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The Early External Cephalic Version (ECV) 2 Trial: an international multicentre randomised controlled trial of timing of ECV for breech pregnancies

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Abstract:

Please cite this paper as: Hutton E, Hannah M, Ross S, Delisle M, Carson G, Windrim R, Ohlsson A, Willan A, Gafni A, Sylvestre G, Natale R, Barrett Y, Pollard J, Dunn M, Turtle P, for the Early ECV2 Trial Collaborative Group. The Early External Cephalic Version (ECV) 2 Trial: an international multicentre randomised controlled trial of timing of ECV for breech pregnancies. BJOG 2011;118:564–577. Objective 

To investigate whether initiating external cephalic version (ECV) earlier in pregnancy might increase the rate of successful ECV procedures, and be more effective in decreasing the rate of non-cephalic presentation at birth and of caesarean section. Design 

An unblinded multicentred randomised controlled trial. Setting 

A total of 1543 women were randomised from 68 centres in 21 countries. Population 

Women with a singleton breech fetus at a gestational age of 330/7 weeks (231 days) to 356/7 weeks (251 days) of gestation were included. Methods 

Participants were randomly assigned to having a first ECV procedure between the gestational ages of 340/7 (238 days) and 356/7 weeks of gestation (early ECV group) or at or after 370/7 (259 days) weeks of gestation (delayed ECV group). Main outcome measures 

The primary outcome was the rate of caesarean section; the secondary outcome was the rate of preterm birth. Results 

Fewer fetuses were in a non-cephalic presentation at birth in the early ECV group (314/765 [41.1%] versus 377/768 [49.1%] in the delayed ECV group; relative risk [RR] 0.84, 95% CI 0.75, 0.94, P = 0.002). There were no differences in rates of caesarean section (398/765 [52.0%] versus 430/768 [56.0%]; RR 0.93, 95% CI 0.85, 1.02, P = 0.12) or in risk of preterm birth (50/765 [6.5%] versus 34/768 [4.4%]; RR 1.48, 95% CI 0.97, 2.26, P = 0.07) between groups. Conclusion 

External cephalic version at 34–35 weeks versus 37 or more weeks of gestation increases the likelihood of cephalic presentation at birth but does not reduce the rate of caesarean section and may increase the rate of preterm birth.

Keywords: Breech pregnancy; caesarean section; external cephalic version; fetal version; randomised controlled trial

Document Type: Research Article

DOI: http://dx.doi.org/10.1111/j.1471-0528.2010.02837.x

Affiliations: 1: Department of Obstetrics and Gynecology (Midwifery), McMaster University Faculty of Health Sciences, Hamilton, ON 2: Department of Obstetrics and Gynaecology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON 3: Department of Obstetrics and Gynaecology, University of Calgary, Calgary, AB 4: Department of Obstetrics and Gynaecology, BC Women’s Hospital, University of British Columbia, Vancouver, BC 5: Department of Obstetrics and Gynecology, Regina Qu’Appelle Health Region, Regina, SK 6: Mount Sinai Hospital, Departments of Obstetrics and Gynaecology and Health Policy, Management and Evaluation, University of Toronto, Toronto, ON 7: Mount Sinai Hospital, Departments of Paediatrics, Obstetrics and Gynaecology and Health Policy, Management and Evaluation 8: Program in Child Health Evaluative Sciences, Sick Kids Research Institute, Department of Public Health Sciences, University of Toronto, Toronto, ON 9: Centre for Health Economics and Policy Analysis, Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada 10: Weill Cornell Medical College, New York City, NY, USA 11: Department of Obstetrics and Gynecology and Pediatrics, Schulich School of Medicine, University of Western Ontario, London, ON, Canada 12: Department of Newborn and Developmental Paediatrics, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada 13: EECV2 Trial Consumer Representative, Toronto, ON Canada

Publication date: April 1, 2011

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