ࡱ> ;>89:m bjbj 8bb@  8N Bz0XXXyyyyyyy$r{(~yX6"XXXyy"""XRy"Xy""}$$*^$yz0Bz$,~~$~$TXX"XXXXXyyzXXXBzXXXX~XXXXXXXXX B :   Trial Protocol Name C-Stich2Rec Ref14/ES/1004Chief InvestigatorProfessor Katie Morris SponsorBirmingham Womens and Childrens NHS Foundation TrustEudraCT NumberN/AISRCTN Number12981869HTA Grant reference 16/151/01CSP (IRAS ID) 101577 40203 Versions of documents DocumentVersionDateEthics approval dateProtocolCurrent protocol Version 6.021st February 202330th March 2023Superseded protocol Version 5.0 12th October 2021 17th January 2022Superseded Protocol Version 4.017th September 20201st October 2020Superseded protocolVersion 3.031st January 20203rd June 2020Superseded protocolVersion 2.013th November 201816th November 2018Superseded protocolVersion 1.0Not approved had to re-submitPatient Information Sheet (PIS)Current PIS main trial Version 5.0 5th January 2021 17th January 2022Superseded PI Version 4.0 Not approved Superseded PIS main trialVersion 3.017th September 202026th April 2021Superseded PIS Version 2.013th November 2018 16th November 2018 Superseded PISVersion 1.0Not approved had to re-submitCurrent PIS Observational cohort Version 3.0 5th January 2021 17th January 2022Superseded PIS Observational cohort Version 2.0 Not approved Superseded PIS Observational cohort Version 1.017th September 20201st October 2020Consent Form(s)Current Consent form Version 4.0 3rd November 2021 17th January 2022 Superseded Consent form Version 3.017th September 202026th April 2021Superseded Consent form main trial Version 2.013th November 2018 16th November 2018 Superseded Consent Form main trialVersion 1.0Not approved had to re-submitGP Letter Current GP letter Version 4.0 30th November 202117th January 2022Superseded GP letter Version 3.017th September 202026th April 2021Superseded GP letterVersion 2.012th November 201823rd June 2020Superseded GP letter Version 1.0Not approved had to re-submitCRFs Randomisation Note pad Version 5.010th May 2021 Observational Note pad Version 1.0 10th May 2021Participant contact details form Version 3.010th May 2021(Cerclage Placement Form) Treatment management form Version 3.010th May 2021Post consent Inpatient Management formVersion 4.03rd July 2023Cerclage Removal formVersion 4.010th May 2021 Microbiology FormVersion 4.010th May 2021Pregnancy Outcome formVersion 3.010th May 2021Maternal Outcome formVersion 4.010th May 2021Baby Outcome FormVersion 4.010th May 2021Hospital admission in pregnancyVersion 4.07th September 2021Serious Adverse EventVersion 2.010th May 2021Minimal Data setVersion 6.05th June 2023 Screening formVersion 3.010th May 2021PARCA-R questionnaire Version 1.05th October 20182 year follow up questionnaire Version 2.0 21st December 2021Poster Advertisement(s)Version 1.029th March 2019Current posterVersion 1.029th March 20193rd May 2019Prompt cardsVersion 1.029th March 2019 3rd May 2019Keyring reminder card ( small prompt cards ) Version 1.029th March 2019 3rd May 2019     C-Stich2 VERSION CONTROL DOCUMENT CHECKLIST C-Stich2 Version Control Document Checklist 1st August 2023 "#*+567<JS`abijúɪ{na{WPGWhThN%^J ho^JhhhN%5^Jhoh YCJ^JaJhohoCJ^JaJhh Y^J h]Q ^J hx^J h%<^Jhh Y5^Jh5\ h^wb7^Jh5\ h5\ ^J hS5^Jhh^wb^J ho^Jhh^wb5^Jh"8h"CJaJ3jh"8h3\5CJU^JaJmHnHsH uh3\CJaJ#+6 $Ifgdgd"867JbjYL?L2 $Ifgdo $Ifgd]Q $Ifgdkd$$Ifl\ d* ^ [ G t0644 laPyt2UYLLLL $Ifgdkd$$Iflw\ d* ^ [ G t0644 laPyt2U    ! 7 K M ƿ͗|sgXKAKhc~5B*phhhc~5B*phhF;h/ 5;>*CJaJhF;hoYi5CJaJh3\5CJaJhB5CJaJhhB^JhohB^Jh2UB*\^JphhUVhB^J hB^J hB5hUVhB5 hB^Jh h2U^JhhhB5^J hB\ hB5\hhN%^JhohN%^Jhoho\^JYK>0 $7$8$H$Ifgd2U $Ifgd $7$8$H$IfgdBkdf$$Ifl\ d* ^ [ G t0644 laPyt2U  ;kd$$Ifl\ d* ^ [ G t0644 laPyt2U $Ifgd$If^`gdB ! * 2 7 L $If]^gd $IfgdoYi$ !a$gdL M V ) $Ifgd|{kd$$Ifl8\Q'  t(0m(644 laPp(ytc~M U V Z k l w x z | ⽭n\I$hIJIhKH5B*OJQJ^Jph#hIJIh5B*H*OJQJph hIJIh15B*OJQJph hIJIh5B*OJQJph hIJIh65B*OJQJphhrah65OJQJh6h65H*OJQJ^Jh65OJQJ^Jh6h65H*OJQJhh65OJQJh65OJQJ hoYihc~hhc~5 hc~5V W X Y $Ifgd$If]^gdY Z l )$$Ifa$gdc~kd$$Ifl8\Q'  t(0m(644 laPp(ytc~l x *kd$$Ifl8\Q' t0m(644 laPytc~ $Ifgdc~ $Ifgdra$If]^gdc~ $Ifgdc~ $Ifgdra$If]^gdc~$$Ifa$gdc~         ) * + ŹtaMa:.hrahc~5OJQJ$hihc~5B*OJQJ^Jph'hih]v5B*H*OJQJ^Jph$hih]v5B*OJQJ^Jph#hih]v5B*H*OJQJph hih]v5B*OJQJph hihc~5B*OJQJph hih:B75B*OJQJphhrah5OJQJ$hIJIh5B*OJQJ^Jph$hIJIhKH5B*OJQJ^Jph'hIJIhKH5B*H*OJQJ^Jph   YI4' $Ifgdra$If]^gdc~$$Ifa$gdc~kd$$Ifl8\Q' t0m(644 laPytc~ * + ? 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