ࡱ>  Mbjbj## 4AA 2*2*,,,,,,82-T-,,-----IJIJIJ $P-,IJGIJIJIJ-2*2*--BOOOIJ^2*-,-yOIJOO$,/-0FJvJeX0͢bK\//, IJIJOIJIJIJIJIJ--yMzIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJ (:    Consent Form I understand that I require a cervical stitch as part of my standard pregnancy care. I confirm that I have read and understand the C-STICH Information Sheet Version . dated for the above study. I have had the opportunity to consider the information, and any questions I have asked have been answered to my satisfaction. I understand that the type of thread used in my stitch will be chosen at random between a single strand thread or a woven thread. I will not know which type of thread is used. I understand that my participation is voluntary, that I am free to withdraw at any time without giving a reason and my medical care or legal rights will not be affected. I understand that data collected up to my time of withdrawal may be used. I understand that my doctor will provide information about my progress, in confidence, to the central organisers at Birmingham Clinical Trials Unit (BCTU).  I agree to my GP being informed of my participation in the C-STICH Study. I agree that, where available, my doctor may take a vaginal swab and/or remove my cervical stitch, and use these samples to identify which (if any) bacteria are present. I understand that these samples will be destroyed afterwards, in accordance with local hospital protocol. I understand that my information and any samples taken will be used for medical research only and that I will not be identified in any way when the results are made public. I understand that relevant sections of my, and my babys, medical notes, ie., those held by my GP, or those held at the hospital where I deliver my baby, including data held by NHS Digital (England and Wales) or ISD Scotland, and other central UK NHS bodies may be used or looked at to provide information about mine and my babys health status. I give permission for individuals from the University 鶹ѡ Clinical Trials Unit, representatives of the sponsor, regulatory authorities or the NHS Trust to have direct access to my records. Data collected that identifies me by name, (consent form), will be transferred from where it is collected, and stored at the University 鶹ѡ Clinical Trials Unit. I agree to the transfer and storage of this data.  I understand what is involved in the C-STICH Study and agree to participate. _________________________ _______________ _______________________ Name of Patient Date Signature _________________________ _______________ ________________________ Name of Researcher Date Signature 4 Copies of C-STICH Consent Forms: 1 copy for patient, 1 copy for researcher, 1 copy to the patients hospital notes, and 1 copy to be sent to BCTU.  C-STICH Patient Trial Number: (Please complete when patient is randomised)     ISRCTN15373349; IRAS 164389 C-STICH consent form REC: Cambridgeshire and Hertfordshire Version 5.0 Dated 18 September 2017 Trust logo  Cerclage Suture Type for an Insufficient Cervix and its effect on Health outcomes (C-STICH) Please initial Chief Investigator (CI), Mr Philip Toozs-Hobson each box    *3?Eklno̰̾̈|qfq[qPqA6h0hR CJaJjh0hICJUaJh0h)CJaJh0hhv%CJaJh0hwVCJaJh0hb_CJaJhMk8hR 5CJ aJ &jhb_CJUaJmHnHtH u&jh)CJUaJmHnHtH ujhc8UmHnHujh)UmHnHuhUeCJaJjh)LUmHnHtH ujh59UmHnHujh)UmHnHu mne f      .$]a$gdn .$]a$gdCl $]a$gdn.$]a$gdngdR $^a$gdUe # ' 1 H Q c e f g ɾ߶߫ߠ߫ߕ~sh]Rh0hCJaJh0hB*CJaJh0hnCJaJh0hhv%CJaJ,jh0hICJUaJmHnHtH uh0h 'CJaJh0h3/CJaJh0hCJaJhA(CJaJh0h2CJaJh0h'j~CJaJh0huOCJaJh0hR CJaJh0hCJaJh0hb_CJaJ    H J Q p    ȽȲȲvk\E:h0hCOCJaJ,jh0hnCJUaJmHnHsH ujh0h*;CJUaJh0hACJaJhR CJ^JnH tH hqwh_0CJ^JnH tH hqwh_0CJ^Jh3IBhR CJ^Jh3IBh3/CJ^Jh0h3/CJaJh0hCJaJh0hR CJaJ,jh0hICJUaJmHnHsH uh0hb_CJaJh0h)CJaJ     m     ĹmbbWWHWbWbjh0hICJUaJh0h3/CJaJh0hCJaJ,jh0hICJUaJmHnHtH uh0hX-CJaJh0hClCJh0himCJaJh0hLCJaJh0hDCJaJh0hClCJaJ,jh0hX-CJUaJmHnHtH uh0hX-B*CJaJphh0hR CJaJh0hUeCJaJ  Z~~ $a$gdR  Tgdngdn Tgdn  Tgdn.$t]ta$gdqo$a$gdn.$t]ta$gd3/.$]a$gdn  *5<KL\^hrt34avxʿʿʿʿʴʞʩuh0hR CJaJh+;CJaJh0h2CJaJh0h_0CJaJh0hQCJaJh0h 'CJaJh0hD0CJaJh0h 1CJaJh0hCJaJh.PCJaJh CJaJh0h3/CJaJjh0hCJUaJ(!"QR^ef}~0Z޵өޕފti^RGhMk8hnCJaJhMk8hn>*CJaJhrhrCJaJh0hrCJaJh0hUeCJaJh0hCOCJaJh0hR CJaJ&jhACJUaJmHnHtH uh0h_06CJaJh0h+CJaJh+;CJaJhqwh_0CJaJhqwh+CJaJh0h_0CJaJ,jh0hACJUaJmHnHtH uZlm~>D]^~pg[OGCGCh}xjh}xUhnh5CJaJhMk8hR 5CJaJhn5CJaJ hCO5CJaJmHnHtH u hUe5CJaJmHnHtH u)jh25CJUaJmHnHtH uh`h`5CJaJh`hR 5CJaJh`hUe5CJaJhMk8hnCJaJhMk8hn>*CJaJhrhnCJaJhnCJaJhMk8hnCJaJ~klmnogd4 %<gd4$ %<a$gd4gdn $a$gdy $DFNRVWXZdgijklmnopq{|޶ީwsc_hUe *hZaThUeCJ OJQJaJ hy hA CCJOJQJh@CJOJQJh[CJOJQJh6CJOJQJhmBCJOJQJhB*h4CJOJQJhCJOJQJh4CJOJQJhACJOJQJhCJOJQJh4h4CJOJQJh;:h*h}xjh}xU%opq|} !*+,./12457gdR gdb_$a$gd)$a$gd5 $^a$gdUeY$a$gdc8|}~  !*,/ҾҾҾҾҾҾ|tkb|^U^Qhb_h)h)CJh)h25CJaJhg5CJaJhgCJaJh)h)CJaJh5h)h5CJhUehUehUeCJaJh5h#s0JXCJaJh2h7h7CJaJ&hB*h75CJOJQJ\^JaJ/hB*h75B*CJOJQJ\^JaJphhc8jhB*5CJ UaJ hy /25<>@ABDEHKLMhnh5CJaJh}xh;*hCJuhh3/hX-hb_hy  789:;<=>?@ABDEGHJKLMgdngd;*gdgd3/gdX-gdR &P +p,p-p.p/R 43536373:p '<0@P . 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