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1 Noticias News Nouvelles The Centre for Mother, Infant, and Child Research 7 th Floor, 790 Bay Street Toronto ON CANADA M5G 1N8 Tel: Fax: tbs@sw.ca website: V O L U M E 8, I S S U E 3 M A R C H 3 1, We passed 1800 recruits!!! Great job! Overall Total: 1823 Total this month: 50 Recruitment Record! INSIDE THIS ISSUE Recruitment 1 Record A milestone has been reached: we have a new record of recruits in one month - Second Interim Analysis Changes to Emergency Help Line 1 2 Congratulations and great job!!! Keep up the excellent work!!! Query Tutorial 3 New Investigators Meeting South American Regional Meeting Feature of the Month Recruitment Excellence Second Interim Analysis The race to the 1800th recruit has come to an end and we are on our way to the next interim analysis! Congratulations and thank you to all of our collaborators for helping us get there! Recruitment Table 2yr Table 6 8 Congratulations to Dr Grzegorz Breborowicz and Dr Anna Dera and the team at University School of Medical Sciences in Poznan, Poland, for recruiting the 1800th patient! It is imperative that we receive all outstanding data and queries now so we can start our work on the second interim analysis!

2 PAGE 2 Changes to the Emergency Help Line The Emergency Help Line telephone number has changed to: (1) When you call this emergency number, you will now be able to speak to someone directly, or similar to our last Help Line, you can leave a voice message. A great new feature to the emergency Help Line is that you may also contact someone by sending an to: CMICRHELPLINE@sunnybrook.ca The Entry forms have been updated with the new instructions and will be sent to your centre with your regular top-up. Please remember: The Emergency Help Line should only be used when you are having difficulties that cannot wait until the next business day. All day-to-day inquiries should still be directed to the Data Coordinating Centre at TBS@sw.ca or (1) To randomise a patient, the calling details remain the same: 1. Complete the Entry form including page 3, questions Call the Randomisation Service at (1) Follow the instructions given on the phone to answer the questions (recorded on Entry form question 24-27) 4. Record the study group allocation in the Entry form, question 28

3 PAGE 3 Query Tutorial This month we will discuss the onset of labour on the Labour form, page 1 question 3. Mark ONE only If the patient was in spontaneous labour but did not progress to active labour and labour was augmented with oxytocin then onset of labour should only be marked spontaneous. It is incorrect to also mark oxytocin in this case.

4 PAGE 4 New Investigators Meeting In the next newsletter, please watch for highlights from the New Investigators Meeting which is being held on April 3, Stay tuned to find out about our first meeting of its kind. South American Regional Meeting We are excited to be hosting a TBS and CHIPS South American Regional Meeting on May 14-15, 2009 in Buenos Aires, Argentina. If we have not received your reply, please contact us to confirm your attendance for the meeting by fax or . We look forward to another successful meeting!

5 PAGE 5 Feature of the Month This month we would like to introduce Dr Tamas Major from Debrecen, Hungary. During a recent conversation with Dr Major, he has informed us that he is currently on a TBS data campaign. Although we have some difficulties from time to time, we make every effort to randomize as many patients as possible. Staff members give us a tremendous help, and friendly atmosphere at the first discussion with the patient makes it easier to recruit patients. ~ Dr Tamas Major Recruitment Excellence Congratulations to Dr Raul Abalos Gorostiaga and the team at Hospital Ramon Carrillo in Santiago del Estero, Argentina; Dr Danielly Scaranello Nunes Santana and the team at Hospital Universitario de Jundiai in Jundiai, Brazil; Dr Luis Leighton and the team at Hospital Dr Gustavo Fricke in Vina del Mar, Chile; Dr Marwan Hakim and the team at Nazareth Hospital (EMMS) in Nazareth, Israel; Dr Donnette Simms- Stewart and the team at University Hospital of the West Indies in Kingston, Jamaica; Prof Miroslava Gojnic and the team at University of Belgrade in Belgrade, Serbia. Keep up the excellent work! We will be sending a gold seal to place on your Certificate of Achievement.

6 Page 6 Twin Birth Study Recruitment (Projected sample size of 2800) as of March 31, 2009 Jan - Jan - Jan - Jan - Jan - Jul - Annual Dec Dec Dec Dec Dec Jun Dec Jan Feb Mar Grand Goal Total COUNTRY ARGENTINA BRAZIL CANADA POLAND ISRAEL EGYPT AUSTRALIA CHILE UK THE NETHERLANDS ESTONIA JAMAICA USA SPAIN JORDAN SERBIA HUNGARY ROMANIA BELGIUM GERMANY CROATIA GREECE Total CENTRES BY COUNTRY (Shaded area is prior to start-up) ARGENTINA Hospital LC Lagomaggiore, Mendoza Hospital Posadas, Buenos Aires Hospital Ramon Carrillo, Santiago del Estero Hospital Avellaneda, Tucuman Hospital JR Vidal, Corrientes Hospital Penna, Bahia Blanca Hospital Sarda, Buenos Aires Hospital Angela Iglesia de Llano, Corrientes Hospital Juan A Fernandez, Buenos Aires Hospital Alvarez, Buenos Aires Centres that are no longer recruiting 0 10 BRAZIL University of Campinas, Campinas Maternidade Escola da UFRJ, Rio de Janeiro University of Pernambuco, Recife Hospital Universitario Antonio Pedro, Niteroi Laranjeiras Clinica Perinatal, Rio de Janeiro ISCMPA-Maternidade Mario Totta, Porto Alegre Hospital Universitario de Jundiai, Jundiai UFPE, Recife Hospital Sao Lucas, Porto Alegre Botucatu Medical School, Botucatu Hospital Materno Infantil, Goiania CANADA Sunnybrook Health Sciences Centre, Toronto McMaster University Medical Centre, Hamilton IWK Health Centre, Halifax Regina General Hospital, Regina Trillium Health Centre, Mississauga Mount Sinai Hospital, Toronto Lions Gate Hospital, Vancouver Foothills Medical Centre, Calgary SMBD Jewish General Hospital, Montreal Royal Columbian Hospital, New Westminster Royal University Hospital, Saskatoon Eastern Health, St John's Toronto East General, Toronto North Bay General Hospital, North Bay St Joseph's Health Care, London Centres that are no longer recruiting 0 1 POLAND University School of Medical Sciences, Poznan Polish Mothers Memorial Hospital, Lodz Medical University of Gdansk, Gdansk

7 Page 7 Jan - Jan - Jan - Jan - Jan - Jul - Annual Dec Dec Dec Dec Dec Jun Dec Jan Feb Mar Grand Goal Total ISRAEL Edith Wolfson Medical Center, Holon Ma'ayney HaYeshua Medical Center, Bnei Brak Nazareth Hospital (EMMS), Nazareth HaEmek Medical Center, Afula Bnai Zion Medical Center, Haifa Poriya Government Hospital, Tiberias Hillel Yaffe Medical Center, Hadera EGYPT Assiut University Hospital, Assiut AUSTRALIA Ipswich Hospital, Ipswich St George Hospital, Sydney Mater Mothers' Hospital, Brisbane Toowoomba Base Hospital, Toowoomba Monash Medical Centre, Clayton Logan Hospital, Meadowbrook Townsville Hospital, Townsville Women's and Children's Hospital, Adelaide CHILE Hospital Dr Gustavo Fricke, Vina del Mar Hospital Dr Sotero del Rio, Puente Alto UK Nottingham City Hospital, Nottingham Bradford Royal Infirmary, Bradford Basildon & Thurrock University, Basildon Queen Elizabeth Hospital, King's Lynn University Hospital of North Staffordshire, Stoke-on-Trent Derriford Hospital, Plymouth Queens Medical Centre, Nottingham Lewisham Hospital, London THE NETHERLANDS Atrium Medical Center, Heerlen Academisch Ziekenhuis Maastricht, Maastricht Sint Lucas Andreas Ziekenhuis, Amsterdam Centres that are no longer recruiting 0 7 ESTONIA Tartu University Hospital - Women's Clinic, Tartu JAMAICA University Hospital of the West Indies, Kingston USA East Bay Perinatal Medical Associates, Oakland Maricopa Medical Center, Phoenix University of South Carolina, Columbia University of Iowa Hospitals and Clinics, Iowa City University of Miami, Miami Centres that are no longer recruiting 0 4 SPAIN Hospital Clinic-University of Barcelona, Barcelona JORDAN Islamic Hospital, Amman SERBIA University of Belgrade, Belgrade HUNGARY University of Debrecen, Debrecen ROMANIA University of Pharmacy and Medicine, Cluj-Napoca BELGIUM Vrije Universiteit Brussel, Brussels GERMANY Ludwig Maximilians University of Munich, Munich CUB - Virchow Klinikum, Berlin CUB - Benjamin Franklin, Berlin CROATIA Sveti Duh Hospital, Zagreb GREECE Alexandra Maternity, Athens Centres awaiting first patient: [COUNTRY: Hospital, City (annual goal)] [month/year start-up package sent] AUSTRALIA: Royal North Shore, St Leonards (3) [11/06]; CANADA: Children's & Women's Health Centre of BC, Vancouver (11) [02/08], St Paul s Hospital, Vancouver (3) [01/09]; THE NETHERLANDS: Maxima Medical Centre, Veldhoven (3) [06/08]; UK: Aberdeen Maternity, Aberdeen (6) [11/06], Liverpool Women's Hospital, Liverpool (12) [05/07]; USA: Washington University, St Louis (5) [01/07];

8 Page 8 2 Year Follow-up of TBS Babies The status of the TBS 2 Year Follow-up is displayed in the following table for centres that recruited patients. Centres are listed according to the total number of recruits by country and centre. See below for the number of follow-up assessments performed by your centre! Let's aim for 100% follow-up!! Status Totals As of March 2009 COUNTRY ARGENTINA BRAZIL CANADA POLAND ISRAEL EGYPT AUSTRALIA CHILE UK THE NETHERLANDS ESTONIA JAMAICA USA JORDAN SPAIN SERBIA HUNGARY ROMANIA BELGIUM GERMANY CROATIA GREECE Total % 88.5% 81.7% 68.1% 8.3% 40% CENTRES BY COUNTRY (Shaded area is prior to start-up) ARGENTINA Hospital LC Lagomaggiore, Mendoza Hospital Posadas, Buenos Aires Hospital Ramon Carrillo, Santiago del Estero Hospital Avellaneda, Tucuman Hospital JR Vidal, Corrientes Hospital Penna, Bahia Blanca Hospital Sarda, Buenos Aires Hospital Angela Iglesia de Llano, Corrientes Hospital Juan A Fernandez, Buenos Aires Hospital Ramos Mejia, Buenos Aires Hospital Alvarez, Buenos Aires 1 1 BRAZIL University of Campinas, Campinas Maternidade Escola da UFRJ, Rio de Janeiro University of Pernambuco, Recife Hospital Universitario Antonio Pedro, Niteroi Laranjeiras Clinica Perinatal, Rio de Janeiro ISCMPA-Maternidade Mario Totta, Porto Alegre Hospital Universitario de Jundiai, Jundiai 7 7 UFPE, Recife Hospital Sao Lucas, Porto Alegre Botucatu Medical School, Botucatu Hospital Materno Infantil, Goiania CANADA Sunnybrook Health Sciences Centre, Toronto McMaster University Medical Centre, Hamilton IWK Health Centre, Halifax Regina General Hospital, Regina Trillium Health Centre, Mississauga Mount Sinai Hospital, Toronto Lions Gate Hospital, Vancouver Foothills Medical Centre, Calgary SMBD Jewish General Hospital, Montreal Royal University Hospital, Saskatoon Royal Columbian Hospital, New Westminster Eastern Health, St John's Toronto East General, Toronto North Bay General Hospital, North Bay 2 2 St Joseph's Health Care, London York Central Hospital, Richmond Hill 1 1 POLAND Univ School of Medicine, Poznan Polish Mothers Memorial Hospital, Lodz Medical University of Gdansk, Gdansk

9 Page 9 Status Totals As of March 2009 ISRAEL Edith Wolfson Medical Center, Holon Ma'ayney HaYeshua Medical Center, Bnei Brak Nazareth Hospital (EMMS), Nazareth HaEmek Medical Center, Afula Bnai Zion Medical Center, Haifa Poriya Government Hospital, Tiberias Hillel Yaffe Medical Center, Hadera EGYPT Assiut University Hospital, Assiut AUSTRALIA Ipswich Hospital, Ipswich Mater Mothers' Hospital, Brisbane St George Hospital, Sydney Toowoomba Base Hospital, Toowoomba Monash Medical Centre, Clayton Logan Hospital, Meadowbrook Townsville Hospital, Townsville Women's and Children's Hospital, Adelaide 1 1 CHILE Hospital Dr Gustavo Fricke, Vina del Mar Hospital Dr Sotero del Rio, Puente Alto UK Nottingham City Hospital, Nottingham Bradford Royal Infirmary, Bradford Basildon & Thurrock University, Basildon Queen Elizabeth Hospital, King's Lynn University Hospital of North Staffordshire, Stoke-on-Trent Derriford Hospital, Plymouth Queens Medical Centre, Nottingham 3 3 Lewisham Hospital, London 3 3 THE NETHERLANDS Atrium Medical Center, Heerlen Maaslandziekenhuis Sittard, Sittard Academisch Ziekenhuis Maastricht, Maastricht Sint Lucas Andreas Ziekenhuis, Amsterdam ESTONIA Tartu University Hospital - Women's Clinic, Tartu JAMAICA University Hospital of the West Indies, Kingston USA East Bay Perinatal Medical Associates, Oakland Maricopa Medical Center, Phoenix University of South Carolina, Columbia University of Iowa Hospitals and Clinics, Iowa City Jamaica Hospital Medical Center, Jamaica Texas Tech UHSC, Lubbock 2 2 University of Miami, Miami 1 1 JORDAN Islamic Hospital, Amman SPAIN Hospital Clinic-University of Barcelona, Barcelona SERBIA University of Belgrade, Belgrade HUNGARY University of Debrecen, Debrecen ROMANIA University of Pharmacy and Medicine, Cluj-Napoca BELGIUM Vrije Universiteit Brussel, Brussels GERMANY Ludwig Maximilians University of Munich, Munich CUB - Virchow Klinikum, Berlin 3 3 CUB - Benjamin Franklin, Berlin CROATIA Sveti Duh Hospital, Zagreb GREECE Alexandra Maternity, Athens 1 3 4

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