Image of the Month / Image du mois Congenital Atresia of the Fallopian Tube Atrésie congénitale de la trompe de Fallope...

Transcription

1 Journal of Obstetrics and Gynaecology Canada The official voice of reproductive health care in Canada Le porte-parole officiel des soins génésiques au Canada Journal d obstétrique et gynécologie du Canada Volume 30, Number 1 volume 30, numéro 1 January janvier 2008 Image of the Month / Image du mois Congenital Atresia of the Fallopian Tube Atrésie congénitale de la trompe de Fallope Vincent Y.T. Cheung Guest Editorial / Éditorial sollicité Prenatal Choices for Canadian Women: Individual Choice or the Public Good? Choix prénatals offerts aux Canadiennes : Liberté de choix ou bien public? R. Douglas Wilson Obstetrics Prenatal HIV Testing: Women s Experiences of Informed Consent in Toronto, Ontario Dale Guenter, Angela M. Barbara, Randi Zlotnik Shaul, Mark H. Yudin, Robert S. Remis, Susan M. King Factors Associated With a Successful External Cephalic Version in the Early ECV Trial Eileen K. Hutton, Carolyn A. Saunders, Maobing Tu, Kathrin Stoll, Jonathan Berkowitz, for the Early External Cephalic Version Trial Collaborators Group Validation of a Screening Tool to Identify the Nutritionally at-risk Pregnancy Marie-Paule Duquette, Hélène Payette, Jean-Marie Moutquin, Théa Demmers, Janine Desrosiers-Choquette Women s Health Access to Web-Based Personalized Antenatal Health Records for Pregnant Women: A Randomized Controlled Trial Elizabeth Shaw, Michelle Howard, David Chan, Heather Waters, Janusz Kaczorowski, David Price, Joyce Zazulak Health and Social Problems Encountered by Treated and Untreated Obstetric Fistula Patients in Rural Ethiopia Mulu Muleta, E. Catherine Hamlin, Mesganaw Fantahun, Ruth C. Kennedy, Biruk Tafesse Case Reports Spontaneous Bilateral Tubal Pregnancies: A Case Report James Andrews, Scott Farrell Recalcitrant Trichomonas Vaginalis Infections Successfully Treated With Vaginal Acidification Anjali Aggarwal, R. Michael Shier Education Obstetrics and Gynaecology Residents Self-Rated Knowledge, Motivation, Skill, and Practice Patterns in Counselling for Contraception, STI Prevention, Sexual Dysfunction, and Intimate Partner Violence and Sexual Coercion Meivys Garcia, William A. Fisher SOGC Technical Update / Mise à jour technique de la SOGC The Use of Progesterone for Prevention of Preterm Birth Utilisation de progestérone pour la prévention de l accouchement prématuré Dan Farine, William Robert Mundle, Jodie Dodd APOG Abstract Program The Association of Professors of Obstetrics and Gynaecology of Canada (APOG) Abstracts Instructions for Authors / Instructions à l intention des auteurs INDEX TO ADVERTISERS CLASSIFIED ADVERTISEMENTS , 7 Publications mailing agreement # Return undeliverable Canadian copies and change of address notifications to SOGC Subscriptions Services, 780 Echo Dr. Ottawa, Ontario K1S 5R7. JAN_JOGC cover.indd 1 12/17/2007 2:51:43 PM

2 Volume 30, Number 1 volume 30, numéro January janvier 2008 Editor-in-Chief / Rédacteur en chef Timothy Rowe CPL Editor / Rédactrice PPP Vyta Senikas Translator / Traducteur Martin Pothier Assistant Editor / Rédactrice adjointe Jane Fairbanks Editorial Assistant / Adjointe à la rédaction Daphne Sams Editorial Office / Bureau de la rédaction Journal of Obstetrics and Gynaecology Canada Room D 405A Women's Health Centre Building 4500 Oak Street Vancouver BC V6H 3N1 editor@sogc.com Tel: (604) ext Fax: (604) The Journal of Obstetrics and Gynaecology Canada (JOGC) is owned by the Society of Obstetricians and Gynaecologists of Canada (SOGC), published by the Canadian Psychiatric Association (CPA), and printed by Dollco Printing, Ottawa, ON. Le Journal d obstétrique et gynécologie du Canada (JOGC), qui relève de la Société des obstétriciens et gynécologues du Canada (SOGC), est publié par l Association des psychiatres du Canada (APC), et imprimé par Dollco Printing, Ottawa (Ontario). Publications Mail Agreement no Return undeliverable Canadian copies and change of address notices to SOGC, JOGC Subscription Service, 780 Echo Dr., Ottawa ON K1S 5R7. USPS # USPS periodical postage paid at Champlain, NY, and additional locations. Return other undeliverable copies to International Media Services, 100 Walnut St., #3, PO Box 1518, Champlain NY Numéro de convention poste-publications Retourner toutes les copies canadiennes non livrées et les avis de changement d adresse à la SOGC, Service de l abonnement au JOGC, 780, promenade Echo, Ottawa (Ontario), K1S 5R7. Numéro USPS Frais postaux USPS au tarif des périodiques payés à Champlain (NY) et autres bureaux de poste. Retourner les autres copies non livrées à International Media Services, 100 Walnut St., #3, PO Box 1518, Champlain (NY) ISSN Editorial Board / Comité de rédaction EDITOR-IN-CHIEF Timothy Rowe, MB, FRCSC University of British Columbia Vancouver, British Columbia ASSOCIATE EDITORS Maureen Heaman, RN, PhD University of Manitoba Winnipeg, Manitoba Michael Helewa, MD, FRCSC University of Manitoba Winnipeg, Manitoba John F. Jarrell, MD, MSc, FRCSC University of Calgary Calgary, Alberta Shawna L. Johnston, MD, FRCSC Queen s University Kingston, Ontario Carolyn A. Lane, MD, CCFP, FCFP University of Calgary Calgary, Alberta Helen McNamara, MD, MSc McGill University Montréal, Québec Nan Schuurmans, MD, FRCSC University of Alberta Edmonton, Alberta Vyta Senikas, MD, FRCSC SOGC, Ottawa, Ontario R. Douglas Wilson, MD, MSc, FRCSC University of Pennsylvania Philadelphia, Pennsylvania Editorial Consultants / Conseillers en rédaction Thomas Brown, PharmD University of Toronto Toronto, Ontario Jan Christilaw, MD, FRCSC, MHSc University of British Columbia Vancouver, British Columbia Paul Claman, MD, FRCSC University of Ottawa Ottawa, Ontario Joan Crane, MD, FRCSC Memorial University St. John s, Newfoundland Margo Fluker, MD, FRCSC University of British Columbia Vancouver, British Columbia International Advisory Board / Comité consultatif international Sabaratnam Arulkumaran, MBBS,DCh,FRCS(Ed),FRCOG, MD, PhD University of London London, England Jean Cohen, MD Hôpital de Sèvres Paris, France Lindsay Edouard, MB, MSc, FRCOG, FFFP United Nations Population Fund New York, U.S.A. Eileen K. Hutton, RN, RM, PhD McMaster University Hamilton, Ontario Roger A. Pierson, MS, PhD, FEAS, FCAHS University of Saskatchewan Saskatoon, Saskatchewan Marie Plante, MD, FRCSC Université Laval Québec City, Québec Benjamin K. Tsang, MSc, PhD University of Ottawa Ottawa, Ontario Ulysse Jean Gaspard, MD, PhD University of Liège Liège, Belgium Sergio Pecorelli, MD, PhD European Institute of Oncology Milan, Italy VickiL.Seltzer,MD,FACS,FACOG Albert Einstein College of Medicine New York, U.S.A. Shirish S. Sheth, MD, FRCOG, FICS Breach Candy Hospital Mumbai, India The is the official publication of, but retains editorial independence from, the following associations: Bien que le soit le journal officiel des associations suivantes, il n'en conserve pas moins son indépendance éditoriale par rapport à celles-ci : The Society of Obstetricians and Gynaecologists of Canada (SOGC) / La Société des obstétriciens et gynécologues du Canada (SOGC) The Association of Professors of Obstetrics and Gynaecology of Canada (APOG) / L Association des professeurs d obstétrique-gynécologie du Canada (APOG) The Atlantic Society of Obstetricians and Gynaecologists Association des obstétriciens et gynécologues du Québec (AOGQ) Ontario Society of Obstetricians and Gynaecologists (OSOG) / Société des obstétriciens et gynécologues de l Ontario (SOGO) Manitoba Society of Obstetricians and Gynaecologists / Société des obstétriciens et gynécologues du Manitoba Section of Obstetrics and Gynaecology, Saskatchewan Medical Association / Section d obstétrique et de gynécologie, Association médicale de la Saskatchewan Alberta Society of Obstetricians and Gynaecologists (ASOG) / Société des obstétriciens et gynécologues de l Alberta (SOGA) British Columbia Section of Obstetrics and Gynaecology Canadian Investigators in Reproduction (CIR) / Chercheurs canadiens en reproduction (CCR) Gynaecologic Oncologists of Canada (GOC) / Société des gynécologues-oncologues du Canada (SGOC) The Society of Canadian Colposcopists (SCC) / La Société canadienne des colposcopistes (SCC) JANUARY JOGC JANVIER

3 National Office / Bureau national Executive Vice-President / Vice-président administratif André B. Lalonde, MD, FRCSC Ottawa Associate Executive Vice-President / Vice-présidente administrative associée Vyta Senikas, MD, FRCSC Ottawa The Society of Obstetricians and Gynaecologists of Canada / La Société des obstétriciens et gynécologues du Canada 780 Echo Drive Ottawa, Ontario K1S 5R7 tel: (613) or fax: (613) Published for the Society of Obstetricians and Gynaecologists of Canada by the Canadian Psychiatric Association / Publié pour la Société des obstétriciens et gynécologues du Canada par l Association des psychiatres du Canada 141 Laurier Avenue West, Suite 701, Ottawa ON K1P 5J3 Managing Editor / Gestionnaire de rédaction Virginia St-Denis Editorial Coordinator and Proofreader / Coordonnateur à la rédaction et correcteur d épreuves Jonathan Cormier Desktop Publisher / Micro-éditrice Leah Tackman Periodicals Production Manager / Gestionnaire, production des periodiques Smita Hamzeh Online publishing / Publication en ligne Linda Kollesh Marketing and advertising sales / Marketing et publicité Classified advertising / Annonces classées Reprints / Tirés à part Keith Health Care Marg Churchill tel: (905) or fax: (905) mchurchill@keithhealthcare.com JOGC is indexed by the National Library of Medicine in Index Medicus and its online counterpart MEDLINE and included in NLM s PubMed system. Le JOGC est répertorié par la National Library of Medicine dans Index Medicus et son équivalent en ligne, MEDLINE. Il est également inclus dans le système PubMed de la NLM. All prescription drug advertisements have been cleared by the Pharmaceutical Advertising Advisory Board. The Society of Obstetricians and Gynaecologists of Canada La Société des obstétriciens et gynécologues du Canada Council / Conseil d administration PRESIDENT / PRÉSIDENTE Guylaine Gisèle Lefebvre, MD Toronto PAST PRESIDENT / PRÉSIDENT SORTANT Donald B. Davis, MD Medicine Hat PRESIDENT ELECT / PRÉSIDENT DÉSIGNÉ Scott Alexander Farrell, MD Halifax Regional Chairs and Alternate Chairs / Présidents et présidents suppléants régionaux WESTERN REGION / OUEST Sandra de la Ronde, MD Calgary Stephen Kaye, MD North Vancouver CENTRAL REGION / CENTRE Margaret Burnett, MD Winnipeg Annette Epp, MD Saskatoon ONTARIO REGION / ONTARIO Charmaine Roye, MD Brantford Myriam Amimi, MD Orillia QUEBEC REGION / QUÉBEC Diane Francoeur, MD Montréal Corinne Leclercq, MD Ste-Foy ATLANTIC REGION / ATLANTIQUE Terry O Grady, MD St John s Ward Murdock, MD Fredericton The JOGC, the official peer-reviewed publication of the Society of Obstetricians and Gynaecologists of Canada, is published 12 times a year. The JOGC retains editorial independence from the SOGC. The JOGC is circulated to obstetricians and gynaecologists, obstetric and gynaecology residents, family medicine specialists, family medicine residents, general practitioners, midwives, and many medical libraries, hospital and university departments of obstetrics and gynaecology, and some government offices for a total circulation of approximately This publication was developed under the direction of the JOGC Editorial Board of the Society of Obstetricians and Gynaecologists of Canada. The recommendations do not dictate an exclusive course of management and do not exclude other acceptable methods of practice. Variations which take into account the local resources and needs of the individual patient and alternatives unique to the institution or type of practice may be appropriate. Copyright 1986, 1990, 1991, 1992, 1993, 1994, 1995, 1996, 1997, 1998, 1999, 2000, 2001, 2002, 2003, 2004, 2005, 2006, Society of Obstetricians and Gynaecologists of Canada. Neither the Society nor the JOGC endorses any service or the contents of any product referred to in any advertisement in the JOGC. The SOGC and the CPA assume no responsibility or liability for damages arising from any error or omission, or from the use of any information or advice contained in the JOGC. All editorial matter in JOGC represents the opinions of the authors and not necessarily those of the SOGC or the CPA. EXECUTIVE VICE-PRESIDENT / VICE-PRÉSIDENT ADMINISTRATIF André B. Lalonde, MD Ottawa TREASURER / TRÉSORIER Mark Heywood, MD Vancouver VICE-PRESIDENTS / VICE-PRÉSIDENTS Michel Fortier, MD Québec Ahmed M. Ezzat, MD Saskatchewan OTHER REPRESENTATIVES / AUTRES REPRÉSENTANTS Junior Member / Membre débutant Christina Dolhaniuk, MD Edmonton Public / Public Maureen McTeer Ottawa Associate Member (MD) / Membre associé (MD) Owen Hughes, MD Ottawa Associate Member (RN) / Membre associé (inf. aut.) Margaret Quance RN / inf. aut. Halifax Associate Member (RM) / Membre associé (sage-femme aut.) Michelle Kryzanauskas, RM / sage-femme aut. Collingwood Corresponding Member / Membre correspondant Senator / Sénateure Lucie Pépin Ottawa APOG / APOG Patrick T. Mohide Hamilton Bien que le JOGC soit l organe officiel, revu par les pairs, de la Société des obstétriciens et gynécologues du Canada, il n entretient aucun lien de dépendance, sur le plan éditorial, avec celle-ci. Il est publié 12 fois par an à environ exemplaires et est distribué aux obstétriciens-gynécologues, aux résidents en obstétrique et en gynécologie, aux spécialistes et aux résidents en médecine familiale, ainsi qu aux généralistes et aux sages-femmes. Il est envoyé aux bibliothèques de médecine, aux départements d obstétrique et de gynécologie des hôpitaux et des universités et à certains services gouvernementaux. Cette publication a été mise au point sous la direction du comité de rédaction du JOGC de la Société des obstétriciens et gynécologues du Canada. Les recommandations n imposent pas un traitement exclusif et n excluent pas non plus d autres modes de traitement acceptables. Il est possible que des variantes qui tiennent compte des ressources locales et des exigences individuelles des patients, ainsi que des solutions propres à l institution ou au type de pratique, soient appropriées. Droit d auteur, 1986, 1990, 1991, 1992, 1993, 1994, 1995, 1996, 1997, 1998, 1999, 2000, 2001, 2002, 2003, 2004, 2005, 2006, Société des obstétriciens et gynécologues du Canada. La Société et le JOGC ne sanctionnent aucun des services ou produits mentionnés dans les réclames publicitaires du JOGC. La SOGC et l APC déclinent toute responsabilité civile ou autre quant à toute erreur ou omission, ou à l usage de tout conseil ou information figurant dans le JOGC. Tous les articles à caractère éditorial dans le JOGC représentent les opinions de leurs auteurs et non pas nécessairement celles de la SOGC ou de l APC. Toutes les annonces de médicaments prescrits ont été approuvées par le Conseil consultatif de publicité pharmaceutique JANUARY JOGC JANVIER

4 IMAGE OF THE MONTH IMAGE OF THE MONTH Congenital Atresia of the Fallopian Tube Vincent Y.T. Cheung, MBBS, FRCOG, FRCSC Department of Obstetrics and Gynaecology, North York General Hospital, University of Toronto, Toronto ON A 36-year-old woman was brought into the operating room for tubal sterilization. During laparoscopy, the proximal portion of the left fallopian tube could not be identified (Figure 1). The fimbria and the distal ampullary portion were found attached to the left pelvic sidewall near the pelvic brim (Figure 2). These structures were resected, and histological examination confirmed that they were a segment of the fallopian tube. The uterus, right fallopian tube, and both ovaries appeared normal. Right tubal coagulation was performed. Hysterosalpingography performed two months later showed a unicornuate right uterine cavity with no dye entering the left fallopian tube, supporting the impression of atresia. The patient had no history of pelvic surgery except for Caesarean section performed three years earlier. The operative report did not describe any abnormality. Atresia of the fallopian tube can be congenital or acquired (because of unrecognized torsion or ectopic pregnancy). The presence of associated uterine anomaly in this patient indicated that her tubal atresia was presumably congenital in origin. Consent to publish these images has been obtained from the patient. J Obstet Gynaecol Can 2008;30(1)11 Figure 1 Figure 2 JANUARY JOGC JANVIER

5 IMAGE DU MOIS IMAGE DU MOIS Atrésie congénitale de la trompe de Fallope Vincent Y.T. Cheung, MBBS, FRCOG, FRCSC Service d obstétrique-gynécologie, North York General Hospital, Université de Toronto, Toronto (Ont.) Une femme de 36 ans a été admise à la salle d opération en vue d une stérilisation tubaire. Au cours de la laparoscopie, la partie proximale de la trompe de Fallope gauche n a pu être identifiée (Figure 1). Les franges du pavillon de la trompe et la partie ampullaire distale de celle-ci étaient fixées à la paroi pelvienne latérale gauche, près du bord pelvien (Figure 2). Ces structures ont été réséquées et l examen histologique a confirmé qu il s agissait d un segment de la trompe de Fallope. L utérus, la trompe de Fallope droite et les deux ovaires semblaient normaux. Une coagulation tubaire droite a été effectuée. Une hystérosalpingographie effectuée deux mois plus tard indiquait la présence d une cavité utérine droite unicorne et révélait que le colorant ne pouvait pénétrer dans la trompe de Fallope gauche, ce qui soutenait l impression d atrésie. La patiente ne présentait aucun antécédent de chirurgie pelvienne, exception faite d une césarienne effectuée trois ans plus tôt. Le protocole opératoire ne décrivait aucune anomalie. L atrésie de la trompe de Fallope peut être congénitale ou acquise (en raison d une torsion non reconnue ou d une grossesse ectopique). La présence d une anomalie utérine connexe chez cette patiente indiquait que son atrésie tubaire était vraisemblablement d origine congénitale. La patiente a consenti à la publication de ces images. J Obstet Gynaecol Can, vol. 30, n 1, 2008, p. 12 Figure 1 Figure 2 12 JANUARY JOGC JANVIER 2008

6 GUEST EDITORIAL GUEST EDITORIAL Prenatal Choices for Canadian Women: Individual Choice or the Public Good? R. Douglas Wilson, MD University of Pennsylvania, Philadelphia PA The SOGC Clinical Practice Guideline on Prenatal Screening for Fetal Aneuploidy, 1 published last February, included the recommendation that all pregnant woman should be offered ultrasound and biochemical testing in the first or second trimester, which, together with maternal age, would determine the likelihood of a chromosomal abnormality (trisomy 21 and 18) or a congenital fetal anomaly (neural tube defect, abdominal wall defect, or renal defect) and would detect a multiple pregnancy. The pre-existing indication for direct access to invasive genetic testing, that of being age 35 at the estimated date of delivery (EDD), is no longer considered appropriate. In addition to the above, biochemical screening can also identify risks for intrauterine fetal death and rare genetic conditions, such as X-linked ichthyosis and Smith-LemliOpitz syndrome. In an individual woman, if the calculated risk for aneuploidy or congenital anomaly is above the level established by the screening program, then the woman is offered more specific testing by means of amniocentesis, chorionic villus sampling, or ultrasound alone. Women who will be over the age of 40 at EDD are given the option of undergoing the screening protocols or proceeding directly to diagnostic testing (amniocentesis, chorionic villus sampling) because of their a priori increased risk of a fetal chromosomal anomaly. Using a maternal age of 40 at EDD as an indication for direct access to diagnostic testing was a change from the previously recommended age cut-off of 35 years at EDD. 2 This new recommendation was made partly because of the improved detection rate of biochemical and/or ultrasound screening, and partly to reduce the unintended fetal loss rates resulting from complications of amniocentesis. The SOGC s Genetics Committee has concluded that the best current estimate of the post-amniocentesis unintended fetal loss rate is 1 in procedures, using large published J Obstet Gynaecol Can 2008;30(1):13 14 cohort studies but only one specific randomized controlled trial. 3,4 An additional benefit of having pregnant women undergo serum screening is that it may provide predictions for the risk of other obstetrical complications, such as hypertension, preeclampsia, or intrauterine growth restriction. The American College of Obstetricians and Gynecologists (ACOG) published a Practice Bulletin containing guidelines for Screening for Fetal Chromosomal Abnormalities in January This publication received more media coverage in Canada than the SOGC guideline published one month later. The ACOG guideline left the decision about fetal chromosomal risk assessment to the pregnant woman and her doctor, indicating that the woman should decide whether she considers her personal risk to be at a level that she wishes to have diagnostic testing (amniocentesis, chorionic villus sampling), with the cost being covered by her private insurance carrier or by the patient. The ACOG guideline recommended maternal serum screening (first or second trimester protocols) for all pregnant women and the removal of age 35 as a specific threshold for increased risk, but left the decision about undergoing invasive diagnostic testing to the patient. This point is a major difference between the ACOG individual choice approach and the SOGC public health approach requiring specific fetal chromosomal risk criteria to be met before access to invasive testing is available within the governmentsupported health care system. Which is the better comprehensive approach for prenatal screening and testing? Is it the individual choice / informed consent (ACOG) approach, or is it the public health (SOGC) approach? Should we members of SOGC strongly endorse, educate, counsel, and advocate for the public system with its variable access and its unequal standard of care and level of provincial funding? Or should we accept that pregnant women, after appropriate, balanced, non-directive counselling can say yes, my screening was negative, but, on the basis of my understanding of benefit and risk, I still JANUARY JOGC JANVIER

7 GUEST EDITORIAL want to have a fetal chromosomal analysis? The latter echoes the issue of primary Caesarean section on maternal request. Decisions in this area should not be based on the medicallegal consequences (as with the ACOG recommendations), on purely economic restrictions (provincial health budgets), or on specific screening criteria (as with the SOGC recommendations); instead, they should be based on doing the right thing to balance the public good and the needs of the pregnant woman whose family history causes her doubt that her pregnancy will have a healthy outcome. To allow individual freedom of choice within a capitated public health care system is a difficult challenge that will require further debate among patients, health care professionals, ethicists, patient advocate groups, and funding agencies. The final decision to undergo invasive fetal testing should be left to each woman; the decision must be preceded by a comprehensive informed consent process, and there should be an option for the patient to pay for testing within the capitated health care system. The SOGC Guideline 1 and Genetics Committee Opinion 4 have attempted to balance these issues, but the contributors recognize that public and individual needs cannot be met for all jurisdictions. The SOGC documents are reviewed every two to three years, or more often if important new information becomes available or if changes in health care funding are made. The overall principles governing counselling, testing, and treatment are to do no harm, and to follow the CanMEDS roles described by the Royal College of Physician and Surgeons of Canada. These roles are professional, communicator, collaborator, health advocate, scholar, medical expert, and manager for providing optimal patient care and pregnancy outcomes in 2007 and beyond. REFERENCES 1. Summers AM, Langlois S, Wyatt P, Wilson RD. Prenatal screening for fetal aneuploidy. SOGC Clinical Practice Guideline, No. 187, February J Obstet Gynaecol Can 2007;29(2): Chodirker BM, Cadrin C, Davies GAL, Summers AM, Wilson RD, Winsor EJT, et al. Canadian guidelines for prenatal diagnosis: genetic indications for prenatal diagnosis. SOGC Clinical Practice Guideline, No. 105, June J Soc Obstet Gynaecol 2001;23(6): Wilson RD. Amended Canadian guideline for prenatal diagnosis (2005) change to 2005 techniques for prenatal diagnosis. SOGC Clinical Practice Guidelines, No. 168, November J Obstet Gynaecol Can 2005;27(11): Wilson RD, Langlois S, Johnson J-A. Mid-trimester amniocentesis fetal loss rate. SOGC Committee Opinion, No. 194, July J Obstet Gynaecol Can 2007;29(7): Screening for fetal chromosomal abnormalities. ACOG Practice Bulletin. 6. No. 77. American College of Obstetricians and Gynecologists. Obstet Gynecol 2007;109: JANUARY JOGC JANVIER 2008

8 ÉDITORIAL SOLLICITÉ ÉDITORIAL SOLLICITÉ Choix prénatals offerts aux Canadiennes : Liberté de choix ou bien public? R. Douglas Wilson, MD Université de Pennsylvania, Philadelphie (PA) La directive clinique de la SOGC sur le dépistage prénatal de l aneuploïdie fœtale 1, publiée en février dernier, comptait la recommandation selon laquelle toutes les femmes enceintes devraient se voir offrir un dépistage échographique et biochimique au cours du premier ou du deuxième trimestre, les résultats duquel (évalués conjointement avec l âge maternel) permettraient de déterminer la probabilité de constater une anomalie chromosomique (trisomies 21 et 18) ou une anomalie fœtale congénitale (anomalie du tube neural, anomalie de la paroi abdominale ou anomalie rénale) et de détecter la présence d une grossesse multiple. L indication préexistante en ce qui concerne l accès direct au dépistage génétique effractif (soit l âge de 35 ans à la date probable d accouchement [DPA]) n est plus considérée appropriée. En plus des caractéristiques susmentionnées, le dépistage biochimique peut également déterminer les risques de décès fœtal intra-utérin et de constater la présence de pathologies génétiques rares, telles que l ichtyose liée au chromosome X et le syndrome de Smith-Lemli-Opitz. Chez une patiente donnée, lorsque le risque calculé en ce qui a trait à l aneuploïdie ou les anomalies congénitales se situe au-delà de la valeur établie par le programme de dépistage, la patiente en question se voit offrir un dépistage plus pointu faisant appel à l amniocentèse, au prélèvement de villosités choriales ou à la seule échographie. Les femmes qui auront plus de 40 ans au moment de la DPA se voient offrir le choix de se soumettre aux protocoles de dépistage ou de passer directement au dépistage diagnostique (amniocentèse, prélèvement de villosités choriales) en raison de leur risque a priori accru de présenter une anomalie chromosomique fœtale. Le fait d utiliser un âge maternel de 40 ans au moment de la DPA à titre d indication pour l accès direct au dépistage J Obstet Gynaecol Can, vol. 30, n 1, 2008, p diagnostique constituait un changement par rapport à l âge-seuil auparavant recommandé (35 ans au moment de la DPA) 2. Cette nouvelle recommandation a été formulée en partie en raison de l amélioration du taux de détection du dépistage biochimique et/ou échographique, et en partie en vue de réduire les taux de perte fœtale accidentelle attribuable aux complications de l amniocentèse. En se fondant sur des études de cohorte publiées de grande envergure (mais sur seulement un essai comparatif randomisé particulier), le comité sur la génétique de la SOGC en est arrivé à la conclusion que, à l heure actuelle, la meilleure estimation du taux de perte fœtale accidentelle post-amniocentèse est de 1 sur interventions 3,4. Le dépistage sérique peut permettre de prédire le risque de présenter d autres complications obstétricales (telles que l hypertension, la prééclampsie ou le retard de croissance intra-utérin), ce qui en constitue un des avantages supplémentaires pour les femmes enceintes. Le American College of Obstetricians and Gynecologists (ACOG) a publié un document (Practice Bulletin) contenant des lignes directrices pour le dépistage des anomalies chromosomiques fœtales (intitulées Screening for Fetal Chromosomal Abnormalities) en janvier Cette publication a bénéficié, au Canada, d une couverture médiatique plus importante que celle qui a été accordée à la directive clinique de la SOGC ayant été publiée un mois plus tard. Selon la directive clinique de l ACOG, la décision quant à l évaluation du risque chromosomique fœtal devrait revenir à la femme enceinte et à son médecin; l ACOG est donc d avis que la patiente devrait déterminer elle-même le seuil de risque personnel au-delà duquel elle souhaiterait avoir recours au dépistage diagnostique (amniocentèse, prélèvement de villosités choriales), les coûts étant assumés par la patiente en question ou sa police d assurance privée. Bien que la directive clinique de l ACOG ait recommandé le dépistage sérique maternel (protocoles du premier ou du deuxième trimestre) pour toutes les femmes enceintes et l abolition du seuil de 35 ans à titre d indicateur particulier JANUARY JOGC JANVIER

9 ÉDITORIAL SOLLICITÉ d une hausse du risque, elle indiquait également que la décision d avoir recours ou non au dépistage diagnostique effractif devait revenir à la patiente. Cet élément constitue une des différences importantes entre l approche «choix personnel» de l ACOG et l approche «santé publique» de la SOGC (laquelle exige la présence de critères de risque chromosomique fœtal particuliers avant de permettre l accès au dépistage effractif dans le cadre du système de soins de santé financé par l État). Quelle est la meilleure et la plus exhaustive des approches en matière de dépistage prénatal? L approche «choix personnel / consentement éclairé» (ACOG) ou l approche «santé publique» (SOGC)? Devrions-nous, à titre de membres de la SOGC, soutenir, éclairer, conseiller et défendre avec vigueur le système public, et ce, malgré le caractère variable de l accès aux soins et l inégalité des normes de soins et des taux de financement provinciaux? Ou devrions-nous accepter que les femmes enceintes, après avoir bénéficié de conseils appropriés, objectifs et non directifs, sont pleinement en mesure d affirmer que «oui, les résultats de mon dépistage sont négatifs, mais, en fonction de ma compréhension du rapport avantages-risques, je souhaite tout de même avoir recours à l analyse chromosomique fœtale»? Le débat entourant cette question rappelle celui qui a entouré celle de la césarienne de convenance. Dans ce domaine, les décisions ne devraient pas être fondées sur les conséquences médico-juridiques (comme dans le cas des recommandations de l ACOG), sur des considérations purement économiques (budgets provinciaux en matière de santé) ni sur des critères de dépistage particuliers (comme dans le cas des recommandations de la SOGC); elles devraient plutôt s efforcer de mettre en balance le bien public et les besoins de la femme enceinte dont les antécédents familiaux la pousse à douter de l obtention d une issue de grossesse souhaitable. Le respect de la liberté de choix des patientes au sein d un système de santé public fonctionnant par capitation représente un défi complexe qui nécessite la tenue d un débat élargi entre les patientes, les professionnels de la santé, les éthiciens, les groupes de défense des droits des patientes et les organismes de financement. La décision finale quant au recours au dépistage fœtal effractif devrait revenir à la patiente; cette décision doit être précédée d un processus exhaustif menant au consentement éclairé. De plus, la patiente devrait disposer de l option d assumer les coûts du dépistage au sein du système de santé fonctionnant par capitation. Bien que la directive clinique 1 et l opinion du comité sur la génétique 4 de la SOGC aient tenté de mettre en balance les différents aspects de ces questions, les collaborateurs reconnaissent qu il est impossible de satisfaire les besoins publics et personnels au sein de tous les territoires de compétence. Les documents de la SOGC sont révisés tous les deux à trois ans, ou plus souvent lorsque surgissent de nouveaux renseignements importants ou lorsque des modifications sont apportées au financement des soins de santé. Les principes globaux régissant le counseling, le dépistage et le traitement sont de ne pas causer de torts et de respecter les rôles CanMEDS décrits par le Collège royal des médecins et chirurgiens du Canada. Ces rôles sont ceux d expert médical, de communicateur, de collaborateur, de promoteur de la santé, de gestionnaire, d érudit et de professionnel; ils contribuent tous à l offre de soins optimaux aux patientes et à l obtention des meilleures issues de grossesse en 2007 et pour les années à venir. RÉFÉRENCES 1. Summers AM, Langlois S, Wyatt P, Wilson RD. «Dépistage prénatal de l aneuploïdie fœtale. Directive clinique de la SOGC, n 187, février 2007», J Obstet Gynaecol Can, vol. 29, n 2, 2007, p Chodirker BM, Cadrin C, Davies GAL, Summers AM, Wilson RD, Winsor EJT, et coll. «Lignes directrices canadiennes sur le diagnostic prénatal : indications génétiques pour un diagnostic prénatal. Directive clinique de la SOGC, n 105, juin 2001», J Obstet Gynaecol Can, vol. 23, n 6, 2001, p Wilson RD. «Lignes directrices canadiennes modifiées sur le diagnostic prénatal (2005) Techniques de diagnostic prénatal. Directive clinique de la SOGC, n 168, novembre 2005», J Obstet Gynaecol Can, vol. 27, n 11, 2005, p Wilson RD, Langlois S, Johnson J-A. «Taux de perte fœtale associée à l amniocentèse menée au cours du deuxième trimestre. Opinion de comité de la SOGC, n 194, juillet 2007», J Obstet Gynaecol Can, vol. 29, n 7, 2007, p «Screening for fetal chromosomal abnormalities. ACOG Practice Bulletin. 6. No. 77. American College of Obstetricians and Gynecologists», Obstet Gynecol, vol. 109, 2007, p JANUARY JOGC JANVIER 2008

10 OBSTETRICS OBSTETRICS Prenatal HIV Testing: Women s Experiences of Informed Consent in Toronto, Ontario Dale Guenter, MD, MPH, 1 Angela M. Barbara, MS, 1 Randi Zlotnik Shaul, LLM, PhD, 2 Mark H. Yudin, MD, MSc, 3 Robert S. Remis, MD, 4 Susan M. King, MD 5 1 Department of Family Medicine, McMaster University, Hamilton ON 2 Department of Bioethics, The Hospital for Sick Children, University of Toronto, Toronto ON 3 Department of Obstetrics, University of Toronto and St. Michael s Hospital, Toronto ON 4 Department of Public Health Sciences, University of Toronto, Toronto ON 5 Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto ON Abstract Objective: All Canadian jurisdictions have human immunodeficiency virus (HIV) testing programs requiring that clinicians discuss HIV testing with all pregnant women and seek their consent to be tested. Our goal was to evaluate how the informed consent process was being carried out in Ontario. Methods: Between November 2002 and February 2004, women in postpartum wards in three Toronto teaching hospitals were invited to participate in the study. A structured questionnaire was administered on the ward, medical records were reviewed, and data from the Central Public Health Laboratory were examined to verify whether or not the women had been tested. Results: Of 446 women invited, 299 (67%) participated. All except one participant had at least one prenatal visit, and 92% had more than five visits. Seventy-four percent of participants recalled a clinician talking to them about testing, and 70% of these felt that they were given the option to refuse the test. Twenty-one women overall (7%) believed that they were not tested during pregnancy or were not certain whether they had been tested or not, but actually had been tested. Women who felt that their care provider did not have an opinion about whether they should undergo testing were more likely to decline. Eighty-six percent were completely satisfied with the testing experience. Conclusion: Informed consent for prenatal HIV testing is generally being obtained in a manner consistent with provincial guidelines. Our findings raise concern, however, that a significant number of women are not offered testing or in some cases are tested without their consent. Increases in testing rates could be achieved by offering the test to all women and emphasizing that carrying out testing is a recommended part of medical care. Key Words: HIV serodiagnosis, prevention, prenatal care, informed consent, health care ethics, program evaluation Competing Interests: None declared. Received on May 8, 2007 Accepted on June 20, 2007 Résumé Objectif : Tous les territoires de compétence canadiens disposent de programmes de dépistage du virus de l immunodéficience humaine (VIH) qui exigent des cliniciens qu ils discutent du dépistage du VIH avec toutes les femmes enceintes et cherchent à obtenir leur consentement quant à la tenue de ce dépistage. Notre objectif était d évaluer la façon dont le processus de consentement éclairé était mis en œuvre en Ontario. Méthodes : Entre novembre 2002 et février 2004, les femmes des salles post-partum de trois hôpitaux universitaires torontois ont été invitées à participer à l étude. Un questionnaire structuré leur a été administré, leurs dossiers médicaux ont été analysés et les données du Laboratoire central de santé publique ont été examinées afin de vérifier si les femmes en question avaient bel et bien fait l objet d un dépistage. Résultats : Deux cent quatre-vingt-dix-neuf (67 %) des 446 femmes sollicitées ont participé à l étude. Toutes les participantes sauf une avaient bénéficié d au moins une consultation prénatale; 92 % d entre elles avaient bénéficié de plus de cinq consultations. Soixante-quatorze pour cent des participantes se rappelaient qu un clinicien leur avait parlé du dépistage et 70 % d entre elles étaient d avis qu elles avaient disposé de l option de refuser le test. En tout, 21 femmes (7 %) estimaient qu elles n avaient pas fait l objet d un test de dépistage au cours de la grossesse ou n étaient pas certaines d en avoir fait l objet, alors qu elles en avaient toutes bel et bien fait l objet. Les femmes qui étaient d avis que leur fournisseur de soins n avait pas exprimé d opinion au sujet de la nécessité du dépistage dans leur cas étaient plus susceptibles de refuser de s y soumettre. Quatre-vingt-six pour cent des participantes étaient entièrement satisfaites de leur expérience en matière de dépistage. Conclusion : Le consentement éclairé en matière de dépistage prénatal du VIH est généralement obtenu de manière conforme aux lignes directrices provinciales. Cependant, nos résultats indiquent qu un nombre significatif de femmes ne se voient pas offrir le dépistage et que ce dernier s effectue sans consentement dans certains cas, ce qui soulève certaines préoccupations. L offre du test à toutes les femmes et la mise d un accent particulier sur le fait que la mise en œuvre du dépistage s inscrit dans le cadre des soins médicaux recommandés pourraient entraîner la hausse des taux de dépistage. J Obstet Gynaecol Can 2008;30(1):17 22 JANUARY JOGC JANVIER

11 OBSTETRICS INTRODUCTION Health ministries in all provincial and territorial jurisdictions in Canada now have programs that require human immunodeficiency virus (HIV) testing to be offered to all pregnant women, regardless of their risk for contracting HIV. 1 They also require that women be given an opportunity to accept or decline testing. These principles have been supported by the guidelines of a variety of professional associations. 2 4 Ontario s Ministry of Health and Long-Term Care changed its program from targeted to universal voluntary testing with informed consent in December This approach has resulted in some increase in testing rates: approximately 50% of pregnant women were being tested at the time this study started in 2001, and by 2003, the rate was 85%. Testing remained at this level until However, very little information that describes the quality of the informed consent component of the program is available, and the objective of our study was to evaluate this aspect. There are several reasons for adopting a universal approach to prenatal HIV testing. First, the number of women infected with HIV in Canada is rising, with 2 9/ women of childbearing age infected. 1 Second, a marked reduction in perinatal HIV transmission, from approximately 25% to less than 1%, can be achieved by using antiretroviral therapy during pregnancy and in the newborn and by not breast feeding. 6 8 Finally, targeted HIV testing that is based on risk factors will fail to screen a large proportion of women who are actually HIV positive, since their only risk is having sex with one man of unknown HIV status An important difference among provincial and territorial HIV testing programs in Canada is the way in which informed consent is applied. In jurisdictions with the opt-in approach, of which Ontario is an example, women receive information about testing and an opportunity to consent to testing. In the opt-out approach, women are told that testing is a routine procedure, are given information about the test, and have the opportunity to decline testing. The benefits and limitations of each approach have been widely debated in Canada and the US The opt-in approach is often promoted as more patient-centred and ethically sound. Canadian jurisdictions adopting the opt-out method have, however, generally achieved higher testing rates (of close to 100%), while the rates for opt-in provinces have been less than 90%. 1 Recent guidelines, including those of Ontario Ministry of Health and Long-Term Care, encourage clinicians to include specific elements in the informed consent process. 15 These include explaining that the test is a standard of care and is recommended for all women, reviewing the benefits and risks of the test, discussing the voluntary nature of the test, and documenting whether or not the woman consents to be tested. In addition, guidelines recommend testing later in pregnancy if the woman declines the first offer and addressing concerns about HIV prevention and risk behaviours. The primary purpose of our study was to evaluate women s perceptions of the informed consent process. Secondary objectives were to ascertain whether the women were aware that a test had been done and, if they declined testing, why they did so. We have previously reported our findings with respect to the problems with accuracy of hospital records and women s self-report for determining whether HIV testing was carried out; these findings were based on an analysis of different data pertaining to the same study participants. 16 METHODS The methodology for recruiting study participants and collecting data has been previously described. 16 Data were collected between November 2002 and February The research protocol was approved by research ethics committees at the study sites as well as The Hospital for Sick Children and the University of Toronto. Study participants were recruited on the postpartum wards of three Toronto tertiary care teaching hospitals that have a total of approximately births annually: St. Michael s Hospital, Mount Sinai Hospital, and the Women s College Campus of Sunnybrook and Women s College Hospital. One interviewer (AMB) carried out all interviews and was present on a ward during daytime hours on weekdays, inviting all women on the ward to participate in the study. Recruitment stopped when the target of 100 participants at each site was achieved. All women who understood and spoke English well enough to complete a personal interview were eligible. Following informed consent, the interviewer administered a structured questionnaire concerning the women s experience of HIV counselling and testing during the current pregnancy. Health records were also reviewed for prenatal and obstetrical information. Databases of the Central Public Health Laboratory, where all HIV tests in Ontario are carried out, were searched to determine whether or not HIV testing had been completed for each participant during the nine months prior to delivery, but not to determine the result of the test. All data were entered into a database and analyzed using SPSS (SPSS for Windows, Chicago, IL). Descriptive analyses were performed, and the Pearson chi-square test was used to test the significance of differences in proportions where appropriate. 18 JANUARY JOGC JANVIER 2008

12 Prenatal HIV Testing: Women s Experiences of Informed Consent in Toronto, Ontario RESULTS Characteristics of Study Participants The demographic and obstetrical characteristics of study participants are shown in Table 1. Of 446 women invited to participate, 299 (67%) agreed to do so. Many of the participants were born outside Canada and primarily spoke a language other than English. Most participants were married and had completed post-secondary education. Only one participant had not received any prenatal care; 92% had more than five prenatal visits. Prenatal care was provided exclusively by obstetricians for 67%, while 16% received care from both an obstetrician and a family physician, 13% from a family physician only, 2% from a midwife, and 1% from some other combination of providers. Perceptions of Informed Consent for Testing The informed consent experience for HIV testing is described in Table 2. Of 299 women, 220 (74%) answered yes to the question Did any health care provider talk to you about having an HIV test? These women were further questioned about their experience of being offered the test. One hundred fifty-nine (72%) of the 220 women who were approached about testing reported that the health care provider talked generally about HIV infection with them. Most had the impression that the test was a routine procedure and that they had the option to decline testing. The perceptions that women had about the strength of the health care provider s recommendation to be tested are shown in Table 3. When asked to choose one of five statements that best described the message the provider conveyed when talking about testing, 25% felt that the decision to test was completely their own, with no opinion from the provider; the remainder believed the health care provider was to some degree encouraging them to be tested. Accuracy of Recall of Testing How women s perceptions of the informed consent process compare with laboratory evidence of their having been tested or not is described in Table 4. There was laboratory evidence of testing being carried out during pregnancy for 193 (65%) of the 299 participants, including two women (0.7%) who recalled declining testing, two (0.7%) who were not certain, and 17 (5.7%) who were not offered testing and believed they were not tested. Twenty-two women (7.4%) recalled having no discussion about testing but accurately assumed they had been tested. Eighty-three women (28%) who believed they were tested in fact were not. Of the 197 women who accepted the HIV test offer, 171 (87%) reported that they had received their test results. Table 1. Demographic and obstetrical characteristics of study participants Participants Characteristic n = 299 n (%) Age (years) (2.0) (21) (70) (5.7) Relationship Status Married 255 (85) Common law partner 24 (8.0) Single, no partner 13 (4.3) Coupled, not living together 7 (2.3) Separated/divorced 0 Country of Birth Canada 172 (58) Country of Residence Have lived outside Canada 3 months 179 (60) First Language English 208 (70) Education Some high school 8 (2.7) High school diploma 38 (13) Some post-secondary 19 (6.3) Bachelor s degree 177 (59) Master s degree 42 (14) PhD or more 14 (4.7) Pregnancy History (parity) (59) 1 89 (30) 2 25 (8.4) 3 or more 6 (2.0) Duration of Gestation (weeks, mean = 39) (0.7) (7.7) (91) Mode of Delivery Vaginal 175 (59) Elective Caesarean section 55 (18) Urgent Caesarean section 36 (12) Emergency Caesarean section 31 (10) Number of Weeks at 1st Prenatal Visit (mean = 14) (53) (25) (11) Number of Prenatal Visits (mean = 9) (0.3) 22 (7.4) (78) (4.0) Data extracted from medical record. JANUARY JOGC JANVIER

13 OBSTETRICS Table 2. Perceptions of informed consent process Statement The HIV test was a routine test, the same as all the other prenatal blood tests. I had the option to refuse the HIV test if I wanted to. I wish I had more information before making a decision about the HIV test. I was completely satisfied with how the test was explained to me. No. (%) who agreed 174 (79) 153 (70) 30 (14) 189 (86) Table 3. Strength of clinician s recommendation to be tested Statement: I felt the health care provider was (choose one)... No. (%) Simply informing me that the test was routine, and that it would be ordered with all the other prenatal blood tests. 124 (56) Strongly recommending that I have the test. 27 (12) Somewhat recommending that I have the test. 8 (3.6) Leaving the decision to test completely up to me. 56 (25) Discouraging me from having the HIV test. 0 (0) Table 4. Informed consent recall compared with laboratory evidence of testing Actually Tested According to Laboratory Databases Informed Consent Recall Yes, n (%) No, n (%) Total, n (%) Discussed and 150 (50) 47 (16) 197 (66) accepted testing Discussed and 2 (0.7) 16 (5.4) 18 (6.0) declined testing Discussed and not 2 (0.7) 3 (1.0) 5 (1.7) sure if tested Not discussed and 17 (5.7) 4 (1.3) 21 (7) not tested Not discussed and 22 (7.4) 36 (12) 58 (19) tested Total 193 (65) 106 (35) 299 (100) Reasons for Declining Testing We asked the 18 women who said they had declined the offer of HIV testing to identify the most important reason for their decision. Nine said they had been tested before this pregnancy and believed they did not need to test again, seven felt they were not at risk for HIV, one had no need for HIV testing, and one intended to undergo testing but did not. The significant differences between women who accepted HIV testing and women who declined were that non-testers were (1) more likely to have had a nurse discuss the HIV test with them (28% vs. 6%, P = 0.03), (2) less likely to agree that the test was explained to them as a routine prenatal blood test (44% vs. 83%, P = 0.003), and (3) more likely to feel that the decision to undergo testing was left completely up to them (72% vs. 22%, P < 0.001). There were no significant differences in age, country of birth, ethnocultural background, language, relationship status, level of education, pregnancy history, HIV testing history, timing of first prenatal visit, number of prenatal visits, or satisfaction with the HIV test explanation between women who accepted HIV testing and those who declined. DISCUSSION A majority of women in our study reported HIV testing experiences that are consistent with the guidelines of Ontario s prenatal HIV testing program. Most could recall being approached about testing, most understood the test to be a standard procedure for all women, most felt the provider was advising them to be tested, and most felt they had the option to decline testing. Our findings do, however, raise several concerns about the informed consent process being used by prenatal care providers in Toronto. About one quarter of the participants did not recall any mention of testing, and a small but significant number of women were not aware that they had actually been tested. Not surprisingly, women who declined testing were less likely to feel that their prenatal care provider was encouraging them to undergo testing. Because only 14% of our participants felt that they needed more information than they received, and 86% were completely satisfied with how the test was explained, it seems that the informed consent process is, in general, meeting women s expectations. A similar study by Perez et al. reported data from postpartum women in Spain in 2000 and found that 10.7% of women who had been tested were unaware that they had been, a finding similar to ours. 17 In a province-wide study of prenatal care providers in Ontario carried out in 2000, 65% reported offering HIV testing to all pregnant women, most clinicians were conveying the message that prenatal HIV testing is standard for all pregnant women, and rates of testing were higher when discussion of testing was accompanied by a stronger recommendation. 18,19 The description 20 JANUARY JOGC JANVIER 2008

14 Prenatal HIV Testing: Women s Experiences of Informed Consent in Toronto, Ontario given by women in the current study is consistent with the previous studies among clinicians. The current study was carried out at a time when testing rates in Ontario were increasing, from about 50% when the study started to 85% when it was completed. We would expect that the practices of health care providers were also changing during that time as they became more comfortable with adopting the relatively new guidelines for HIV testing. Since this study was completed, testing rates in Ontario have changed very little, and achieving the near-complete testing rates of the jurisdictions with opt-out programs (Nunavut, Northwest Territories, Alberta, Nova Scotia, Newfoundland and Labrador) has been challenging. 20,21 The Centers for Disease Control and Prevention in the US have recently moved to recommend an opt-out approach to testing, and continues to emphasize the voluntary nature of the test. 22 Opt-out programs are likely to provide stronger reinforcement of prenatal HIV testing as a standard procedure. We are not aware, however, of any evaluation of the quality of the informed consent process in jurisdictions that have adopted this approach. There are several important limitations of our study. Since our findings were concerned with women s perceptions rather than clinical observations, we cannot draw conclusions about what actually took place in the clinical event. Because this was a retrospective study, there are likely to be inaccuracies in the recall of our participants, which could account for the lack of consistency between laboratory data and self-report about having been tested. Our data draw on a somewhat unusual group of postpartum women. Although our sample had considerable demographic diversity, many participants were highly educated, all were capable of being interviewed in English, most received substantial prenatal care, all had completed their pregnancies, and all participants delivered their babies in a Toronto teaching hospital. This limits the degree to which our results may be generalized to a broader population and highlights the importance of further study of groups not represented in our sample. Our sample was also robust in several regards. It was drawn from a population of women who were at the same stage in their pregnancies. They were recruited through direct personal invitation by a single researcher, rather than by convenience participation, at multiple sites, and without selection bias. Their interviews were completely independent of their health care and their care providers. These qualities increase our confidence in the reliability and generalizability of the results. CONCLUSION In women delivering in the study sites during the time this study was conducted, informed consent for prenatal HIV testing was being obtained in a manner that was generally in keeping with provincial program guidelines. At the same time, our findings highlight the need to increase the number of women who are offered testing, the need to reinforce with clinicians that testing is voluntary, and the need to emphasize that women should not be tested without their knowledge. Rates of testing for HIV during pregnancy could be improved if clinicians offered testing to more women and emphasized that it is strongly recommended as a standard part of prenatal care. ACKNOWLEDGMENTS We recognize the support of the Ontario HIV Treatment Network, which funded this research, the many women who contributed their personal experiences, and the hospital staff who worked closely with us to gather the data. REFERENCES 1. Public Health Agency of Canada. HIV/AIDS Epi Updates, August 2006, Surveillance and Risk Assessment Division, Centre for Infectious Disease Prevention and Control, Public Health Agency of Canada, Samson LM, King S. Evidence-based guidelines for universal counselling and offering of HIV testing in pregnancy in Canada. CMAJ 1998;158: Canadian Paediatric Society. Testing for human immunodeficiency virus type I (HIV-1) infection in pregnancy. J Paediatr Child Health 2001;6(9): Keenan-Lindsay L, Yudin MH; SOGC Infectious Diseases Committee. HIV screening in pregnancy. SOGC Clinical Practice Guidelines, No. 185, December J Obstet Gynaecol Can 2006;28(12): Silversides A. Ontario joins prenatal HIV-screening movement. CMAJ 1999;160: Ioannidis JP, Abrams EJ, Ammana A, Bulterys M, Goedert JJ, Gray L, et al. Perinatal transmission of human immunodeficiency virus type 1 by pregnant women with RNA virus loads < 1000 copies/ml. J Inf Dis 2001;183: Watts DH. Management of human immunodeficiency virus infection in pregnancy. N Engl J Med 2002;346: Burdge DR, Mondy DM, Forbes JC, Walmsley SL, Smaill FM, Boucher M, et al. Canadian consensus guidelines for the management of pregnant HIV-positive women and their offspring. CMAJ 2003;168: Ades AE, Gupta R, Gibb DM, Duong T, Nicoll A, Goldberg D, et al. Selective versus universal antenatal HIV testing: epidemiological and implementational factors in policy choice. AIDS 1999;13(12): Barbacci MB, Dalabetta GA, Repke JT, Talbot BL, Charache P, Polk BF, et al. Human immunodeficiency virus infection in women attending an inner-city prenatal clinic: ineffectiveness of targeted screening. Sex Transm Dis 1990;17(3): Fehrs LJ, Hill D, Kerndt PR, Rose TP, Henneman C. Targeted HIV screening at a Los Angeles prenatal/family planning health center. Am J Pub H 1991;81: O Connor KS, Macdonald SE. Aiming for zero: preventing mother-to-child transmission of HIV [commentary]. CMAJ 2002;166: Walmsley S. Opt in or opt out: what is optimal for prenatal screening for HIV infection? CMAJ 2003;168: JANUARY JOGC JANVIER

15 OBSTETRICS 14. Sherr L, Bergenstrom A, Hudson CN. Consent and antenatal HIV testing: the limits of choice and issues of consent in HIV and AIDS. AIDS Care 2000;12: Ontario Ministry of Health and Long-Term Care. Discussion Guide for Providers for Prenatal HIV Testing. Available at: english/providers/pub/aids/prenatal/prenatal/discussion_e.pdf Accessed April 30, Yudin MH, Barbara AM, Guenter D, Zlotnik Shaul R, Remis R, King S. Clinical records and women s self report are not reliable sources for determining whether prenatal HIV testing was done. J Obstet Gynaecol Can 2006;28(10): Perez K, Blanch C, Casabona J, Almeda J, Coll C. Coverage of HIV testing among women in Catalonia, Spain: a comparison of self-reporting with medical records. Eur J Public Health 2004;14: Guenter D, Carroll J, Kaczorowski J, Sellors J. Prenatal HIV testing in Ontario: knowledge, attitudes and practices of prenatal care providers in a province with low testing rates. Can J Public Health 2003; 94: Guenter D, Kaczorowski J, Carroll J, Sellors J. (2003). Prenatal HIV tests: Routine testing or informed choice? Can Fam Physician 2003;49: Jayaraman GC, Preiksaitis JK, Larke B. Mandatory reporting of HIV infection and opt-out prenatal screening for HIV infection: Effect on testing rates. CMAJ 2003;168: Mossman CL, Ratnam S. Opt-out prenatal HIV testing in Newfoundland and Labrador. CMAJ 2002;167: Branson BM, Handsfield HH, Lampe MA, Janssen RS, Taylor AW, Lyss SB, et al. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR Recomm Rep 2006;55(RR-14): JANUARY JOGC JANVIER 2008

16 OBSTETRICS OBSTETRICS Factors Associated With a Successful External Cephalic Version in the Early ECV Trial Eileen K. Hutton, PhD, 1 Carolyn A. Saunders, BA, 2 Maobing Tu, PhD, 3 Kathrin Stoll, MA, 2 Jonathan Berkowitz, PhD, 4 for the Early External Cephalic Version Trial Collaborators Group* 1 Department of Obstetrics and Gynecology, McMaster University, Hamilton ON 2 Division of Midwifery, Department of Family Practice, Faculty of Medicine, University of British Columbia, Vancouver BC 3 Department of Wood Sciences, University of British Columbia, Vancouver BC 4 Department of Family Practice, University of British Columbia, Vancouver BC *The members of the Early External Cephalic Version Trial Group are listed in the Appendix. Abstract Objectives: The objective of this research was to determine factors that were associated with a successful external cephalic version (ECV) procedure. Methods: We undertook a secondary analysis of data from a randomized controlled trial, The Early External Cephalic Version (Pilot) Trial. In this secondary analysis, we included data for the subset of 178 women who had an ECV as part of the pilot trial (123 nulliparous women with any breech presentation and 55 multiparous women with a frank breech presentation only). Using this dataset, we began with two separate univariate analyses, one of characteristics that could be determined before undertaking a procedure, and the other of factors associated with the ECV procedure itself. Variables that had a P value of 0.1 in the univariate analyses were included in two separate logistic regression models, one for preprocedural and one for procedural factors, using a backward elimination approach. Results: Multiparity and a non-engaged presenting part were significant preprocedural predictors of ECV success. Procedural factors predictive of ECV success included lower reported maternal pain scores during the procedure, a single attempt at ECV, and a more mobile fetus. Conclusion: Non-engagement of the presenting part was the only modifiable factor predicting ECV success that was identified in this analysis, and it supports the hypothesis that beginning the ECV procedure earlier in pregnancy, prior to engagement, may have merit. The Early ECV 2 Trial is in progress and will further test this hypothesis. Résumé Objectifs : Cette recherche avait pour but de déterminer les facteurs qui étaient associés à la réussite d une intervention de version céphalique par manœuvres externes (VCE). Méthodes : Nous avons entrepris une analyse secondaire des données issues d un essai comparatif randomisé, soit l essai The Early External Cephalic Version (Pilot) Trial. Pour cette analyse secondaire, nous avons inclus les données du sous-ensemble de 178 femmes qui avaient subi une VCE dans le cadre de l essai pilote (123 femmes nullipares connaissant une présentation du siège [quelle qu elle soit] et 55 femmes multipares connaissant une présentation du siège décomplété seulement). Au moyen de cet ensemble de données, nous avons procédé à deux analyses univariées distinctes : l une d entre elles portant sur les caractéristiques qui pourraient être recherchées avant la tenue de l intervention et l autre, sur les facteurs associés à l intervention de VCE elle-même. Les variables qui détenaient une valeur P 0,1 dans le cadre des analyses univariées ont été incluses dans deux modèles de régression logistique distincts (l un d entre eux portant sur les facteurs préinterventions et l autre, sur les facteurs associés à l intervention), au moyen d une approche d élimination régressive. Résultats : La multiparité et une présentation non engagée constituaient des prédicteurs préinterventions significatifs de la réussite de la VCE. Parmi les facteurs associés à l intervention qui permettaient de prédire la réussite de la VCE, on trouvait le signalement de scores de douleur maternelle moindres au cours de l intervention, le fait de ne procéder qu à une seule tentative de VCE et la présence d un fœtus plus mobile. Key Words: Breech, external cephalic version, Caesarean section, predictors of success Competing Interests: None declared. Received on May 24, 2007 Accepted on September 26, 2007 Conclusion : Le non engagement de la présentation constituait le seul facteur modifiable pouvant prédire la réussite de la VCE que cette analyse a permis d identifier; ce qui soutient l hypothèse selon laquelle il pourrait s avérer indiqué de débuter l intervention de VCE plus tôt (avant l engagement) au cours de la grossesse. L essai Early ECV 2 Trial est en cours et contribuera à déterminer la validité de cette hypothèse. J Obstet Gynaecol Can 2008;30(1):23 28 JANUARY JOGC JANVIER

17 OBSTETRICS INTRODUCTION External cephalic version effectively reduces the rates of breech presentation and Caesarean section in women with a fetus presenting as a breech at term; however, rates of success are relatively low. 1 3 In order to determine if there were any factors that could be used to predict success of the ECV procedure in our trial population, we performed a secondary analysis on data from a randomized controlled trial. The pilot study, conducted between July 1999 and February 2002, compared early and delayed ECV. 1 It included only women who were most likely to benefit from beginning the procedure early; that is, those who were nulliparous (65%) with any breech presentation or who were multiparous with a frank breech presentation and parity < It was considered that multiparous women with other than frank breech presentations were most likely to experience spontaneous version prior to 37 weeks, and they were thus less likely to benefit from the pilot trial intervention. For the 116 women randomized to the early ECV group, the first ECV procedure was planned for between 34 weeks 0 days and 36 weeks 0 days of gestation. For the 116 women randomized to the delayed ECV group, the first ECV procedure was planned for between 37 weeks 0 days and 38 weeks 0 days. 1 Eighty-six percent of women (n = 100) randomized to the early ECV group and 67% of women (n = 78) in the delayed ECV group had had at least one ECV procedure. Of the 178 women who had an ECV as part of the pilot trial, 54 (30.3%) had a successful procedure. Forty-one of the 54 women with successful ECVs (76%) went on to have a cephalic vaginal delivery. MATERIAL AND METHODS Data for this secondary analysis were collected as part of the Early External Cephalic Version Pilot Trial, approved by the Office of Research Services at the University of Toronto on September 11, Approval from the clinical research ethics boards of each participating centre was obtained prior to the recruitment of women into the pilot trial. The data collected were related to potential predictors of success, using the existing literature as a guide to which variables might be important. Additional details about the AFI CI ECV MVP OR ABBREVIATIONS amniotic fluid index confidence interval external cephalic version maximum vertical pocket odds ratio data collection and methodology used in the EECV Pilot Trial are provided in the published report. 1 For the secondary analysis of predictors of ECV success, we felt that it was clinically important to consider factors that could be determined prior to the procedure (preprocedural factors) separately from factors that could only be determined as part of the ECV procedure itself (procedural factors). The secondary analysis included 11 preprocedural factors: fundal height, body mass index at the time of randomization, amniotic fluid index at the time of randomization, previous breech birth, parity, placental location, type of breech, fetal position, the condition of abdominal wall musculature, abdominal obesity, and the station of the presenting part at the time of the procedure. The analysis included seven procedural factors: maternal pain experienced during the ECV procedure, number of attempts at ECV, use of tocolytic, uterine tone during the procedure, palpability of the fetal head during the procedure, mobility of the fetus during the procedure as determined by palpation, and gestational age at the time of the procedure. Station was assessed clinically as floating, dipping, or well into pelvis or engaged. Maternal pain was quantified using a visual analogue scale with the endpoints of pain free/ total comfort and most extreme pain imaginable. Uterine tone, palpability of the fetal head, and mobility of the fetus were all assessed clinically by the practitioner at the time of the procedure. Data were analyzed, using the SPSS version 12 (SPSS Inc., Chicago IL). We began by using univariate analyses to find associations between each of the preprocedural and procedural factors and the success of the woman s first ECV procedure. We used the Student t test for continuous data and the chi-square test for categorical data. In order to determine possible predictors of ECV success in this study population, those variables with a P value of 0.1 were then included in one of two separate logistic regression models, one including preprocedural factors and the other including procedural factors. Factors were entered using a Wald backward elimination approach. RESULTS The results of the univariate analyses are shown in Table 1. Four preprocedural factors were identified as being associated at a significance level of P 0.1 with ECV outcome (0 = ECV failed; 1= ECV succeeded). Nulliparity, muscular abdominal wall, obese abdomen, and engaged presenting part were all associated with failed ECV. Five procedural factors were found to be associated with the success or failure of the ECV procedure. Higher levels of pain with the ECV procedure and increased numbers of 24 JANUARY JOGC JANVIER 2008

18 Factors Associated With a Successful External Cephalic Version in the Early ECV Trial Table 1. Preprocedural and procedural variables associated with ECV outcome Predictor Successful ECV (n = 54) Preprocedural factors Failed ECV (n = 124) P Mean fundal height in cm (SD) 34.8 (2.1) 34.4 (1.4) Mean body mass index (SD) 27.4 (4.8) 27.5 (3.9) n (%) n (%) Previous breech Yes No 4 (7.4) 50 (92.6) 4 (3.2) 120 (96.8) Parity Nulliparous Multiparous 28 (51.9) 26 (48.1) 95 (76.6) 29 (23.4) Amniotic fluid assessment* Low Moderate High 8 (22.2) 13 (36.1) 15 (41.7) 32 (36.0) 35 (39.3) 22 (24.7) Placental location Anterior or fundal Posterior or lateral 23 (45.1) 28 (54.9) 63 (52.5) 57 (47.5) Type of breech Frank breech Non-frank breech 44 (81.5) 10 (18.5) 93 (75.6) 30 (24.4) Fetal position Sacrum posterior Sacrum anterior or transverse 3 (6.1) 46 (93.9) 16 (14.3) 96 (85.7) Abdominal wall musculature Muscular Lax or unremarkable 6 (11.1) 48 (88.9) 30 (24.2) 94 (75.8) Abdominal obesity Obese Thin or unremarkable 9 (16.7) 45 (83.3) 10 (8.1) 114 (91.9) Station of the presenting part Engaged Floating or dipping 4 (7.4) 50 (92.6) 42 (34.1) 81 (65.9) Procedural factors Mean maternal pain score with ECV (SD) 32.4 (23.5) 49.1 (23.7) n (%) n (%) Number of attempts at version 2 or more attempts 1 attempt Use of tocolytic Yes No Uterine tone during procedure Contractile Relaxed throughout Palpability of fetal head Difficult Easy or unremarkable Mobility of the fetus during procedure Not very mobile Very or moderately mobile Timing of the procedure 37 weeks gestation 37 weeks gestation 20 (37.0) 34 (63.0) 30 (55.6) 24 (44.4) 10 (18.5) 44 (81.5) 3 (5.6) 51 (94.4) 10 (18.5) 44 (81.5) 17 (31.5) 37 (68.5) 102 (82.3) 22 (17.7) 65 (52.4) 59 (47.6) 43 (34.7) 81 (65.3) 18 (14.5) 106 (85.5) 90 (72.6) 34 (27.4) 53 (42.7) 71 (57.3) *54 women were missing data for the amniotic fluid assessment: 19 with a successful procedure and 35 with a failed procedure. A high AFI was defined as >14.5 cm or an MVP > 6 cm, medium AFI was cm or MVP 4 6 cm, and low AFI was <4cmor MVP < 4 cm. 7 women had an unknown placental location: 3 with a successful procedure and 4 with a failed procedure. one woman had an unknown type of breech and had a failed procedure. 17 women had an unknown fetal position: 5 with a successful procedure and 12 with a failed procedure. one woman had an unknown station of the presenting part and had a failed procedure JANUARY JOGC JANVIER

19 OBSTETRICS Table 2. Logistic regression analyses with ECV outcome as dependent variable and preprocedural characteristics as predictors (N = 178) (All three steps involved in the backward elimination approach are shown, and reference categories for each variable are listed in parentheses.) Predictor Beta P OR 95% CI R 2 Step * Parity (Multiparity) , 5.80 Abdominal Wall Musculature , 5.06 (Lax or unremarkable) Abdominal Obesity , 1.75 (Thin or unremarkable) Station of Presenting Part ,19.94 (Floating or dipping) Step * Parity (Multiparity) , 5.94 Abdominal Wall Musculature , 5.35 (Lax or unremarkable) Station of Presenting Part , (Floating or dipping) Step * Parity (Multiparity) , 6.61 Station of Presenting Part , (Floating or dipping) R 2 : Nagelkerke R Square *significance level of each model attempts at the ECV procedure were associated with failure; having a very or moderately mobile fetus, relaxed uterine tone, and a fetal head that was unremarkable or easy to palpate were associated with ECV success. When we entered the four preprocedural factors into the logistic regression model, the best predictive model (step 3) found that multiparity (OR 3.23; 95% CI ) and non-engaged station of the presenting part (OR 6.63; 95% CI ) emerged as significant preprocedural predictors of ECV success. All steps of the logistic regression model for preprocedural factors are shown in Table 2. When we entered the five procedural factors into a logistic regression model, we found that increased mobility of the fetus at the time of the procedure (OR 8.35; 95% CI ), less pain experienced during the procedure (P = 0.03), and fewer attempts to perform ECV (OR 4.2; 95% CI ) were significant procedural predictors of ECV success (see Table 3, step 3). DISCUSSION In this study of women with breech presentation, we found that multiparous women and women with a non-engaged presenting part were more likely to have a successful external cephalic version. Women who had more than one attempt at ECV, who experienced more pain during the procedure, or who had a fetus that was not very mobile during the procedure were significantly less likely to have a successful ECV procedure. Multiparity has been identified in several prior studies as an important predictor of ECV success. 4,8,9,12,15 Even though this study included only those multiparous women who were least likely to have a successful ECV (i.e., those with frank breech presentations), parity still emerged as a significant predictor of ECV outcome. Non-engagement of the fetal presenting part was associated with ECV success in five of six prior studies that included this variable. 6,10,12,14,16 It is possible that starting ECV earlier in pregnancy, before engagement of the fetus, might improve the likelihood of success. The Early ECV 2 Trial, 18 currently in progress, will test the hypothesis that beginning ECV earlier in pregnancy (thus decreasing the likelihood of engagement) will result in fewer Caesarean sections. Although vaginal elevation of the presenting part was not recommended as part of our study protocol, and although it remains an untested method of facilitating ECV, it has been used in other studies, 19,20 and may be useful for enhancing success with ECV when the breech is engaged. 26 JANUARY JOGC JANVIER 2008

20 Factors Associated With a Successful External Cephalic Version in the Early ECV Trial Table 3. Logistic regression analyses with ECV outcome as dependent variable and procedural factors as predictors (N = 178) (All three steps involved in the backward elimination approach are shown, and reference categories for each variable are listed in parentheses.) Predictor Beta P OR 95% CI R 2 Step * Pain with ECV (continuous variable with higher scores indicating more pain ) Mobility of fetus during the procedure (moderately or very mobile) Number of ECV attempts (one attempt) Ease of palpating fetal head (easy or unremarkable) Uterine tone during procedure (relaxed) Step * Pain with ECV (continuous variable with higher scores indicating more pain ) Mobility of fetus during the procedure (moderately or very mobile) Number of ECV attempts (one attempt) Uterine tone during procedure (relaxed) Step * Pain with ECV (continuous variable with higher scores indicating more pain ) Mobility of fetus during the procedure (moderately or very mobile) Number of ECV attempts (one attempt) R 2 : Nagelkerke R Square *significance level of each model Our finding that ECV is more likely to fail when women report higher pain scores associated with the procedure is consistent with earlier findings by a research team in Hong Kong. 21 This finding may be because more vigorous (and thus more painful) attempts at ECV are made when a fetus is not turning readily, or because when pain is reported, the ECV attempt is abandoned. In the pilot study, the ECV procedure was stopped prematurely in 24 women; in 14 of these, the procedure was stopped because of maternal discomfort. 1 Of note, tocolytics were not found to be associated with ECV success in this study. However, tocolytics were used only 47% of the time, and it is possible that in centres where tocolytics were not used routinely they may have been used only when the ECV was expected to be more difficult. The findings of this secondary analysis may have limited generalizability because the sample included women who had an ECV procedure as early as 34 weeks gestation; however, we believe the findings are important in helping to estimate the likely success of the procedure. The study s unique feature is its separate consideration of preprocedural and procedural prognostic factors. CONCLUSION Non-engagement of the presenting part was the only modifiable factor that was associated with success of ECV in the management of breech presentation. This finding is consistent with the hypothesis that beginning the ECV procedure earlier in pregnancy, just prior to engagement, may have merit. A study is underway to test this hypothesis. ACKNOWLEDGEMENTS The Early External Cephalic Version Trial was supported by Canadian Institutes of Health Research (CIHR) grant No. MT E. K. Hutton is supported by a CIHR Research New Investigator Award and a Michael Smith Foundation for Health Research Scholar Award. JANUARY JOGC JANVIER