**4. The term breech trial: Clinical practice implications**

The article: "Elective caesarean vs. vaginal delivery with breech presentation at term: The International Term Breech Trial", was a randomized trial published by Hannah et al. in The Lancet magazine in 2000. The conclusions of the study were immediately adopted by the medical society, leading to a great change in obstetric practice.

The purpose of the study was to create a clinical guideline based on the evidence regarding the best performance to follow with respect to breech presentation. The study was carried

The External Version in Modern Obstetrics 191

(SEGO, as per its Spanish initials) also included these conclusions and recommended in its breech presentation protocol the fact of informing the patient about the results from previous studies. This recommendation has caused an increase in breech presentation caesarians in pregnancies at term. Thus, a study published in 2003 and carried out in 80 centres and 23 countries stated that 92% of the centers studies had opted for the caesarean

The two year monitoring of this same project (published in 2004) did not show any difference between the groups concerning the following aspects: Breast feeding, bonding with the newborn or her partner; subsequent pregnancy; incontinence; depression; urinary, menstrual or sexual problems; fatigue; or distressing memories of the birth experience. The planned caesarean was related to a higher risk of constipation. It is remarkable the fact that the mothers from the planned caesarean group showed less concern about their babies'

After two years, there were not any differences in the perinatal results between the elective caesarean and the elective vaginal delivery, regarding the risk of death or the developmental delay in two years old children. In other words, the lower number of neonatal deaths observed in the project after three months was compensated with a higher number of developmental delay in the elective caesarean delivery group (RCOG, 2006). This was a very surprising result, because three months after the project, performing a planned caesarean delivery proved a reduction both of risk of perinatal death and of severe neonatal morbidity. In conclusion, the planned caesarean delivery is not related to a risk of death reduction or to a developmental delay in two year old children, although this reduction is observed until six months after birth (whyte et al, 2003). Therefore, this new analysis two years after delivery revealed that the initial conclusion could not be maintained, as there were not any significant differences in neonatal morbidity and mortality between both groups. These new conclusions generated debated regarding the recommendations of The Term Breech Trial as the authors continued to reiterate the conclusions from the initial analysis in following papers despite the results obtained after the second year. Projects criticising the methodological reliability and setting out possible biases in Hannah's project. Even though, both the Cochrane and the different national obstetrics and gynaecology societies that adopted the initial results in its recommendations, have not gone into the question again since then. This is not surprising, as the breech presentation delivery is related to many risks from a medico-legal point of view, which makes the caesarean delivery option seem a more convenient option and with lower medico legal risk. Thus, for many obstetricians, Term Breech Trial has become an ideal excuse to adopt a type of delivery they already preferred

All the aforementioned has resulted in a large increase of the caesarean delivery rates over the last few years. For instance, in the United Kingdom, caesarean delivery represented 2% of births in 1953, 18% in 1997 and 21% in 2001. In Norway, the rates has gone from 12,8% in 1999 to 13,0% in 2000 and 14% in 2001. The highest increase took place in the last few months of 2000, concurring with the publication of the Term Breech Trial. In the Netherlands, the caesarean delivery rate with breech presentation went from 50% to 80% in less than two months since the release of the Term Breech Trial (Rietberg

delivery in breech presentation instead of the vaginal delivery (Hogle et al, 2003).

health than the ones from the planned vaginal delivery group (Hannah et al, 2004).

over the other one.

et al, 2005).

out in 121 centres of 26 different countries. It included a total of 2008 pregnant women at term with breech babies. Those women were randomly given the date of the planned caesarean or the planned vaginal delivery. After a three-month monitoring, it was performed a two-year monitoring.

There was a reduction in the neonatal mortality and morbidity in the elective caesarean delivery group when compared with the elective vaginal delivery group, without any significant increase of maternal morbidity or mortality. Furthermore, it was found that the adverse perinatal outcomes were less common when the caesarean had been planned before delivery, while they increased if the caesarean was performed intrapartum.

The subgroup analysis failed to demonstrate any independent association with deliveries performed after long delivery labor, those oxytocin or prostaglandin induced, those cases of incomplete breech presentation, those with unknown breech presentation and those breech presentation deliveries performed by inexperienced obstetricians.

Another subgroup analysis was carried out according to the national perinatal mortality rate (low versus high). In this case, the results showed some changes, obtaining a higher reduction of perinatal mortality in countries with lower national perinatal mortality rate than in those with higher mortality rates. Therefore, the benefits of the at term caesarean will be higher in countries with lower perinatal mortality rates, as it is the case of Spain. One reason for this difference could be that, in these countries, women were discharged at an early stage after the vaginal delivery. Therefore, the collection of neonatal complications has been less complete than the records concerning caesarean-born babies, as they need to stay longer in the hospital.

All subgroups analysis, except the already mentioned one, showed similar risk reductions when using an elective caesarean delivery, compared with the planned vaginal deliveries of the main study (Hannah et al, 2002).

Concerning maternal morbidity, the urinary incontinence occurring three months after delivery was lower in the planned caesarean group. Abdominal pain was more common in the planned caesarean group, while perineal pain was more common in the planned vaginal delivery. There were not statistically significant differences in low back pain, faecal incontinence, postpartum depression, maternal dissatisfaction with the method of care, breastfeeding, bonding with the newborn, bonding with the woman's partner or dyspareunia. However, neither the morbidity associated to uterine scars in subsequent pregnancies nor the ability to carry out everyday activities were evaluated.

As it has been mentioned, the results of the analysis of Hannah's three month after delivery study yield an significant impact for obstetrician practice and were adopted almost immediately by the medical societies. The Cochrane database also published a meta-analysis including *Hannah*'s project. This analysis concluded that the planned caesarean reduces both the perinatal and neonatal morbidity and mortality at the expense of a moderate increase in maternal morbility. These conclusions were included in the national associations of obstetrics and gynecology's clinical guidelines and protocols. Some of these societies are the Royal College of Obstetricians and Gynaecologists (RCOG), the Society of Obstetricians and Gynaecologists of Canada (SOGC) or the American College of Obstetricians and Gynaecologists (ACOG). Obviously, the Spanish Society of Obstetrics and Gynaecology

out in 121 centres of 26 different countries. It included a total of 2008 pregnant women at term with breech babies. Those women were randomly given the date of the planned caesarean or the planned vaginal delivery. After a three-month monitoring, it was

There was a reduction in the neonatal mortality and morbidity in the elective caesarean delivery group when compared with the elective vaginal delivery group, without any significant increase of maternal morbidity or mortality. Furthermore, it was found that the adverse perinatal outcomes were less common when the caesarean had been planned before

The subgroup analysis failed to demonstrate any independent association with deliveries performed after long delivery labor, those oxytocin or prostaglandin induced, those cases of incomplete breech presentation, those with unknown breech presentation and those breech

Another subgroup analysis was carried out according to the national perinatal mortality rate (low versus high). In this case, the results showed some changes, obtaining a higher reduction of perinatal mortality in countries with lower national perinatal mortality rate than in those with higher mortality rates. Therefore, the benefits of the at term caesarean will be higher in countries with lower perinatal mortality rates, as it is the case of Spain. One reason for this difference could be that, in these countries, women were discharged at an early stage after the vaginal delivery. Therefore, the collection of neonatal complications has been less complete than the records concerning caesarean-born babies, as they need to stay

All subgroups analysis, except the already mentioned one, showed similar risk reductions when using an elective caesarean delivery, compared with the planned vaginal deliveries of

Concerning maternal morbidity, the urinary incontinence occurring three months after delivery was lower in the planned caesarean group. Abdominal pain was more common in the planned caesarean group, while perineal pain was more common in the planned vaginal delivery. There were not statistically significant differences in low back pain, faecal incontinence, postpartum depression, maternal dissatisfaction with the method of care, breastfeeding, bonding with the newborn, bonding with the woman's partner or dyspareunia. However, neither the morbidity associated to uterine scars in subsequent

As it has been mentioned, the results of the analysis of Hannah's three month after delivery study yield an significant impact for obstetrician practice and were adopted almost immediately by the medical societies. The Cochrane database also published a meta-analysis including *Hannah*'s project. This analysis concluded that the planned caesarean reduces both the perinatal and neonatal morbidity and mortality at the expense of a moderate increase in maternal morbility. These conclusions were included in the national associations of obstetrics and gynecology's clinical guidelines and protocols. Some of these societies are the Royal College of Obstetricians and Gynaecologists (RCOG), the Society of Obstetricians and Gynaecologists of Canada (SOGC) or the American College of Obstetricians and Gynaecologists (ACOG). Obviously, the Spanish Society of Obstetrics and Gynaecology

pregnancies nor the ability to carry out everyday activities were evaluated.

delivery, while they increased if the caesarean was performed intrapartum.

presentation deliveries performed by inexperienced obstetricians.

performed a two-year monitoring.

longer in the hospital.

delivery.

the main study (Hannah et al, 2002).

(SEGO, as per its Spanish initials) also included these conclusions and recommended in its breech presentation protocol the fact of informing the patient about the results from previous studies. This recommendation has caused an increase in breech presentation caesarians in pregnancies at term. Thus, a study published in 2003 and carried out in 80 centres and 23 countries stated that 92% of the centers studies had opted for the caesarean delivery in breech presentation instead of the vaginal delivery (Hogle et al, 2003).

The two year monitoring of this same project (published in 2004) did not show any difference between the groups concerning the following aspects: Breast feeding, bonding with the newborn or her partner; subsequent pregnancy; incontinence; depression; urinary, menstrual or sexual problems; fatigue; or distressing memories of the birth experience. The planned caesarean was related to a higher risk of constipation. It is remarkable the fact that the mothers from the planned caesarean group showed less concern about their babies' health than the ones from the planned vaginal delivery group (Hannah et al, 2004).

After two years, there were not any differences in the perinatal results between the elective caesarean and the elective vaginal delivery, regarding the risk of death or the developmental delay in two years old children. In other words, the lower number of neonatal deaths observed in the project after three months was compensated with a higher number of developmental delay in the elective caesarean delivery group (RCOG, 2006). This was a very surprising result, because three months after the project, performing a planned caesarean delivery proved a reduction both of risk of perinatal death and of severe neonatal morbidity. In conclusion, the planned caesarean delivery is not related to a risk of death reduction or to a developmental delay in two year old children, although this reduction is observed until six months after birth (whyte et al, 2003). Therefore, this new analysis two years after delivery revealed that the initial conclusion could not be maintained, as there were not any significant differences in neonatal morbidity and mortality between both groups. These new conclusions generated debated regarding the recommendations of The Term Breech Trial as the authors continued to reiterate the conclusions from the initial analysis in following papers despite the results obtained after the second year. Projects criticising the methodological reliability and setting out possible biases in Hannah's project. Even though, both the Cochrane and the different national obstetrics and gynaecology societies that adopted the initial results in its recommendations, have not gone into the question again since then. This is not surprising, as the breech presentation delivery is related to many risks from a medico-legal point of view, which makes the caesarean delivery option seem a more convenient option and with lower medico legal risk. Thus, for many obstetricians, Term Breech Trial has become an ideal excuse to adopt a type of delivery they already preferred over the other one.

All the aforementioned has resulted in a large increase of the caesarean delivery rates over the last few years. For instance, in the United Kingdom, caesarean delivery represented 2% of births in 1953, 18% in 1997 and 21% in 2001. In Norway, the rates has gone from 12,8% in 1999 to 13,0% in 2000 and 14% in 2001. The highest increase took place in the last few months of 2000, concurring with the publication of the Term Breech Trial. In the Netherlands, the caesarean delivery rate with breech presentation went from 50% to 80% in less than two months since the release of the Term Breech Trial (Rietberg et al, 2005).

The External Version in Modern Obstetrics 193

The external cephalic version is an obstetrics performance aiming at turning a breech presentation into a cephalic one, more favourable to vaginal delivery. It can also be used to turn a transverse situation into a longitudinal (breech or cephalic) presentation. However, its current use is exclusively aimed at turning breech presentation into cephalic

This performance was widely used before 1970s, but it began to decline because it was considered an unsafe method. It has been performed from the time of Hippocrates (460-377 BC). Aristotle (384-322 BC) was the author of some texts describing that many doctors

Over the last century, this performance gradually rose until the sixties, when it saw a boom caused by the increasing demand for a less medical intervention at birth. Before the seventies, the cephalic version was performed preterm because it was believed that this process could hardly be successful if it was performed at term. The external cephalic version was included in the daily obstetric practice due to the obvious and immediate effectiveness of the process as well as the results from non-randomized clinical projects. Its popularity began to decline in the mid-seventies due to the doubts raised about its effectiveness and safety. Reports about a considerable perinatal mortality associated to this performance were published (Bradley Watson, 1975) and the caesarian delivery was presented as the safest option against the external cephalic version or breech presentation. That is the reason why this practice was gradually abandoned until becoming an unusual performance. It must be considered that in those times there were neither ultrasound

Subsequent projects proved that the external cephalic version in breech babies at term significantly reduced non cephalic presentation at birth as well as the rates of caesareans with no worse perinatal outcome. This situation, as well as the implantation of the Term Breech Trial's results made the external cephalic version be considered as the best option in

The Cochrane, in a systematic review, assessed the external cephalic version at term effects. The results proved a clinically and statistically significant reduction of breech babies as well as of caesareans deliveries when the external cephalic version was used. No significant effects on perinatal mortality were observed. No significant differences in the incidence on Apgar score were observed (7 at the first minute or at the fifth minute, low umbilical artery

In fact, the Cochrane Foundation recommended offering the external version to every woman with normal pregnancies and breeching presentation at term (37th-42nd week) (level

The cephalic version at term reduces the incidence of breech presentation (risk difference 52%, NNT 2) as well as the caesarean rate (risk difference 17%, NNT 6) at birth. In daily

**6. ECV impact on the reduction of caesarean deliveries and breech** 

advised midwives to handle the baby's head so that it was presented at birth.

**5. External cephalic version (ECV): Concept and history** 

presentations.

scans nor antenatal monitoring.

**presentation at birth** 

PH level or perinatal death.

of recommendation A).

order to avoid the caesarean in breech babies at term.

This phenomenon must be analyzed, as we cannot obviate the non-negligible maternal risk related to caesarean, in spite of having notably decreased in the last few decades, thanks to the improvement of the surgical technique, the anesthesia, the infection control, thromboembolic prophylaxis, etc.

The caesarian is the most indendently associated factor with postpartum maternal mortality and morbidity (Minkoff et al, 2003). The mortality rate associated to elective caesarean almost tripled the vaginal delivery (Hall & Bewley, 1999). It is estimated that caesarean (both elective and urgent) quadruple the severe morbidity risks in comparison with vaginal delivery (Waterstone et al, 2001). Caesarean also increases the number of hospital readmissions. During 1995 and 1998, the Canadian hospital readmission rate during the three months after birth (attributable to complications following their birth) was 3,9% for caesarean delivery while for vaginal delivery was 2,6% (Health Canada, 2000). An American research also revealed higher hospitalization rates after a caesarean, with 1,8 relative risk compared with the vaginal delivery (Lydon-Rochelle, 2000). (Health

Apart from this increase in postpartum morbidity after caesarean, there are also long-term risks and complications. The presence of uterine scars increases the risk of complications in subsequent pregnancies, such as ectopic pregnancy, placenta praevia, placenta accreta, premature placenta detachment and uterine rupture. It has been estimated that every caesarean performed to save a child will produce a uterine rupture in the subsequent pregnancy (Hodnett et al, 2005). In a project carried out in the Netherlands, it was calculated that the increase of 8.500 planned caesarean deliveries, which took place within four years of the Term Breech Trial would have avoided 19 perinatal deaths. However, it caused four avoidable maternal deaths. In subsequent pregnancies, it could cause 9 perinatal deaths caused by uterine rupture and 140 women could suffer complications related to the uterine scar (Palencia et al, 2006). The risk of intra-abdominal adhesions, endometriosis on implantation and adenomyosis. Caesareans have also been associated to emotional problems such as postpartum depression and distressing memories of the birth experience, as well as restrictions in everyday activities, and breastfeeding problems. However, it is not the case among those women electing the caesarian delivery. It has also been suggested that neonatal risks increase in caesarean delivery. Some of these risks are the following: increase in admissions to neonatal units (and mother-infant separations postbirth), iatrogenic prematurity, increase in neonatal respiratory problems and fetal deaths in the subsequent pregnancy.

In view of this situation, it is obvious the adequacy of the external version in pregnant women at term with breech presentation. This is the only performance able to turn a breech presentation into a cephalic presentation. Thus, the inherent risk of breech presentation delivery (both in vaginal or caesarean delivery) seems to disappear. A review of the strategies followed to reduce the caesarean risks identified the external cephalic version (ECV) as the only clinical performance gathering evidence (evidence level I) for the total reduction of primary caesarean rates. A Cochrane's review stated that the ECV implementation at term (≥ 37th week) increases the probability of cephalic presentation at birth and reduces the necessity of a caesarean delivery. Thus, ECV should be recommended in the absence of contraindications for every woman with breech babies.

This phenomenon must be analyzed, as we cannot obviate the non-negligible maternal risk related to caesarean, in spite of having notably decreased in the last few decades, thanks to the improvement of the surgical technique, the anesthesia, the infection control,

The caesarian is the most indendently associated factor with postpartum maternal mortality and morbidity (Minkoff et al, 2003). The mortality rate associated to elective caesarean almost tripled the vaginal delivery (Hall & Bewley, 1999). It is estimated that caesarean (both elective and urgent) quadruple the severe morbidity risks in comparison with vaginal delivery (Waterstone et al, 2001). Caesarean also increases the number of hospital readmissions. During 1995 and 1998, the Canadian hospital readmission rate during the three months after birth (attributable to complications following their birth) was 3,9% for caesarean delivery while for vaginal delivery was 2,6% (Health Canada, 2000). An American research also revealed higher hospitalization rates after a caesarean, with 1,8 relative risk

Apart from this increase in postpartum morbidity after caesarean, there are also long-term risks and complications. The presence of uterine scars increases the risk of complications in subsequent pregnancies, such as ectopic pregnancy, placenta praevia, placenta accreta, premature placenta detachment and uterine rupture. It has been estimated that every caesarean performed to save a child will produce a uterine rupture in the subsequent pregnancy (Hodnett et al, 2005). In a project carried out in the Netherlands, it was calculated that the increase of 8.500 planned caesarean deliveries, which took place within four years of the Term Breech Trial would have avoided 19 perinatal deaths. However, it caused four avoidable maternal deaths. In subsequent pregnancies, it could cause 9 perinatal deaths caused by uterine rupture and 140 women could suffer complications related to the uterine scar (Palencia et al, 2006). The risk of intra-abdominal adhesions, endometriosis on implantation and adenomyosis. Caesareans have also been associated to emotional problems such as postpartum depression and distressing memories of the birth experience, as well as restrictions in everyday activities, and breastfeeding problems. However, it is not the case among those women electing the caesarian delivery. It has also been suggested that neonatal risks increase in caesarean delivery. Some of these risks are the following: increase in admissions to neonatal units (and mother-infant separations postbirth), iatrogenic prematurity, increase in neonatal respiratory problems and fetal deaths in the subsequent

In view of this situation, it is obvious the adequacy of the external version in pregnant women at term with breech presentation. This is the only performance able to turn a breech presentation into a cephalic presentation. Thus, the inherent risk of breech presentation delivery (both in vaginal or caesarean delivery) seems to disappear. A review of the strategies followed to reduce the caesarean risks identified the external cephalic version (ECV) as the only clinical performance gathering evidence (evidence level I) for the total reduction of primary caesarean rates. A Cochrane's review stated that the ECV implementation at term (≥ 37th week) increases the probability of cephalic presentation at birth and reduces the necessity of a caesarean delivery. Thus, ECV should be recommended in the absence of contraindications for every woman with breech

thromboembolic prophylaxis, etc.

pregnancy.

babies.

compared with the vaginal delivery (Lydon-Rochelle, 2000).
