect0 * / 6 7 Date0 /ame and Si+nature of the 8acult&@Guide of this Pro%ect0 ......................................... Page 10 of 11 Name< Name< Name< Name< 2ignature< 2ignature< 2ignature< 2ignature<
Si+nature and seal of the Professor & 'ead of the De artment throu+h $hich the ro%ect is ro osed to be im lemented0
J J
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PSG IMS R IHEC Student Project Review Application Form

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PSG IMS R IHEC Student Project Review Application Form

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PSG Institute of Medical Sciences & Research, Coimbatore 641 004, India De artment of Clinical Research & !

!rief rofile of those in#ol#ed in the ro%ect

For office use only:

I'(C " lication /o1 21AL<

8urther articulars about the ro osed ro%ect

Rationale ; Austification for the stud&0

Is 8ole&s catheter safe&better alternati#e for reinduction cer#ical ri enin+>

4b%ecti#es of the stud&0

C1: S ecific 4b%ecti#es

E/* COMPAR1 1FFICACA OF -OT, M1T,O!2

1011 101: 101= 1014

3rite number of sam les here

:11 Conflict of Interest, if an&0

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