Maternal outcomes at 2 years after planned cesarean section versus planned vaginal birth for breech presentation at term: The international randomized Term Breech Trial Mary E. Hannah, MDCM,a,d,e Hilary Whyte, MD,b,d Walter J. Hannah, MD,a Sheila Hewson, BA,e Kofi Amankwah, MD,a Mary Cheng, MD,g Amiram Gafni, PhD,e,h Patricia Guselle, BA,e Michael Helewa, MD,j Ellen D. Hodnett, RN, PhD,f Eileen Hutton, PhD,a Rose Kung, MD,a Darren McKay, BCS,e Susan Ross, PhD,a,d,e Saroj Saigal, MD,i Andrew Willan, PhD,c,e for the 2-year maternal follow-up Term Breech Trial Collaborative Group* Departments of Obstetrics and Gynaecology, Sunnybrook and Women���s College Health Sciences Centre,a Paediatrics, Hospital for Sick Children,b Public Health Sciences,c Health Policy Management and Evaluation,d Maternal Infant and Reproductive Health Research Unit at the Centre for Research in Women���s Health,e Faculty of Nursing,f University of Toronto, Toronto, Ontario, Canada, Department of Obstetrics and Gynaecology, Centenary Hospital,g Scarborough, Ontario, Canada, Department of Clinical Epidemiology and Biostatisticsh and Paediatrics,i McMaster University Hamilton, Ontario, Canada, and Department of Obstetrics and Gynaecology, St Boniface Hospital, University of Manitoba,j Winnipeg, Manitoba, Canada KEY WORDS Random allocation Cesarean section Childbirth Pain Incontinence Sexual problems Depression Pregnancy Health problems Satisfaction Objective: This study was undertaken to compare maternal outcomes at 2 years postpartum after planned cesarean section and planned vaginal birth for the singleton fetus in breech presentation at term. Study design: In selected centers in the Term Breech Trial, mothers completed a structured questionnaire at 2 or more years postpartum to determine their health in the previous 3 to 6 months. Results: A total of 917 of 1159 (79.1%) mothers from 85 centers completed a follow-up questionnaire at 2 years postpartum. There were no differences between groups in breast feeding, relationship with child or partner, pain, subsequent pregnancy, incontinence, depression, urinary, menstrual or sexual problems, fatigue, or distressing memories of the birth experience. Planned cesarean section was associated with a higher risk of constipation (P = .02). * Members listed at end of article. Supported by a grant from the Canadian Institutes of Health Research (CIHR) (grant number: MT-37415). Dr Hannah holds a CIHR Senior Scientist Award. The Data Co-ordination Centre was supported by grants from the Centre for Research in Women���s Health, Sunnybrook and Women���s College Health Sciences Centre, and the Department of Obstetrics and Gynaecology at the University of Toronto, Toronto, Ontario, Canada. Presented at the Twenty-fourth Annual Meeting of the Society for Maternal Fetal Medicine, New Orleans, La, February 2-7, 2004. Reprints are not available from the authors. 0002-9378/$ - see front matter �� 2004 Elsevier Inc. All rights reserved. doi:10.1016/j.ajog.2004.08.004 American Journal of Obstetrics and Gynecology (2004) 191, 917e27 www.elsevier.com/locate/ajog

Conclusion: Maternal outcomes at 2 years postpartum are similar after planned cesarean section and planned vaginal birth for the singleton breech fetus at term. �� 2004 Elsevier Inc. All rights reserved. Most pregnant women at term are encouraged to undergo a trial of labor in anticipation of a vaginal birth, as the risks for the woman are generally lower with a vaginal delivery than if delivery is by cesarean section.1,2 However, if the fetus is in a breech pre- sentation a planned cesarean section is usually recom- mended.3 The Term Breech Trial, a multicenter international randomized controlled trial of 2088 women, found no increased risk of maternal mortality or serious maternal morbidity during the first 6 weeks postpartum after planned cesarean section versus planned vaginal birth for the singleton breech fetus at term (3.9% vs 3.2%, P = .35), and at 3 months postpartum, women in the planned cesarean section group were less likely to report urinary incontinence.3,4 To date, no randomized study of planned method of delivery has followed mothers beyond the early postpartum period. The Term Breech Trial, which avoided selection bias because of random- ization, provided a unique opportunity to assess the effects of planned method of delivery on maternal outcomes 2 years after the birth. Materials and methods Eligibility and randomization Women were eligible for the trial if they had a singleton live fetus in a frank or complete breech presentation at term (R37 weeks��� gestation). Women were excluded if there was evidence of fetopelvic disproportion, if the fetus was judged to be clinically large or to weigh 4000g or more, if there was hyperextension of the fetal head, if there was a lethal anomaly or a condition that might cause a mechanical problem at delivery, or if there was a contraindication to labor or vaginal delivery. The study was approved by the research ethics committees at participating centers and women gave informed consent before being enrolled in the study. Eligible and consent- ing women were then randomly allocated, using a cen- tralized randomization service, to the planned cesarean section or vaginal birth groups. Infants in breech pre- sentation, who were delivered vaginally, were attended by a clinician experienced in vaginal breech delivery. The details of the eligibility criteria and treatment protocol have been published previously.3 Centers that were confident in their ability to trace more than 80% of randomized women, monitored the women to 2 or more years postpartum. Follow-up and outcomes Mothers completed a structured questionnaire at 2 years postpartum to determine duration of breast feeding, relationship with the infant and husband/partner, and the existence of health problems, during the previous 3 to 6 months. For every health problem, women indicated how much of a problem this had been for them, that is, no problem at all, a little problem, or a big problem. Depression was defined as a score greater than 12 on the Edinburgh Postnatal Depression Scale (EPDS)5 that was revised to ask women how they had felt in the previous 3 to 6 months, rather than within the previous 7 days. Aside from the EPDS, all questions were formulated after a review of the literature and discussions among members of the Steering Committee, and the question- naire was pretested before use. The questionnaires were either translated (and back translated to ensure accuracy of the translation) into the mother���s language or were administered by someone who could translate the questions for the woman. We used previously published translations of the EPDS when available.6 Statistical analysis The results were analyzed according to intention to treat as we wished to determine the effect of the approach to delivery rather than the effect of the actual method of delivery. All women who delivered at centers participat- ing in the follow-up, for whom we had completed questionnaires, were included in the analysis. Partici- pating centers were categorized according to whether they were in a country with a low (%20/1000) or high (20/1000) national perinatal mortality rate as defined by the World Health Organization in 1996.7 Countries with low national perinatal mortality rates were Aus- tralia, Canada, Chile, Denmark, Germany, Israel, The Netherlands, New Zealand, Poland, Portugal, Romania, Switzerland, the United Kingdom, and the United States. Countries with high national perinatal mortality rates were Argentina, Brazil, Jordan, and Pakistan. The randomized groups were compared with the use of Fisher exact test for the analysis of binary outcomes, Wilcoxon���s rank sum test for the analysis of continuous variables that were not normally distributed, and the generalized Fisher exact test or the c2 test for linear trend for the analysis of ordered categorical outcomes. A 2-sided P-value of less than .05 indicated statistical significance. Relative risks and 95% CIs were also calculated. The analyses were undertaken using SAS System version 8.0 (SAS Institute Inc, Cary, NC). The 918 Hannah et al