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A retrospective study of the success, safety and effectiveness of external cephalic version without tocolysis in a specialised midwifery centre in the Netherlands

A retrospective study of the success, safety and effectiveness of external cephalic version without tocolysis in a specialised midwifery centre in the Netherlands
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  Midwifery (2008)  24 , 38 – 45 A retrospective study of the success, safety andeffectiveness of external cephalic version without tocolysisin a specialised midwifery centre in the Netherlands Marlies Rijnders, BSc, RM a,  , Kathy Herschderfer, RM a , Marianne Prins, BEd, RM b , Riet van Baaren, RM c ,Anne-Johan van Veelen, PhD, MD c , Yvonne Scho¨nbeck, MSc a , Simone Buitendijk, PhD, MD(Perinatal Epidemiologist) a a TNO Quality of Life, Prevention and Physical Activity, Child Health Division, P.O. Box 2215, 2301 CE Leiden, The Netherlands  b Midwifery School, Amsterdam, The Netherlands  c Slotervaart Hospital, Amsterdam, The Netherlands   Corresponding author.  E-mail address:  marlies.rijnders@tno.nl (M. Rijnders). Received 18 November 2005; received in revised form 5 July 2006; accepted 17 July 2006 Abstract Background:  to evaluate the effectiveness of external cephalic version (ECV) without tocolysis or epidural analgesia,the complications associated with the procedure and the association between the number of ECVattempts and cephalicpresentation at birth and caesarean section. Methods:  retrospective cohort study of all ( n ¼ 924) ECVs carried out between 1996 and 2000 in a specialisedmidwifery centre in the Netherlands. After bivariate analysis, those variables with a  p  value under 0.05 wereconsidered statistically significant and were tested in a logistic regression model using backward stepwise selection.Analyses were carried out separately for first ECV attempts and second ECV attempts. Findings:  in total, 958 ECVs were analysed, 889 first attempts and 69 repeat attempts. Seventy per cent of all first ECVswere carried out before 37 weeks, but half of those were carried out between 36 and 37 weeks. The success rate forfirst ECV was 41% and for the second ECV 29%. Bivariate analysis showed that the success of the first ECV was positivelyinfluenced by parity, non-Dutch srcin, higher birth weight, higher age and longer duration of pregnancy. After logisticregression, parity (odds ratio [OR] 2.8, 95% CI 2.1 to 3.7), non-Dutch srcin (OR 1.8, 95% CI 1.2 to 2.8) and birth weight(OR 1.7, 95% CI 1.4 to 2.0) remained factors that independently influenced the success of ECV. The odds ratio forduration of pregnancy at first ECV was borderline significant: OR 1.2 (1.0 to 1.4). After an unsuccessful first ECV, only13% of the women received a second ECV. The prevalence of cephalic presentation at birth increased with 3% after asecond ECV. Three cases of complications were reported during or very shortly after the first ECV, and these did notresult in serious complications. No complications were reported after a second ECV. Conclusion:  ECV without tocolysis is a safe procedure for pregnant women and their babies. Repeat ECV increases thenumber of cephalic presentations at birth and should be considered after an unsuccessful ECV. &  2006 Elsevier Ltd. All rights reserved. Keywords  Cephalic version; Success; Safety; Breech ECV; External cephalic version ARTICLE IN PRESS www.elsevier.com/locate/midw0266-6138/$-see front matter  &  2006 Elsevier Ltd. All rights reserved.doi:10.1016/j.midw.2006.07.009  Introduction The obstetricl system in the Netherlands is uniquein its focus on physiological childbirth. Historically,vaginal breech birth has always been considered areasonable and safe option.This policy resulted in a relatively low number of caesarean sections for breech presentation in theNetherlands compared with other Western coun-tries (Leeuw, 1999). However, the number of caesarean sections for breech presentation beganslowly to increase in the second half of the 1990s,from 42% in 1996 to 50% in 2000 (Rietberg, 2003).After the publication of the Term Breech Trial atthe end of 2000 (Hannah, 2000), the percentage of caesarean sections for breech presentation in-creased substantially to 80%. The primary caesar-ean section rate for breech presentation doubledduring the same period from 30 – 60% (Roumen,2002). The choice for caesarean section in case of breech presentation is rapidly becoming standardpolicy in the Netherlands, and is used as a means of preventing the neonatal mortality and morbidityshown to be a consequence of vaginal breech birth.Reducing the number of breech presentations atbirth lowers the risks associated with vaginalbreech birth. External cephalic version (ECV) hasbeen shown to be effective as a preventivemeasure for reducing the number of breechpresentations at birth, as well as the number of caesarean sections because of breech presentation(Hofmeyr, 2003). This procedure was once widelyaccepted and used in obstetrics and midwifery, butlost its popularity among both obstetricians andmidwives around the mid 1970s, primarily becauseof concerns about the safety of the procedure(Bradley-Watson, 1975; Schoon, 1999). Since the publication of the Term Breech Trial (Hannah,2000), there has been growing interest in (re)-introducing this procedure into practice (NVOG,2001; Shennan and Bewley, 2001; KNOV, 2003). The Royal College of Obstetricians and Gynaecologistsrecommends that a skilled service for externalversion should be available and offered for breechpresentation at term (RCOG, 2001).The effectiveness of ECV is influenced by variousfactors. Studies show that maternal and fetalcharacteristics, such as parity, type of breechpresentation, uterine contractility, duration of pregnancy, breech position, ease in palpation of fetal head, uterine contractibility, liquor volume,skills of practitioner and placental position maycontribute to the success of ECV (Ferguson et al.,1987; Lau et al., 1997, Aisenbrey et al., 1999; Regalia et al., 2000). The use of tocolysis, epiduralanaesthesia and fetal acoustic stimulation maypositively influence the success percentage of ECV(Schorr et al., 1997; Hofmeyr and Kulier, 2003). However, the issue of the safety of ECV has alsobeen addressed. Complications associated with ECVinclude uterine rupture, placental abruption, earlyonset of contractions, premature rupture of mem-branes, umbilical cord complications, fetal – mater-nal transfusion, vaginal blood loss, Rhesusantagonism, fetal heart rate pathology, stillbirthand asphyxia (Gjøde et al., 1980; Hofmeyr and Sonnendecker, 1983; Brocks et al., 1984; Kasule, 1985; Brost et al., 1996; Ghidini and Korker, 1999; Lau et al., 2000). The most common of thesecomplications is transient fetal bradycardia notassociated with fetal morbidity (Lau et al., 2000).A meta-analysis showed no difference in neonatalmorbidity (Apgar score under 7 at 5mins, low pH inumbilical vein) and mortality between the ECVgroups and those not having ECV (Hofmeyr andKulier, 2003).A recent systematic review of version-relatedrisks, analysing 44 studies covering a total of 7377women, showed no increase in fetal mortality orserious morbidity after cephalic version. However,variable patterns in fetal heart rate as seen inelectronic fetal monitoring (EFM) (i.e. transientbradycardia or decelerations in the fetal heartrate) frequently occurred, but rarely led tocaesarean section (Collaris and Oei, 2004).Most studies describe the effects and risks of ECVperformed with the use of tocolysis. In the Nether-lands, the use of tocolysis or anaesthesia is notstandard practice. In about 50% of the hospitals inwhich ECV is carried out, no tocolytics are used(NVOG, 2001). Furthermore, ECVs are also carriedout by midwives in primary-care settings, and mid-wives in the Netherlands are not regulated toprescribe tocolytic or anaesthetic medication. TheDutch guideline for obstetricians on ECV does notcontain specific recommendations regarding the useof tocolysis or anaesthesia during ECV (NVOG, 2001).The aim of this study was to gain insight into thesuccess percentage of ECV without the use of tocolysis, and to examine factors associated with asuccessful ECV. We also looked into the effect of the number of ECV attempts on the number of cephalic presentations at birth and the number of caesarean sections. Finally, we examined compli-cations that may have resulted from the procedure.This study is unique because of the large amountof data on ECVs carried out without tocolysis. Thesedata can be added to the existing body of evidenceaddressing the benefits and safety of ECV. We alsodescribe the outcomes of a second ECV withouttocolysis, which, as far as we know, has not beenaddressed before. ARTICLE IN PRESS External cephalic version without tocolysis in the Netherlands 39  Methods This study was developed as part of the educationand research collaboration between the MidwiferySchool in Amsterdam and the research instituteTNO (Institute for Applied Scientific Research)Quality of Life. Eleven final-year midwifery stu-dents designed and carried out the study under thesupervision of two midwife-researchers (KH, MR).The ‘Slotervaart’ Hospital (SLVZ), a regionalhospital affiliated with the Midwifery School of Amsterdam, has a long tradition of carrying outECVs during pregnancy. An average of 200 ECVs arecarried out each year primarily by one singlemidwife and, in her absence, by one singleobstetrician. Pregnant women with a breech pre-sentation are referred from obstetricians workingat the SLVZ and from midwifery practices inAmsterdam and throughout the country. In 1993,the midwife set up an ECV data registration systemfor annual review.Students collected data from ECVs carried outbetween 1996 and 2000 from SLVZ hospital records.Data pertaining to the remainder of the pregnancyand to the birth were collected from the hand-written birth notes and registration forms from 35different midwifery practices. Approval from aResearch Ethics Committee was not required tocarry out this study.Data collected from the ECV register includedparity, duration of pregnancy, success of ECV andthe use of ultrasound or electronic fetal monitoringbefore or after the procedure. From midwiferypractices, data were collected pertaining to thewomen (age, ethnicity), the pregnancy (complica-tions and referrals or consultations for complica-tions possibly associated with the ECV), the birth(presentation at birth and mode of delivery) andthe baby (neonatal morbidity and mortality).Analysis was conducted using SPSS (version 11.5).For the bivariate analyses, the  w 2 test was used forcategorical variables, the student  t -test for con-tinuous variables and the Mann – Whitney U test incase of a skewed distribution. Variables with a  p value under 0.05 were considered statisticallysignificant and were tested in a logistic regressionmodel using backward stepwise selection. Analyseswere undertaken separately for first and secondECV attempts. Findings The study population consisted of 924 womenreferred for ECV in the study period. Thirty-fivecases could not be included in the analysis. In 25 of these cases (2.8%), the women did not undergo theprocedure because of the following reasons: ce-phalic presentation at the time of the consultation( n ¼ 21); the baby’s head was positioned behindthe placenta ( n ¼ 1); or unknown reason ( n ¼ 3). In10 cases (1.1%), no documentation was availableabout the success of the ECV. In total, 958 ECVswere carried out on; 889 first attempts and 69repeat attempts. All ECVs were carried out withoutthe use of tocolysis or epidural anaesthesia.The distribution of baseline characteristics of thestudy population that may influence the success of ECV are shown in Table 1. Results are shownseparately for women who had only one ECV andthose who had two ECVs. No significant differenceswere found between women with one or two ECVattempts.The results of all first and second ECVs, type of professional who carried out the procedures andthe weeks of gestation in which they were carriedout are shown in Table 2. The success rate for ECVwas 41% (364/889) for first attempts and 29% (20/69) for second attempts. More than two-thirds of the first version attempts were carried out beforeterm, between 34 and 37 weeks gestation. Ten percent (7/69) of all second version attempts wereafter 37 weeks. The chance of success of the firstECV attempt increased with every additional parityand with an increase in birth weight of the baby.The chance of success was more than double formultiparous women (64%; 184/290) compared withnulliparous women (29%; 172/598), and almostdouble for non-Dutch women (60%; 87/146) com-pared with Dutch women (38%; 214/561). Firstattempt ECV was also positively influenced byhigher age and longer duration of pregnancy.After adjustment, parity, non-Dutch srcin andbirth weight remained factors that independentlyinfluenced the success of ECV (Table 3). With everypregnancy, the odds ratio for success of ECVincreased almost threefold. Non-Dutch srcin andan incremental increase of 500g birthweightincreased the odds ratio for success almost two-fold. A 20% increase in success was found withevery additional week of pregnancy, but this wasborderline significant. Only 13% of women with anunsuccessful ECV received a second ECV. Parity wasthe only factor contributing to the success of repeat ECV: adjusted OR 4.0 (95% CI 1.4 to 11.3)for every additional parity.The effects of having at least one ECV onclinically relevant outcomes are shown in Table 4.A successful ECV (either at the first or secondattempt) is associated with a large proportion (94%)of women with a baby in cephalic presentation at ARTICLE IN PRESS M. Rijnders et al.40  birth. In 6% of these cases, the baby turned back tobreech presentation. The proportion of cephalicpresentations at birth increased by 3% after asuccessful second ECV. A repeat ECV did not resultin a significant reduction of the proportion of women undergoing caesarean section, but thenumbers involved were small.In all the ECVs, the fetal heart rate was checkedwith a hand-held Doppler before and after theprocedure. An abnormality in the fetal heart ratewas found in 21 cases (2.2%), most of whichwere cases of transient bradycardia (Table 5). Inmost of these cases, continuous electronic-fetalmonitoring was used for further investigation. Three ARTICLE IN PRESS Table 2  Characteristics of the external cephalic version.  Characteristics First ECV attempts ( n ¼ 889) Second attempt ECV ( n ¼ 69) n  %  n  %  n  %  n  %  n  %  n  %Total Successful Not successful Total Successful Not successful364 41 525 59 20 29 49 71Person carrying out ECVMidwife (%) 750 85 307 86 396 85 47 68 17 85 30 61Obstetrician (%) 126 14 44 12 60 13 22 32 3 15 19 39Midwife and obstetrician (%) 5 1 2 1 3 1 0  —  0  —  0  — Duration of pregnancy atdiagnosis of breechMean (SD) 31 (3.6) 31 (3.6) 31 (3.6) 31 (3.4) 31 (3.7) 31 (3.3)Median 31 31 30 31 30 31Duration of pregnancy at time of first ECV32 – 33 completed weeks 7 1 5 1 2  —  0  —  0  —  0  — 34 – 36 completed weeks 613 69 215 61 336 73 62 90 17 85 45 9237 weeks and more 266 30 135 138 124 27 7 10 3 15 4 8Mean (SD) 36 (1.1) 37 (1.2) 36 (1.1) 36 (0.8) 36 (1.0) 36 (0.8)Median 36 36 36 36 36 36  Denominators differ due to missing data; ECV, external cephalic version. Table 1  Baseline characteristics of women (and their babies) who underwent one or two external cephalicversion attempts.  Characteristics Women with one ECV attempt ( n ¼ 820) Women with two ECV attempts ( n ¼ 69) n  %  n  %ParityNulliparous 552 67 46 67Multiparous 267 33 23 33OriginDutch 523 80 38 75Non-Dutch 133 20 13 25Age of woman (years)Mean (SD) 31 (4.5) 31 (5.3)Median 31 31Birth weight baby (g)Mean (SD) 3394 (476) 3438 (465)Median 3400 3493Baby’s genderMale 356 46 38 59Female 423 54 26 41  Denominators differ due to missing data. ECV, external cephalic version. External cephalic version without tocolysis in the Netherlands 41  complications were reported that occurred during orvery shortly after the first ECV had been attempted(Table 5). There was one case of ruptured mem-branes during the ECV, resulting in a spontaneousvaginal breech birth of a healthy baby. One womanwas admitted to hospital for abdominal pain on thesame day she had undergone ECV. A few hours afteradmission, she underwent an emergency caesareansection because of vaginal blood loss and a compro-mised baby. Although this baby was born in poorcondition, it recovered quickly enough to be able toleave the hospital with the mother within a week of birth. One woman had vaginal blood loss and fetalheart rate pathology after ECV, which resulted in anemergency caesarean section for placental abruptionand the birth of a healthy baby. No complicationswere reported after a second attempt at ECV. Therewere no cases of fetal or maternal mortality. Discussion The core data for this study were obtained retro-spectively from a database of practice that had not ARTICLE IN PRESS Table 3  Logistic regression using backward stepwise selection with crude and adjusted odds ratios for factorsthat may influence the success of a first external cephalic version attempt.Independent variables Outcome of first ECV attempts ( n ¼ 889)Successful ECV(%) or (mean)UnsuccessfulECV (%) or(mean)Crude OR with CI95% or  p  valueAdjusted OR with CI 95%OriginDutch ( n ¼ 561) 38.1 61.9Non-Dutch ( n ¼ 146) 59.6 40.4 2.4 (1.7 to 3.5) 1.8 (1.2 to 2.8)Baby’s genderMale ( n ¼ 394) 40.6 59.4Female ( n ¼ 449) 40.8 59.2 1.0 (0.8 to 1.3)  — Person carrying out ECVObstetrician ( n ¼ 126) 35.7 64.3Midwife ( n ¼ 750) 41.9 58.1 0.8 (0.5 to 1.1)  — Parity (0.86) (0.23)  p o 0 : 001 2.8 (2.1 to 3.7)Age of mother (31.6) (30.4)  p o 0 : 001 NSBirth weight of baby (lbs) (7.1) (6.6)  p o 0 : 001 1.7 (1.4 to 2.0)Duration of pregnancy at ECV (36.6) (36.2)  p o 0 : 001 1.2 (1.0 to 1.4)Duration of pregnancy atdiagnosis of breech(31.1) (30.9)  p o 0 : 4  — ECV, external cephalic version. Table 4  Presentation at birth and method of delivery by success of external cephalic version in first attemptand second attempt external cephalic version during pregnancy.Presentation at birth and mode of deliveryCephalic ( n ¼ 352) Non-cephalic ( n ¼ 474)Vaginal( n ¼ 315)Caesarean( n ¼ 37)Vaginal( n ¼ 280)Caesarean( n ¼ 194) n  %  n  %  n  %  n  %Women with only one ECV attemptSuccess 283 87 25 8 9 3 10 3No success 16 4 9 2 243 56 168 38Women with two ECV attemptsSuccess 15 79 3 16 1 5 0  — No success 1 2 0  —  27 61 16 36 Percentages do not add up exactly to 100% due to rounding. M. Rijnders et al.42
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