External cephalic version for breech presentation at term (Review) Hofmeyr GJ, Kulier R, West HM This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2015, Issue 4 http://www.thecochranelibrary.com External cephalic version for breech presentation at term (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. TABLE OF CONTENTS HEADER....................................... 1 ABSTRACT ...................................... 1 PLAINLANGUAGESUMMARY . 2 SUMMARY OF FINDINGS FOR THE MAIN COMPARISON . ..... 3 BACKGROUND .................................... 6 OBJECTIVES ..................................... 8 METHODS ...................................... 8 RESULTS....................................... 11 Figure1. ..................................... 13 Figure2. ..................................... 14 DISCUSSION ..................................... 16 AUTHORS’CONCLUSIONS . 17 ACKNOWLEDGEMENTS . 17 REFERENCES ..................................... 18 CHARACTERISTICSOFSTUDIES . 22 DATAANDANALYSES. 34 Analysis 1.1. Comparison 1 External cephalic version at term versus no ECV attempt, Outcome 1 Vaginal cephalic birth not achieved (CS + breech vaginal birth) (not prespecified). ............ 35 Analysis 1.2. Comparison 1 External cephalic version at term versus no ECV attempt, Outcome 2 Caesarean section. 36 Analysis 1.3. Comparison 1 External cephalic version at term versus no ECV attempt, Outcome 3 Non-cephalic presentationatbirth. 37 Analysis 1.4. Comparison 1 External cephalic version at term versus no ECV attempt, Outcome 4 Vaginal breech birth (notprespecified). ................................ 38 Analysis 1.5. Comparison 1 External cephalic version at term versus no ECV attempt, Outcome 5 Apgar score < 7 at 1 minute(notprespecified). 39 Analysis 1.6. Comparison 1 External cephalic version at term versus no ECV attempt, Outcome 6 Apgar score < 7 at 5 minutes. ................................... 40 Analysis 1.7. Comparison 1 External cephalic version at term versus no ECV attempt, Outcome 7 Umbilical vein pH < 7.20...................................... 41 Analysis 1.8. Comparison 1 External cephalic version at term versus no ECV attempt, Outcome 8 Perinatal death. 42 Analysis 1.9. Comparison 1 External cephalic version at term versus no ECV attempt, Outcome 9 Neonatal admission. 43 Analysis 1.10. Comparison 1 External cephalic version at term versus no ECV attempt, Outcome 10 Enrolment-delivery interval(notprespecified). 44 Analysis 2.1. Comparison 2 Sensitivity analysis (excluding studies with high risk of bias), Outcome 1 Vaginal cephalic birth not achieved (CS + breech vaginal birth). 45 Analysis 2.2. Comparison 2 Sensitivity analysis (excluding studies with high risk of bias), Outcome 2 Caesarean section. 46 Analysis 2.3. Comparison 2 Sensitivity analysis (excluding studies with high risk of bias), Outcome 3 Non cephalic presentationatbirth. 47 Analysis 2.4. Comparison 2 Sensitivity analysis (excluding studies with high risk of bias), Outcome 4 Vaginal breech birth...................................... 48 Analysis 3.1. Comparison 3 Sensitivity analysis (excluding studies in Africa), Outcome 1 Vaginal cephalic birth not achieved (CS+breechvaginalbirth). 49 Analysis 3.2. Comparison 3 Sensitivity analysis (excluding studies in Africa), Outcome 2 Caesarean section. 50 Analysis 3.3. Comparison 3 Sensitivity analysis (excluding studies in Africa), Outcome 3 Non cephalic presentation at birth...................................... 51 Analysis 3.4. Comparison 3 Sensitivity analysis (excluding studies in Africa), Outcome 4 Vaginal breech birth. 52 APPENDICES ..................................... 52 WHAT’SNEW..................................... 52 HISTORY....................................... 53 CONTRIBUTIONSOFAUTHORS . 53 DECLARATIONSOFINTEREST . 54 External cephalic version for breech presentation at term (Review) i Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. SOURCESOFSUPPORT . 54 DIFFERENCES BETWEEN PROTOCOL AND REVIEW . .... 54 INDEXTERMS .................................... 54 External cephalic version for breech presentation at term (Review) ii Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. [Intervention Review] External cephalic version for breech presentation at term G Justus Hofmeyr1, Regina Kulier2, Helen M West3 1Department of Obstetrics and Gynaecology, East London Hospital Complex, University of the Witwatersrand, University of Fort Hare, Eastern Cape Department of Health, East London, South Africa. 2Geneva, Switzerland. 3Cochrane Pregnancy and Childbirth Group, Department of Women’s and Children’s Health, The University of Liverpool, Liverpool, UK Contact address: G Justus Hofmeyr, Department of Obstetrics and Gynaecology, East London Hospital Complex, University of the Witwatersrand, University of Fort Hare, Eastern Cape Department of Health, Frere and Cecilia Makiwane Hospitals, Private Bag X 9047, East London, Eastern Cape, 5200, South Africa. [email protected]. Editorial group: Cochrane Pregnancy and Childbirth Group. Publication status and date: New search for studies and content updated (no change to conclusions), published in Issue 4, 2015. Review content assessed as up-to-date: 28 February 2015. Citation: Hofmeyr GJ, Kulier R, West HM. External cephalic version for breech presentation at term. Cochrane Database of Systematic Reviews 2015, Issue 4. Art. No.: CD000083. DOI: 10.1002/14651858.CD000083.pub3. Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. ABSTRACT Background Management of breech presentation is controversial, particularly in regard to manipulation of the position of the fetus by external cephalic version (ECV). ECV may reduce the number of breech presentations and caesarean sections, but there also have been reports of complications with the procedure. Objectives The objective of this review was to assess the effects of ECV at or near term on measures of pregnancy outcome. Methods of facilitating ECV, and ECV before term are reviewed separately. Search methods We searched the Cochrane Pregnancy and Childbirth Trials Register (28 February 2015) and reference lists of retrieved studies. Selection criteria Randomised trials of ECV at or near term (with or without tocolysis) compared with no attempt at ECV in women with breech presentation. Data collection and analysis Two review authors assessed eligibility and trial quality, and extracted the data. Main results We included eight studies, with a total of 1308 women randomised. The pooled data from these studies show a statistically significant and clinically meaningful reduction in non-cephalic presentation at birth (average risk ratio (RR) 0.42, 95% confidence interval (CI) 0.29 to 0.61, eight trials, 1305 women); vaginal cephalic birth not achieved (average RR 0.46, 95% CI 0.33 to 0.62, seven trials, 1253 women, evidence graded very low); and caesarean section (average RR 0.57, 95% CI 0.40 to 0.82, eight trials, 1305 women, evidence graded very low) when ECV was attempted in comparison to no ECV attempted. There were no significant differences in the incidence of Apgar score ratings below seven at one minute (average RR 0.67, 95% CI 0.32 to 1.37, three trials, 168 infants) or five minutes (RR 0.63, 95% CI 0.29 to 1.36, five trials, 428 infants, evidence graded very low), low umbilical vein pH levels (RR 0.65, 95% CI 0.17 External cephalic version for breech presentation at term (Review) 1 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. to 2.44, one trial, 52 infants, evidence graded very low), neonatal admission (RR 0.80, 95% CI 0.48 to 1.34, four trials, 368 infants, evidence graded very low), perinatal death (RR 0.39, 95% CI 0.09 to 1.64, eight trials, 1305 infants, evidence graded low), nor time from enrolment to delivery (mean difference -0.25 days, 95% CI -2.81 to 2.31, two trials, 256 women). All of the trials included in this review had design limitations, and the level of evidence was graded low or very low. No studies attempted to blind the intervention, and the process of random allocation was suboptimal in several studies. Three of the eight trials had serious design limitations, however excluding these studies in a sensitivity analysis for outcomes with substantial heterogeneity did not alter the results. Authors’ conclusions Attempting cephalic version at term reduces the chance of non-cephalic presentation at birth, vaginal cephalic birth not achieved and caesarean section. There is not enough evidence from randomised trials to assess complications of ECV at term. Large observational studies suggest that complications are rare. PLAIN LANGUAGE SUMMARY External cephalic version for breech presentation at term External cephalic version (ECV) from 36 weeks reduces the chance of breech presentation at birth and caesarean section. There is less risk to the baby and mother when the baby is head-down at the time of birth. ECV is a procedure by which the baby, who is lying bottom first, is manipulated through the mother’s abdominal wall to the head-down position. The review of eight studies, involving 1308 women, found that If the baby is not head down after about 36 weeks of pregnancy, ECV reduces the chance that the baby will present as breech at the time of birth, reduces the chance of caesarean birth, and increases the chance that a head-first vaginal delivery will be achieved External cephalic version